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ABSTRACT

Background

The aim of this study was to compare and evaluate the effect of sensory adapted dental

environment and regular dental environment in reducing anxiety levels in children with

intellectual disability.

Objectives:

1. To evaluate the efficacy of sensory adapted dental environment (SADE) on

cooperation and anxiety levels in children with intellectual disability.

2. To evaluate the efficacy of regular dental environment on cooperation and anxiety

levels in children with intellectual disability.

3. To compare the efficacy of sensory adapted dental environment and regular dental

environment on cooperation and anxiety levels in children with intellectual

disability.

Methodology:

This study was carried out on 24 children with mild intellectual disability aged between 8-

13 years. Developmental screening test was utilized to categorize and include the children

in the study with mild intellectual disability with IQ score between 52-67. Then the

children were randomly allocated and subjected to routine dental prophylaxis into two

different dental environments. In the study group SADE was used and a regular dental set

up in control group. Dental anxiety levels for both the groups, were assessed at baseline,

5 minutes, and at the end of the procedure using the Venham’s anxiety rating scale, pulse

rate and blood pressure values.

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Results: The data was coded and analyzed using software SPSS (IBM version 22.0) for

statistical analysis. Comparison between groups was done using Independent T- test and

repeated measured ANOVA for objective assessment of intergroup and intragroup anxiety

levels respectively, and using Mann Whitney U test and Friedman’s test for subjective

assessment of intergroup and intragroup anxiety levels respectively

Interpretation and Conclusion: The current study suggests that SADE significantly

decreased anxiety levels and cooperative behaviour in children with mild Intellectual

disability and SADE can be used as an alternative behaviour management technique in

effectively handling children with intellectual disability when compared to conventional

behaviour management techniques.

Key words: Behaviour management; SADE; Dental Anxiety; Mild Intellectual disability

ix
Introduction

INTRODUCTION

Special care dentistry is the field of dental practice that provides oral care and treatment

needs for patients with physical, mental, medical problems, or any other limitations. It

majorly involves prevention, diagnosis and treatment services.1 These patients are generally

unable to maintain proper oral health on their own due to lack of motor dexterity 2 and their

dental care is neglected primarily because of insufficient encouragement and awareness

about oral health.1 Therefore, providing primary and comprehensive, preventive and curative

oral care for people with special health care needs is a fundamental element of the paediatric

dentistry speciality.3

Approximately, there are about 650 million individuals who are affected with the disability

which is advancing with the increasing population. According to the reports of United Nation

Development Programme in 2006, about 80% of people having disabilities reside in

developing countries,4 with India being world's largest populated country having children

with high risk of developmental disabilities.5 It can be estimated that there are nearly 24

million individuals in India with intellectual disabilities, out of which 15 million are children

below 10 years of age. Intellectual disability(ID), in former times referred as mental

retardation, is a condition involving significantly sub-average intellectual development from

birth to early childhood.6

Features of this condition comprise of substantial impediments in intellectual functioning

(including learning, reasoning, problem solving) and adaptive functions, which covers

variety of everyday social and practical abilities.7

The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) has

classified four different degrees of intellectual disabilities as: Mild intellectual disability,

1
Introduction

moderate intellectual disability,severe and profound intellectual disability, in which majority

of the population (about 85%) with intellectual disabilities is mildly disabled.6

The etiologic factors for Intellectual disability are various which can be broadly categorized

into hereditary and environmental factors. The hereditary factor being of paramount

importance as there is increased incidence of disabled parents who produce children with

disability. This group of hereditary conditions also involves certain disorders which are

associated with mental retardation like Phenol ketonuria, Cretinism, Microcephaly,

Neurofibromatosis, and Huntington’s chorea. The environmental aspect of causation

affecting intellectual development encompass infections in the prenatal period like viral

infections in the third month including maternal rubella, viral encephalitis, rhesus

incompatibility, fetal irradiation and infections in peri-natal periods such as bacterial

meningitis, anoxia during the time of delivery and traumatic brain injury.8

Children with intellectual disabilities are unable to execute various tasks such as issues in

communication, socialization, as well as looking after themselves. They experience

difficulties with fundamental activities, including eating, dressing, communicating and

walking. They are extremely prone to depression, low self-appreciation and confidence.

They experience challenges in learning, and grasp things at a considerably slower rate than

children who do not have intellectual disability.6

Oral hygiene is a crucial component of overall general health. Good Oral health increases

one's overall quality of life.9 The oral health of individuals is influenced greatly by their

physical and mental capacities, as well as the cooperation and motivation of the support staff.

Unfortunately, oral care of these children is one of the extreme unmet health needs than the

normal population.10 This has been linked to the fact that there are challenges associated with

2
Introduction

practical difficulties during routine treatment sessions, lack of oral health supervision by

parent/caregiver, socioeconomic status, their nutrition, eating pattern, medication, physical

limitations like lack of muscle coordination and awareness about significance of brushing

and flossing, neglecting the treatment needs or pain, obstacles in communication and

cooperation, lack of effective preventive strategies to reduce the need for this care, negative

attitudes of parents and healthcare providers, and lastly insufficient skills of dentists in

providing dental care.10,11

According to various studies people with intellectual disabilities have poor oral health and a

higher incidence of gingivitis. In comparison with normal population, these subjects had the

highest degree of negligence towards dental health.10 Numerous authors noted that amongst

the disabled, the mentally handicapped had a high prevalence of poorer oral health which

was suggested to be the predominant cause of periodontal disease in these individuals.9

Furthermore, reports also suggest that a significant correlation exists between oral hygiene

and periodontal conditions in these children. Grants and Stern have proved that there is

general increase in OHI-S scores as well as extent of periodontal disease with the increase

in age.11

Casamassimo,Seale, and Ruehs (2004) noted that 60–80% of dentists reported that they were

not willing to provide care to disabled population because of their resistive behaviours. Apart

from these, multiple other factors that create barriers to good oral care are anxiety-induced

reactions which can be difficult to manage them resulting in a reduction in access to or

changes in the manner in which dental care is offered.12

Anxiety is physiologic experience that arises when an individual is exposed to stress, which

can be caused by unpredictable or unfamiliar circumstances, medical treatment, or an

3
Introduction

uncomfortable experience.13 For individuals with intellectual disability, anxiety can also

result from cognitive impairments, reduced adaptive behaviours, and perceived increased

vulnerability to environmental demands.12 Anxiety related to dental treatment is one such

barrier, which poses a challenge and can lead to patient’s avoiding dental appointments.

Though all individuals are afflicted by anxiety, various studies have shown that people with

special needs are eminently vulnerable to dental challenges.13 To overcome such behavioural

challenges, the use of sedative drugs or general anaesthesia, have shown to be beneficial.

However, there are still conflicts with the use of these procedures on subjects with

disabilities,14 as these behaviour management strategies can be costly, often necessitating

treatment in a more specialised facility, such as a hospital, rather than an outpatient dental

office.12

According to American Academy of Paediatric Dentists, Hand over mouth and Physical

Restraint techniques have been disregarded in the management of these children while

performing various oral care procedures, as they pose a major obstacle in managing stronger

and active patients with mental disabilities. Moreover, these techniques are not only

traumatizing to the patient but can also cause inconvenience to the operator as well as dental

staff, therefore compliance from dental staff and public for these techniques have been

reasonably inferior. Furthermore, as acceptance of restraint techniques decrease, behavioural

challenges in the dental chair among those with intellectual disabilities continue to increase.

Around 53% of dentists used restraint preferably rather than sedation to treat a child with

disability in order to overcome behaviour problems in the dental clinic. However, use of

restraints could not only lead to dental fear but also reluctance in visiting dentist

subsequently. Positive ways for behaviour management do exist that place accentuation on

reinforcement and remodelling without the utilization of restraint procedures. There is a

4
Introduction

predictability that with the utilization of such strategies as systematic desensitization, in vivo

desensitization, differential reinforcement, a more extensive acknowledgment by patients,

caretakers as well as by the dental practitioners would be accomplished.14

In regular dental environment(RDE) disabled children are sensitive and easily invoked to

sensory stimuli such as high-speed hand piece, overhead light, loud ambient noises, texture

and taste of prophylaxis paste.15 This altered neurophysiological predisposition of

individuals with developmental disability encountered in regular dental set up could

negatively impact their behaviour and level of cooperation making it more difficult for

dentists to provide treatment.16 Stein et al suggests that there exists a relationship between

sensory over-responsivity and uncooperative behaviours in the dental office.17

Health professionals have studied sensory-based treatment in dental management of people

with developmental disability. This Sensory-based treatments are intended to give

individualized, regulated sensory experiences in order to modulate responses to external

stimuli. They aim to promote sensory processing and self-regulation, boost adaptive

function, and assist the child in participating in daily activities. However, there is not a

universally accepted protocol for implementing sensory-based treatment into practice.

Sensory-based treatment has been researched in the dental field as a novel technique to

reduce dental anxiety in children.15

A cross-over trial in 2009 reported that sensory adaptive technique was very productive in

dental treatment amongst children with neurological and developmental disorder compared

to those children treated in a regular dental environment. Effect of sensory adaption showed

substantial cooperation in children and they were reported to be found relaxed. Another

study in 2011 reported that there were difficulties in the behavioural management of children

5
Introduction

with disabilities, especially those with autism, however, the result showed that the sensory

environment helped a lot to facilitate dental care.18

The sensory-adapted dental environment (SADE) comprises of a specialised room with

controlled multi-sensory stimuli that is partially lighted, with relaxing music. SADE has

been proposed to help people with developmental disabilities, Alzheimer's illness, and

traumatic brain injury, improve their quality of life by reducing anxiety, pain, and unrest. 16

However, the efficacy of sensory-based treatments are yet to be conclusive.

Apparently, there are no studies done regarding the use of SADE in children with mild

intellectual disabilities. Also, the present study employed the concept of camouflaging the

instruments aiming to additionally supplement decreased anxiety during dental procedures

in children with mild intellectual disabilities. As the literature lacks the data regarding the

use of sensory adapted dental environment based upon the Snoezelen environment and

camouflaging instruments during a routine scaling procedure in children with mild

intellectual disability. So, the present study was framed to compare and evaluate the effect

of sensory adapted dental environment and regular dental environment in reducing anxiety

levels in children with intellectual disability.

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Aim and Objectives

AIM AND OBJECTIVES

1. AIM OF THE STUDY:

• To compare and evaluate the effect of sensory adapted dental environment and

regular dental environment in reducing anxiety levels in children with intellectual

disability.

2. OBJECTIVES OF THE STUDY:

• To evaluate the efficacy of sensory adapted dental environment on cooperation and

anxiety levels in children with intellectual disability.

• To evaluate the efficacy of regular dental environment on cooperation and anxiety

levels in children with intellectual disability.

• To compare the efficacy of sensory adapted dental environment and regular dental

environment on cooperation and anxiety levels in children with intellectual

disability.

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Review of Literature

REVIEW OF LITERATURE

According to AAPD, Intellectual disability (ID) is defined as ‘‘a condition of arrested or

incomplete development of mind, which is specially characterized by impairment of skills

manifested during the developmental period, which contribute to the overall level of

intelligence, i.e., Cognitive, language, motor, and social abilities’’.8

The clinical signs and symptoms of intellectual disability are diagnosed as early as between

infancy and childhood. This predominant clinical presentation significative of intellectual

disability vary depending upon the specific cause and the severity of cognitive deficit. While

infants and young children with severe intellectual deficit profoundly have a characteristic

clinical presentation with an underlying cause, alternatively a large percentage of children

with mild intellectual disability are unlikely to present clinical symptoms and may go

unrecognized until 5–9 years of age or even late childhood.19

DIAGNOSIS OF INTELLECTUAL DISABILITY

Diagnosis of intellectual disability requires a formal and individualized assessment of

cognitive and adaptive functions using standardized tests in accordance with broadly

established definitional criteria. It is important to use standardized assessment tools to assess

intellectual disability, because it is difficult to infer an individual’s intellectual function

based on conversations and observations alone.20

There are various tools for assessment of intellectual disabilities.6 The developmental tests

yield “developmental quotients” which are interpreted in the same way as IQ scores.21

Some of the Developmental screening tests are:

i. Revised Denver Pre-screening Developmental Questionnaire

ii. Kansas Infant Development Screen

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iii. Bayley Scales of Infant Development

iv. Developmental Screening Test (DST) by Bharat Raj

vi. Functional Assessment Check List for Programming (FACP) 6

Developmental Screening Test (DST) by Bharat Raj

Developmental Screening Test developed by Bharath Raj (1977, 1983) is a simple, reliable

and a valid assessment test which aims to measure the developmental sequence of children

from birth to 15 years of age. It consists of 88 items which represents the behavioural

characteristics of various age groups. In each age group, items are drawn from behavioural

areas, such as motor development, language, speech, and social development. The evaluation

of the child can be done through semi-structured interviews with parents or caregiver of the

child. The IQ calculator assimilated with the test folder helps to calculate the IQ of children

from the mental and chronological age. Developmental screening test is a reliable and valid

test with a very high positive correlation of +.7215 to +.9968 with other tests.22

Grading of development as per score obtained from Bharat Raj’s Developmental

Screening Test: -

52-67 Mild retardation

36-51 Moderate retardation

20-35 Severe retardation

Less than 20 Profound retardation

Approximately 85% of patients with intellectual disability have mild severity. The IQ score

for mild disability is between 50–70. They have difficulties in acquiring and understanding

complex academic and language skills.19

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Review of Literature

A study was done by Verma et al in 1979 on cross validation of Developmental Screening

Test administered among 170 children aged between 1-15 yrs. Gesell drawing test, Vineland

Social Maturity Scale, were also administered along with this by dividing the children into

3 groups 1-5, 6-10, 11-15 years. The results showed that DST showed a very high positive

correlations with other developmental tests, which proved it to be a valid test for all 3 age

groups. Interscorer reliability and test-retest reliability were found to be high than other

tests.23

BARRIERS IN ORAL HEALTH CARE IN INTELLECTUAL DISABLED

CHILDREN:

When considering the oral health of these individuals, there are often reports that they have

significant dental needs, and these needs are often untreated barriers that make it difficult

for these patients to attain the necessary dental care.24

Various barriers seeking dental services have been classified by the Federation Dentaire

Internationale as:

(a) Individuals themselves

(b) The dental profession

(c) Society 25

Barriers with reference to the dental profession:

Experienced and trained personnel equipped with specialized programs, clinics, and

facilities are necessary for managing such patients.9 A majority of studies cited the most

common causes for dentists to neglect to provide dental care is because of the patient’s

behaviour, dental disease severity, disability associated and inadequate training and

experience in treating this population as major obstacles.24

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Review of Literature

Other factors related to these health inequalities such as high employee turnover, lower

levels of trust and cooperation, uneven distribution, insufficient sensitivity to the needs and

requirements of patients, lack of information about treatment, lack of knowledge and

funding, restricted physical environment, lack of accessible language and communication

skills.26

As increased time and efforts are required, dental practitioners tend to abstain from treating

patients with intellectual disability.9

Barriers with reference to society:

Inadequate awareness in community, negative oral health promotion attitudes, insufficient

oral healthcare facilities and human resource planning.26

Barriers with reference to the individual:

These individuals face difficulty following instructions, inability to perform oral health self-

care, anxiety or fear due to previous traumatic experiences, lack of awareness of oral health

care by caregivers, low expectations and issues related to accessibility.26

A cross sectional study designed by Bhaskar et al aimed to analyse the barriers to oral care,

evaluate the oral hygiene and dmft index in 331 school children with disabilities aged

between 6–14 years old in Kochi. They were divided into groups including intellectually

handicapped, hearing impaired, visually handicapped, and orthopaedic handicapped.

Pretested structured questionnaire was given to parents/caretakers to obtain information

regarding access to care and clinically the dentition status and OHI-S index was recorded.

The results showed that 68.6% of them reported financial difficulty as the most significant

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Review of Literature

obstacle to dental care, which was higher among intellectually handicapped (39%) with a

2.81 ± 3.4 dmft score higher among them than others.27

Leal Rocha L et al conducted a cross-sectional study to investigate the dental services

accessibility, the dental services requirements, and factors impacting the use of dental

services by people with motor, visual, and hearing impairments in Brazil. The study

comprised of structured questionnaires which were distributed among dentists and disabled

people. They concluded that 43.1% of disabled people failed to prioritize their basic health

care, 52.5% did not generally pursue dental care, and amongst those who seek care ,76.3%

found it difficult to receive care ,84.5% only seek emergency care and 45% are not aware of

the services provided. Among the dentists 43.8% reported insufficient physical access

infrastructure with 60% of dentists reporting of the transportation difficulties and unsafe

environment as barriers.28

Krsihanan L et al conducted a study which aimed to estimate the health care barriers faced

by children with disability from caregivers and dental professional’s perspectives. A

prevalidated questionnaire was given to 195 dentists and 100 caregivers. The study

concluded that about 83.7% of dentists proclaimed insufficient training in managing the

special needs children, whereas 38% caretakers reported fear of dentist among these

children. Therefore, they suggested there is a need to improve the dental setup to provide

comfort care to these children.29

Alfaraj A et al surveyed to evaluate the barriers in accessing dental care among caretakers

in Saudi Arabia using a questionnaire distributed among 186 caretakers of children with

special health care needs. They concluded that 60.8% of caregivers faced lack of time for

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Review of Literature

getting access to dental care,53.9% reported unsuitable clinic environment,51.9% had

difficulties with transportation.30

ANXIETY

‘Anxiety’ is an emotional state that occurs before actually encountering a threatening

stimulus, and sometimes goes unnoticed whereas ‘dental fear’ is a response to a threatening

stimulus in dental situation. The overwhelming and irrational fear of dentistry related to

destructive feelings such as terror, irritability, high blood pressure, and restlessness is known

as "odontophobia" and is diagnosed as a specific phobia under the International Statistical

Classification of Diseases and Related Health Problems (ICD)-10 and DSM-IV.31

Extreme fear is negatively associated with the frequency of dental visits and perceived oral

health. Numerous studies have shown that people with disabilities have high levels of fear

and anxiety.9 According to Algras et al dental anxiety has been proclaimed as the fifth-most

prevalent cause of anxiety.31

According to Deb et al (2001) and Ramirez & Lukenbill (2007), individuals with intellectual

disability experience more mood and anxiety disorders than normal population. Emerson

and Hatton (2007) reported that in comparison to people without intellectual disability, those

with intellectual disability have 3-4 times increased risk of emotional, behavioural and

anxiety related problems.32 This anxiety experienced by individuals with intellectual

disability affects the desire to avoid dental care, more than the external factors like

transportation and cost, which will definitely affect overall dental health.24

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Review of Literature

SENSORY TRIGGERS OF DENTAL ANXIETY

Anxiety can be triggered by the sensory stimuli, such as the sight of needles, sounds of cavity

cutting with airotor, the smell of eugenol, and the sensation of high-frequency vibrations in

the dental environment.31

A study was done by Fallea et al to evaluate the prevalence of dental anxiety in borderline

intellectual functioning and individuals with mild and moderate intellectual disability, and

to investigate the correlation of dental anxiety with their age and gender among 700

participants aged 6-47 years old. Dental Anxiety Scale was utilized to assess their level of

dental anxiety. The results of the study suggest that mild intellectually disabled population

had 40.61% slight anxiety,18.79 % moderate anxiety,17.5% high anxiety,10.91 % severe

anxiety and dental anxiety was high in younger population with increased prevalence in

females.33

A study done by Keles et al to determine the effect of dental anxiety on oral health related

quality of life in 86 mildly intellectual disabled children. Oral health of the children on their

quality of life and its association with anxiety levels were assessed using Oral health-related

quality of life-United Kingdom Scale, Oral Health Impact Profile-14 and Modified Dental

Anxiety Scale respectively. The results of the study showed that around 30% of individuals

with mild intellectual disability were shown to have dental anxiety and with the increase in

dental anxiety the oral health-related quality of life decreased in these children.34

Assessment Of Dental Anxiety:

There are many ways to assess children's dental fear and anxiety. Among the many options,

the four main types of assessment tools can be grouped according to the types of information

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Review of Literature

collected. They are: - Self-report assessment, Parental proxy assessment, Observation-based

assessment, and Physiological assessment.35

Physiological Assessment (Objective Assessment)

Fear-anxiety plays significant role in the cardiovascular changes occurring during dental

treatment. These responses stimulate the adrenal medulla to release endogenous epinephrine

which causes the peripheral arteries to constrict and can therefore increase blood pressure.

Heart rate is directly affected by the autonomic nervous system and can increase with

hormonal epinephrine.36

A study was done to evaluate the effect of dental treatment procedures on pulse rate and

peripheral oxygen saturation among 100 children aged 6-10 year old. The children were

categorized under 5 dental procedures; including 3 invasive (GIC filling extraction,

Pulpotomy) and 2 non-invasive (scaling and polishing, fluoride application) procedures. The

pulse oximeter was used to record the findings in each child at 5 different times involving

child in play area, child in dental operatory, child on the dental chair prior to treatment,

during the procedure and post treatment. The O2 saturation and pulse rate was evaluated at

each time and recorded. The pulse rate increased subsequently for all the treatment

procedures with its highest recorded value of 134bpm for scaling and polishing.37

Another study evaluated the behavioural and physiological variations during sequential

dental visits and its effect on age and sex among 115 children, between 4-11 years of age.

The child's response was determined using oxygen saturation, blood pressure, heart rate, and

cooperative behaviour. The variables were observed and recorded when the child was in the

waiting room, after initial examination, before and after oral prophylaxis, before and after

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Review of Literature

cavity preparation, before and after extraction. The results concluded that a significant

increase in change in the systolic blood pressure and heart rate in all the situations in the

dental operatory. The diastolic pressure also showed a significant change from the initial

waiting period to the period after initial examination.38

Subjective Assessment (Observation Based)

Venham’s Anxiety Rating Scale

Venham’s anxiety scale is one of the most reliable indicators of dental anxiety. Venham’s

anxiety scale is a 6 point scale (0-5), which describe the child's anxiety level and explain the

most likely behaviour pattern.39

Advantages of rating scales include ease of approach and recording,40 with a high degree of

clarity and reliability even for untrained observer.41 The evaluator uses trait (anxiety) as an

organizing concept, allowing him to select relevant cues and superimpose dimensions on the

subject's behaviour. It has significant correlations indicating that greater anxiety and

uncooperative behaviour were associated with more highly stressed physiological and self-

report measures.40

In a report given by Venham et al, the children’s response to dental stress as assessed by

Venham’s anxiety rating scale showed it to be a reliable and valid scale which could be

easily integrated into clinical and research activities. This study further validated the scales,

the results of which prove Venham’s anxiety rating scale as a standard tool for behavioural

assessment.40

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Review of Literature

MANAGEMENT OF DENTAL ANXIETY IN INTELLECTUALLY

HANDICAPPED CHILDREN:

The AAPD endorses the traditional behavioural guidance such as communication guidance,

voice control, Tell-Show-Do, non-verbal communication, positive reinforcement,

distraction, and nitrous oxide sedation to guide children throughout the dental treatment and

to assist in building their coping skills. However, these approaches are insufficient to engage

children with developmental disability due to unique deficits associated with their

disabilities. Furthermore, the psychological and physical impairments, including sensory

processing difficulties make it even more difficult for children with developmental disability

to cooperate and tolerate dental treatment.15

The use of Hand over mouth (HOM) and Hand over mouth airway restricted (HOMAR) has

been declined in the dental practice. Utilizing these restrictive methods of behaviour

management has raised concerns majorly due to liability and legal issues and potential

effectiveness of alternative less restrictive techniques for behaviour management during

dental procedures in these children. Also, there is lack of evidence on the efficacy of HOM

or HOMAR in reducing disruptive behaviour in children. They cannot be employed as a

behaviour management technique for individuals with intellectual disabilities requiring

dental treatment.42

A study done by Conyers et al compared in vivo desensitization with video modelling for

increasing compliance with dental procedures in 6 individuals with severe or profound

intellectual disabilities. The authors reported that both video modelling and desensitization

were effective in gaining compliance. However extensive time was required for the

desensitization, furthermore, no information was presented on the long-term impact of the

use of desensitization and modelling.43

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Review of Literature

Stark et al. (1989) investigated the use of distraction technique in reducing anxious and

disruptive behaviour in 4 children, as assessed by direct observation in a multiple baseline

design.42 Allen and Stokes (1989) also reported that distraction technique alone is

insufficient to decrease uncooperative behaviour.44 However this technique has not been

applied to individuals with intellectual disability.42

In another study, a tape-slide series was developed using a desensitization and modelling

approach, prior to initial dental examination of children with DD. The children who were

not exposed to series served as a control group. Behaviour of children was assessed using

heart rate, a modified Melamed's scale, and a dentist's subjective evaluation. The results

showed that children exposed to tape-slide series showed worse behaviour and a higher heart

rate than children not exposed to the series.45

Since individuals with intellectual disability remain unaffected by the behaviour of those

around, modelling technique is relatively less effective in them.44

Another study evaluated parental acceptance for use of restraints during dental procedure in

children with intellectual disabilities. Participants were interviewed and they also watched a

video on physical restraint techniques, sedation, and general anaesthesia. Only 22.9% of the

parents accepted general anaesthesia. 50.7% parents considered active restraint, 55.9%

passive restraint, and 58.9% considered sedation, with no statistically significant difference

for acceptance of any of these methods, with general anaesthesia being the least accepted

method of restraint.46

There has been limited attention to development of alternative methods based on the

functional analysis of atypical behaviour for behaviour management of these children, there

is a great need for implementation of intervention programmes for individuals with

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Review of Literature

intellectual disability who require dental treatment for both those with and without

challenging behaviours.42

The sensory adaptive technique is one such technique which has been developed based on

Snoezelen environment. This environment consists of a dental clinic with certain lightning

effects, vibrations, calming music, and aromas.18 This concept intends to stimulate the

elementary senses of sight, touch, feel, and smell, along with patient-centred therapy.31 Since

sensory processing disorders are ubiquitous in those with developmental disability, sensory

flooding leads to emotional discomfort manifesting as high level of anxiety and

uncooperative behaviour. So, providing these children with developmental disability with

an environment in which aversive stimuli is substituted by gentler stimuli, like soft moving

light effects, calming music, and deep pressure, the children would become more focused on

the pleasant stimuli, with reduced awareness of discomforting stimuli,16 therefore

diminishing their fear and anxiety, thus improving their behaviour.18

STUDIES

A study was done to investigate the effect of a sensory-adapted dental environment (SADE)

on anxiety, relaxation, and cooperation of children with developmental disabilities among

16 children aged 6-11 years old with moderate to severe developmental disability. The

children’s cooperation level during the treatment was recorded using the anxiety and

cooperation scale. Utilizing negative dental behaviour checklist, the duration of anxious

behaviours was measured, electrodermal activity was monitored by changes in the skin

conductance. The mean duration of anxious behaviours was low and substantial increase in

relaxation and cooperation in the SADE as opposed to the regular dental environment

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Review of Literature

(RDE), indicating the significance of considering the sensory-adapted environment as a

preferable dental environment for this population.47

Another study was done to determine the effect of sensory adapted environment in

diminishing the behavioural and arousal levels among 16 children aged between 6-11 years

with moderate to severe developmental disability in comparison with 19 age matched normal

children during dental prophylaxis procedure. They evaluated the duration of anxious

behaviours and electrodermal activity before and after the dental procedure. They concluded

that SADE was significantly more beneficial in effectively decreasing anxiety levels in

disabled population than in normal children.16

A study evaluated the impact of SADE in diminishing agitation and anxiety levels during

dental prophylaxis among 41 adult participants with intellectual and developmental

disability compared to RDE. They assessed the blood pressure, heart rate and behavioural

parameters such as duration and frequency of agitated behaviours through video recordings.

The study concluded that SADE effectively reduced the duration and frequency of agitated

behaviours compared to RDE.48

A pilot study was done to assess the effect of a sensory adapted dental environment in

reducing anxiety during routine oral care among 22 children with developmental disabilities

including neurodevelopmental disabilities, Autism Spectrum Disorder, Down syndrome,

Developmental delay, Cerebral palsy, and disabilities associated with chromosomal

disorders. Random allocation was done among the children, each subjected into two dental

setups, one in SADE and other in RDE with a recall period of 3-4-months. They measured

the heart rate, oxygen saturation, frankl behaviour scale to assess the anxiety levels in these

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children. They concluded that Frankl scores were significantly increased in SADE in

comparison to RDE. SADE was also strongly preferred by 46% of parents for their child’s

further dental treatment proving it to be beneficial in controlling behavioural issues in these

children.15

Another pilot study examined the impact of a sensory adapted dental environment (SADE)

in decreasing discomfort and pain perception during routine oral prophylaxis among 44

children aged 6–12 year old with autism spectrum disorder (ASD). This crossover trial

assessed the physiological anxiety, pain intensity, behavioural distress, and sensory

discomfort among the participants undergoing prophylaxis in SADE and RDE each. The

results concluded that there was decreased anxiety, sensory discomfort and pain in the SADE

condition in comparison to RDE, proving it to be effective in the behaviour management of

these children.17

Another study aimed to evaluate the anxiety levels among 19 children aged 6-11 year old

undergoing routine prophylaxis in SADE. They evaluated behavioural parameters through

the videotaped recordings such as number, magnitude and mean duration of anxious

behaviours. The physiological parameters were recorded by evaluating changes in dermal

resistance. They concluded that there was significant decrease in anxiety levels in SADE

compared with conventional dental environment which proved SADE to be effective in

anxious children undergoing dental procedures.49

21
Methodology

METHODOLOGY

This present in vivo, randomized clinical trial was conducted on 24 children with mild

intellectual disability with an age range of 8-13 years in the Department of Paedodontics

and Preventive Dentistry, Bapuji Dental college and hospital, Davangere, Karnataka,

India, for oral prophylaxis procedure. The study was approved by Ethical Committee

(Ref.No.BDC/Exam/509/2019-20) from the Institutional Review Board, Bapuji Dental

College and Hospital, Davangere and written informed consent from the legal

guardian/care taker of patients willing to participate in the study was taken after

explaining the whole procedure.

INCLUSION CRITERIA:

• Children with the age group of 8-13 years.

• Children with mild intellectual disability with IQ level between 50-69.

• Children who are systemically healthy.

EXCLUSION CRITERIA:

• Children with moderate to severe intellectual disability.

• Children with any other concomitant diseases or syndromes.

22
Methodology

SAMPLE SIZE DETERMINATION:47

Sample size was calculated using G Power Software version

Significance level was fixed at 0.05

Power of the study was fixed at 20% (0.8)

Effect size was fixed at 1.21(calculated based on the results of previous study)

The calculated sample size was 12 per group. The total sample size was 24.

MATERIAL USED:

• Customized handles for mouth mirror

• Customized handles for scalers

• Customized mouth mask

• Butterfly wrap

• Plane mouth mirrors

• Scalers

• Explorers

• Tweezers

• Kidney trays

• Suction tips

• Cotton rolls

• Disposable gloves

• Regular Mouth masks

23
Methodology

EQUIPMENT REQUIRED:

• Portable Music system

• LED colour bulbs

• Pulse oximeter (Choicemmed)

• Digital sphygmomanometer (OMRON)

PROCEDURE: A general examination of children after taking consent from the legal

guardian/care taker was done prior to the study, to assess if he/she comes under selection

criteria. Developmental screening test was conducted for determining IQ level of the

children with intellectual disability and the children were divided into two groups.

SCREENING OF INTELLECTUALLY DISABLED CHILDREN

DEVELOPMENTAL SCREENING TEST

SELECTED INTELLECTUALLY DISABLED


CHILDREN

RANDOMIZATION

REGULAR DENTAL SENSORY ADAPTED


ENVIRONMENT DENTAL ENVIRONMENT

24
Methodology

24 Mentally retarded children were included in the study.

Group – 1 Intellectually disabled Children to be treated Sample size – 12

under regular dental environment


(control)

Group – 2 Intellectually disabled Children to be treated Sample size - 12

(experimental) under sensory adapted dental environment

DEVELOPMENTAL SCREENING TEST:22

This test is designed for the purpose of measuring intellectual development of children

with intellectual disability from birth to 15 years of age. The test provides a brief and

fairly dependable assessment without requiring the use of performance tests.

ADMINISTRATION:

DESCRIPTION OF THE MATERIAL: Developmental schedule consists of a simple

chart with items on it. These items are arranged age wise from 3 months to 15 years.

The items progressively depict greater level of physical and social maturity and

independence.

Instruction to use:

The tester starts with items closest to chronological age of child to establish a ‘basal

age’. This is the age at which all items are likely to be passed or the behavior described

is likely to be present. Gradually tester moves through upper age levels. Each item could

be evaluated either by observing the child (e.g.: head is steady, walks) or by asking the

parents (comb hair by self) or by asking the child (repeat 3 digits).

In each group the child should succeed in at least 60% of the items.22

25
Methodology

The IQ of the child will be calculated using the formula:

IQ= MENTAL AGE X 100

CHRONOLOGICAL AGE

PROCEDURE:

• Children with mild intellectual disability requiring oral prophylaxis

treatment were considered in the study. Randomization among the children

fulfilling the inclusion criteria was done by picking up chits as to which

environment the child will be exposed to.

Intellectually disabled Children treated under regular dental environment:17,48

• After random allocation in the control group, the oral prophylaxis was done

in the standard manner in a small dental room. Anxiety level of the patients

was recorded using physiologic and psychologic parameters.

• The pulse rate was recorded using pulse oximeter and blood pressure

recordings were measured with a digital sphygmomanometer at the start of

the treatment, five minutes after starting the treatment and after completion

of the treatment.

• Children’s level of cooperation during the treatment was recorded on

completion of each treatment using the anxiety and cooperation scale given

by Veerkamp et al (modified VENHAM'S clinical ratings for anxiety and

cooperative behaviour). This standardized scale includes a score range of 0

to 5 according to the child’s behaviour.

26
Methodology

Intellectually disabled Children treated under sensory adapted dental

environment :17,48

After random allocation of children in the experimental group the following specific

modifications were done in the dental room:-

1) VISUAL: Regular dental overhead lamp was turned off, and slow-moving

visual colour effects were displayed onto the ceiling in the child ‘s visual field.

2) CAMOUFLAGING THE INSTRUMENTS: The handles of the instruments

were covered with toys.

3) HEAD LAMP: The head mounted lamp was used to direct light into the child’s

mouth.

4) AUDITORY: Rhythmic music was played through portable speakers.

5) TACTILE: This stimulus consisted of a wrap designed to look like a butterfly

which was wrapped around the child to produce a calming effect. And oral

prophylaxis was carried out in a standard manner. Anxiety level of the patients

was recorded using physiologic and psychologic parameters.

• The pulse rate was recorded using pulse oximeter and blood pressure

recordings were measured with a digital sphygmomanometer at the start of

the treatment, five minutes after starting the treatment and after completion

of the treatment.

• Children’s level of cooperation during the treatment was recorded on

completion of each treatment using the anxiety and cooperation scale given

by VeerKamp et al (modified VENHAM'S clinical ratings for anxiety and

cooperative behaviour).

27
Methodology

VENHAM'S clinical ratings (modified) of anxiety and cooperative behaviour:50

0- Relaxed, smiling, willing, able to converse, best possible working conditions.


Displays the behaviour desired by the dentist spontaneously, or immediately
upon being asked.
1- Uneasy, concerned. During stressful procedure may protest briefly and quickly
to indicate discomfort. Hands remain down or partially raised to signal
discomfort. Child willing and able to interpret experience as requested. Tense
facial expression. Breathing is sometimes held in ("high chest"). Capable of
cooperating well with treatment.
2- Tense tone of voice, questions and answers reflect anxiety. During stressful
procedure, verbal protest, (quiet) crying, hands tense and raised but not
interfering much. Child interprets situation with reasonable accuracy and
continues to work to cope with his/her anxiety. Protest more distracting and
troublesome. Child still complies with request to cooperate. Continuity is
undisturbed.
3- Reluctant to accept the treatment situation, difficulty in assessing situational
threat. Pronounced verbal protest, crying. Using hands to try to stop procedure.
Protest out of proportion to threat or is expressed well before the threat. Copes
with situation with great reluctance. Treatment proceeds with difficulty.
4- Interference of anxiety and ability to assess situation. General crying not
related to treatment. Prominent body movements, sometimes needing physical
restraint. Child can be reached through verbal communication, and eventually
with reluctance and great effort begins to work to cope. Protest disrupts
procedure.
5- Out of contact, with the reality often threat. Hard, loud crying,screaming,
swearing. Unable to listen to verbal communication. Regardless of age, reverts
to primitive flight responses. Actively involved in escape behaviour. Physical
restraint required.

28
Methodology

Developmental Screening Test used in the study for screening children:51

3 years 4years 5 years

Toilet control Tells stories Goes about neighborhood


present

Takes food by self Repeats 3 digits Gives sensible answers to


questions

Begins to ask why? Plays cooperatively Describes actions in pictures


with children

Knows name, uses Comprehends Dresses with no supervision


of common objects ‘hunger’, ‘cold’

Relates experiences Buttons up Makes simple drawings

Copies 0 Defines words

6 years 7years 8 years 9 years

Enjoys constructive Knows comparative Tells time Bathes self-unaided


play value of coins
Gains admission to Enjoys group play Competition in Muscle coordination games
school school/play (marbles)

Writes simple words Spells, reads, writes Makes small Favorite of fairy tales
simple words purchases
Plays games Tells difference of Combs hair by Recognizes property rights
governed by rules, objects self
Can name primary Adapts to home, school Reads on own initiative
colors Tells day, month, year

29
Methodology

10 years 11 years 12 years 13 years

Can stay away from Able to discuss Capable of self- Understands abstract
ideas(justice)
home (camps) problems criticism

Sex differences in play Physical feats liked More independent Interested in dressing up

become marked in spending

Goes about town freely Comprehends social Enjoys books, Plays difficult games

situations Newspapers,

magazines

Has various hobbies, Writes occasional Learns from experience

collections short letters

Cooperates keenly with Shows foresight, planning,


judgement
companions

30
Methodology

SAMPLE SIZE DETERMINATION:47

Sample size was calculated using G Power Software version

Significance level was fixed at 0.05

Power of the study was fixed at 20% (0.8)

Effect size was fixed at 1.21(calculated based on the results of previous study)

The calculated sample size was 12 per group. The total sample size was 24.

23
Results

RESULTS

The present study was conducted in the Department of Pedodontics & Preventive

Dentistry at Bapuji Dental College & Hospital, Davangere, Karnataka, India with the aim

to evaluate the effect of sensory adapted dental environment and regular dental

environment in reducing anxiety levels in children with intellectual disability. A sample

of 24 children with mild intellectual disability aged 8-14 years were selected for the study

for routine oral prophylaxis procedure. The children were accordingly divided into the

control and study groups. The data was collected, coded and analyzed using software

SPSS (IBM version 22.0) for statistical analysis. The data was subjected to normality test

and then Parametric tests were used. The recorded and analysed values are presented in

tables and graphs respectively. The results were analysed using Independent T- test and

repeated measured ANOVA for objective assessment of intergroup and intragroup anxiety

levels respectively, and using Mann Whitney U test and Friedman’s test for subjective

assessment of intergroup and intragroup anxiety levels respectively and p<0.05 was

considered statistically significant.

The results of the present study were evaluated under the following headings: -
1. Masterchart I: Compiled data representing the control group.

2. Masterchart II: Compiled data representing the study group.

3. Table 1: Intergroup comparison of Pulse Rate, Systolic and Diastolic Blood

Pressure values at baseline,5 minutes,at the end of the procedure.

4. Table 2: Intergroup comparison of Venham’s Anxiety Rating Scale at

baseline, 5 minutes, at the end of the procedure.

5. Table 3: Intragroup comparison of Study group based on Pulse Rate, Systolic

and Diastolic Blood Pressure at various time intervals.

39
Results

6. Table 4: Intragroup pairwise mean difference of Study group based on Pulse

Rate, Systolic and Diastolic Blood Pressure at various time intervals.

7. Table 5: Intragroup comparison of Study group based on Venham’s Anxiety

Rating Scale at various time intervals.

8. Table 6: Intragroup comparison of Control group based on Pulse Rate,

Systolic and Diastolic Blood Pressure at various time intervals.

9. Table 7: Intragroup pairwise mean difference of Control group based on

Pulse Rate, Systolic and Diastolic Blood Pressure at various time intervals.

10. Table 8: Intragroup comparison of Control group based on Venham’s

Anxiety Rating Scale at various time intervals.

11. Graph 1: Intergroup comparison based on Pulse rate at baseline, 5 minutes,

at the end of the procedure.

12. Graph 2: Intergroup comparison based on Systolic blood pressure at baseline,

5 minutes, at the end of the procedure.

13. Graph 3: Intergroup comparison based on Diastolic blood pressure at

baseline, 5 minutes, at the end of the procedure.

14. Graph 4: Intergroup comparison based on Venham's Anxiety Rating Scale at

baseline, 5 minutes, at the end of the procedure.

15. Graph 5: Mean difference in the study group for Pulse Rate, Systolic and

Diastolic Blood Pressure at the various time interval.

16. Graph 6: Distribution of Mean rank of study group for Venham’s Anxiety

Rating Scale at baseline, 5 minutes, at the end of the procedure.

17. Graph 7: Mean difference in the control group for Pulse Rate, Systolic and

Diastolic Blood Pressure at the various time intervals.

40
Results

18. Graph 8: Distribution of Mean rank of control group for Venham’s Anxiety

Rating Scale at baseline, 5 minutes, at the end of the procedure.

Observations from Table 1 and Graphs 1,2,3:

Table 1 shows the Intergroup comparison of 3 different parameters that are pulse rate,

systolic and diastolic blood pressure values between the study and control group at

baseline, 5 minutes, at the end of the procedure.

1) There were no statistically significant differences noted in the Pulse Rate at

baseline in the study and control group(p>0.05). The mean value of pulse rate at 5

minutes in the study group was 80.50 and standard deviation was 8.48, the mean

value of pulse rate at 5 minutes in the control group was 99.00 and standard

deviation was 21.83 which showed statistically significant difference with a p-

value of 0.012. The mean value of pulse rate at the end in the study group was

83.25 and standard deviation was 9.25, the mean value of pulse rate at the end in

the control group was 108.50 and standard deviation was 26.03 which showed

statistically significant difference with a p-value of 0.004.

2) There were no statistically significant differences noted in the systolic blood

pressure at baseline in the study and control group (p>0.05). There were no

statistically significant differences noted in the systolic blood pressure at 5 minutes

in the study and control group (p>0.05). The mean value of systolic blood pressure

at the end of the procedure in the study group was 118.08 and standard deviation

was14.77, the mean value of systolic blood pressure at the end of the procedure in

the control group was136.67 and standard deviation was 13.73 which showed

statistically significant difference with a p-value of 0.004.

41
Results

3) There were no statistically significant differences noted in the diastolic blood

pressure at baseline,5 minutes, and at the end of the procedure in the study and

control groups

Therefore, the independent sample T-test showed statistically significant decrease in

Pulse rate at 5 minutes and at the end of the procedure in the study group than the

control group and statistically significant decrease in Systolic Blood Pressure at the

end of the procedure. There were no statistically significant differences noted in the

Pulse Rate at baseline, Systolic Blood Pressure at baseline and at 5 minutes and

Diastolic Blood Pressure throughout the procedure between the study and control

groups.

Observations from Table 2, and Graph 4 :

Intergroup comparison of Venham’s Anxiety Rating Scale using the repeated measured

ANOVA test in study group and control group at baseline,5 minutes, at the end of the

procedure showed:

1) There were no statistically significant differences noted in Venham’s Anxiety

Rating Scale at baseline between the study and control groups. (p>0.05).

2) The mean rank of Venham’s anxiety rating scale at 5 minutes in the study group

was 7.46 and sum of ranks was 89.5, the mean ranks of Venham’s anxiety rating

scale at 5 minutes in the control group was 17.54 and sum of ranks was 210.5

which showed high statistically significant difference with a p-value of 0.000.

3) The mean rank of Venham’s anxiety rating scale at the end in the study group was

6.67 and sum of ranks was 80, the mean rank of Venham’s anxiety rating scale at

42
Results

the end in the control group was 18.33 and sum of ranks was 220 which showed

high statistically significant difference with a p-value of 0.000.

Observations from Table 3:

Intragroup comparison of Study group based on pulse rate, systolic and diastolic blood

pressure at various time intervals showed:

1) The mean value of pulse rate in the study group at baseline was 92.42 and standard

deviation was 14.28. The mean value of pulse rate at 5 minutes was 80.50 and

standard deviation was 8.48. The mean value of pulse rate at the end was 83.25

and standard deviation was 9.25 which showed statistically significant difference

with a p-value of 0.006.

2) The mean value of systolic blood pressure at baseline was 129.00 and standard

deviation was 9.39. The mean value of systolic blood pressure at 5 minutes was

126.25 and standard deviation was 9.96. The mean value of systolic blood pressure

at the end of the procedure was 118.08 and standard deviation was 14.77 which

showed statistically significant difference with a p-value of 0.000.

3) The mean value of diastolic blood pressure at baseline was 73.58 and standard

deviation was 15.76. The mean value of diastolic blood pressure at 5 minutes was

69.42 and standard deviation was 16.95. The mean value of diastolic blood

pressure at the end was 66.58 and standard deviation was 16.95 which showed

statistically significant difference with a p-value of 0.001.

43
Results

Observations from Table 4 and Graph 5:

Intragroup pairwise mean difference of Study group based on pulse rate, systolic and

diastolic blood pressure at various time intervals showed:

1) The mean difference value of pulse rate at baseline and pulse rate at 5 minutes in

the study group was 11.92 which showed statistically significant difference with a

p-value of 0.003.The mean difference value of pulse rate at baseline and pulse rate

at the end was 9.17 which showed statistically significant difference with a p-

value of 0.01.There was no statistically significant difference in the mean

difference value of pulse rate at 5 minutes and pulse rate at the end in the study

group (p>0.05).

2) There was no statistically significant difference in the mean difference value of

Systolic Blood Pressure at baseline and Systolic Blood Pressure at 5 minutes in

the study group (p>0.05).The mean difference value of Systolic Blood Pressure at

baseline and Systolic Blood Pressure at the end in the study group was 10.92 which

showed statistically significant difference with a p-value of 0.001. There was no

statistically significant difference in the mean difference value of Systolic Blood

Pressure at 5 minutes and Systolic Blood Pressure at the end in the study group

(p>0.05).

3) There was no statistically significant difference between the mean difference value

of Diastolic Blood Pressure at baseline and at 5 minutes in the study group

(p>0.05). The mean difference value of Diastolic Blood Pressure at baseline and

Diastolic Blood Pressure at the end was 7.00 which showed statistically significant

difference with a p-value of 0.01. The mean difference value of Diastolic Blood

Pressure at 5minutes and Diastolic Blood Pressure at the end was 2.83 which

showed statistically significant difference with a p-value of 0.005.

44
Results

Observations from Table 5 and Graph 6:

Intragroup comparison of Study group based on Venham’s Anxiety Scale at various time

intervals showed:

1) The mean ranks of Venham’s anxiety rating scale in the study group at baseline

was 2.79, at 5 minutes was 1.79 and at the end was 1.42, which showed high

statistically significant difference with a p-value of 0.000.

Observations from Table 6:

Intragroup comparison of Control group based on pulse rate, systolic and diastolic blood

pressure at various time intervals showed:

1) There was no statistically significant difference in the mean value and standard

deviation of pulse rate at baseline, 5 minutes, and at the end in the control

group(p>0.05).

2) The mean value of systolic blood pressure in the control group at baseline was

130.00 and standard deviation was 11.28. The mean value of systolic blood

pressure at 5 minutes was 133.67 and standard deviation was 13.53. The mean

value of systolic blood pressure at the end of the procedure was 136.67 and

standard deviation was 13.73 which showed statistically significant difference

with a p-value of 0.001.

3) There was no statistically significant difference in the mean value and standard

deviation of diastolic blood pressure at baseline,5 minutes, and at the end in the

control group(p>0.05).

45
Results

Observations from Table 7 and Graph 7:

Intragroup pairwise mean difference of Control group based on pulse rate, systolic and

diastolic blood pressure at various time intervals showed:

1) There was no statistically significant difference between the mean difference value

of pulse rate at baseline and at 5 minutes, between the pulse rate at baseline and at

the end and between the pulse rate at 5 minutes and at the end in the control group

(p>0.05).

2) The mean difference value of Systolic Blood Pressure at baseline and Systolic

Blood Pressure at 5 minutes in Control group was -3.67 which showed statistically

significant difference with a p-value of 0.03. There was no statistically significant

difference in the mean difference value of Systolic Blood Pressure at baseline and

Systolic Blood Pressure at the end (p>0.05). There was no statistically significant

difference in the mean difference value of Systolic Blood Pressure at 5 minutes

and Systolic Blood Pressure at the end (p>0.05).

3) There was no statistically significant difference between the mean difference value

of Diastolic Blood Pressure at baseline and at 5 minutes, between the Diastolic

Blood Pressure at baseline and at the end, and between the Diastolic Blood

Pressure at 5minutes and at the end in the Control group (p>0.05).

46
Results

Observations from Table 8 and Graph 8:

Intragroup comparison of Control group based on Venham’s Anxiety Scale at various time

intervals showed :

1) The mean ranks of Venham’s anxiety rating scale in the study group at baseline

was 1.42, at 5 minutes was 1.88 and at the end was 2.71 , which showed high

statistically significant difference with a p-value of 0.000.

47
Results

TABLES

Table 1: Intergroup comparison based on pulse rate, systolic and diastolic blood

pressure

Parameter Groups Mean Std. Sig.

Deviation

Pulse rate at baseline Study group 92.42 14.28 0.8

Control group 94.00 15.89

Pulse rate at 5 minutes Study group 80.50 8.48 0.012*

Control group 99.00 21.83

Pulse rate at the end Study group 83.25 9.25 0.004*

Control group 108.50 26.03

Systolic Blood Pressure at baseline Study group 129.00 9.39 0.82

Control group 130.00 11.28

Systolic Blood Pressure at 5 minutes Study group 126.25 9.96 0.14

Control group 133.67 13.53

Systolic Blood Pressure at the end Study group 118.08 14.77 0.004*

Control group 136.67 13.73

Diastolic Blood Pressure at baseline Study group 73.58 15.76 0.40

Control group 67.75 17.61

Diastolic Blood Pressure at 5 minutes Study group 69.42 16.95 0.95

Control group 69.83 12.48

Diastolic Blood Pressure at the end Study group 66.58 16.95 0.41

Control group 71.92 13.91

48
Results

Table 2: Intergroup comparison of Venham Anxiety Scale

Parameter Groups Mean Sum of

Rank Ranks Sig.

Venham Anxiety Scale at baseline Study group 10.29 123.5 0.095

Control group 14.71 176.5

Venham Anxiety Scale at 5 minutes Study group 7.46 89.5 0.000*

Control group 17.54 210.5

Venham Anxiety Scale at the end Study group 6.67 80 0.000*

Control group 18.33 220

Table 3: Intragroup comparison of Study group based on pulse rate, systolic and

diastolic blood pressure at various time intervals

Parameter Mean Std. Wilks'

Deviation Lambda Sig.

Pulse rate at baseline 92.42 14.28 0.35 0.006*

Pulse rate at 5 minutes 80.50 8.48

Pulse rate at the end 83.25 9.25

Systolic Blood Pressure at baseline 129.00 9.39 0.20 0.000*

Systolic Blood Pressure at 5 minutes 126.25 9.96

Systolic Blood Pressure at the end 118.08 14.77

Diastolic Blood Pressure at baseline 73.58 15.76 0.24 0.001*

Diastolic Blood Pressure at 5 minutes 69.42 16.95

Diastolic Blood Pressure at the end 66.58 16.95

49
Results

Table 4: Intragroup pairwise mean difference of Study group based on pulse rate,

systolic and diastolic blood pressure at various time intervals

(I) Time (J) Time Mean Sig.

Difference

(I-J)

Pulse rate at baseline Pulse rate at 5 minutes 11.92 0.003*

Pulse rate at baseline Pulse rate at the end 9.17 0.01*

Pulse rate at 5 minutes Pulse rate at the end -2.75 0.53

Systolic Blood Pressure at baseline Systolic Blood Pressure at 5 minutes 2.75 1.00

Systolic Blood Pressure at baseline Systolic Blood Pressure at the end 10.92 0.001*

Systolic Blood Pressure at 5 minutes Systolic Blood Pressure at the end 8.17 0.28

Diastolic Blood Pressure at baseline Diastolic Blood Pressure at 5


4.17 0.20
minutes

Diastolic Blood Pressure at baseline Diastolic Blood Pressure at the end 7.00 0.01*

Diastolic Blood Pressure at 5 Diastolic Blood Pressure at the end

minutes 2.83 0.005*

Table 5: Intragroup comparison of Study group based on Venham Anxiety Scale at

various time intervals

Parameter Mean Sig.

Rank

Venham Anxiety Scale at baseline 2.79 0.000*

Venham Anxiety Scale at 5 minutes 1.79

Venham Anxiety Scale at the end 1.42

50
Results

Table 6: Intragroup comparison of Control group based on pulse rate, systolic and

diastolic blood pressure at various time intervals

Parameter Mean Std. Wilks'

Deviation Lambda Sig.

Pulse rate at baseline 94.00 15.89 0.65 0.118

Pulse rate at 5 minutes 99.00 21.83

Pulse rate at the end 108.50 26.03

Systolic Blood Pressure at baseline 130.00 11.28 0.25 0.001*

Systolic Blood Pressure at 5 minutes 133.67 13.53

Systolic Blood Pressure at the end 136.67 13.73

Diastolic Blood Pressure at baseline 67.75 17.61 0.94 0.715

Diastolic Blood Pressure at 5 minutes 69.83 12.48

Diastolic Blood Pressure at the end 71.92 13.91

51
Results

Table 7: Intragroup pairwise mean difference of Control group based on pulse

rate, systolic and diastolic blood pressure at various time intervals

(I) Time (J) Time Mean Sig.

Difference

(I-J)

Pulse rate at baseline Pulse rate at 5 minutes -5 0.66

Pulse rate at baseline Pulse rate at the end -14.5 0.22

Pulse rate at 5 minutes Pulse rate at the end -9.5 0.85

Systolic Blood Pressure at baseline Systolic Blood Pressure at 5 minutes -3.67 0.03*

Systolic Blood Pressure at baseline Systolic Blood Pressure at the end -6.67 0.31

Systolic Blood Pressure at 5 minutes Systolic Blood Pressure at the end -3 1.00

Diastolic Blood Pressure at baseline Diastolic Blood Pressure at 5 minutes -2.08 1.00

Diastolic Blood Pressure at baseline Diastolic Blood Pressure at the end -4.17 1.00

Diastolic Blood Pressure at 5 minutes Diastolic Blood Pressure at the end -2.08 1.00

Table 8: Intragroup comparison of Control group based on Venham Anxiety Scale

at various time intervals

Parameter Mean Sig.

Rank

Venham Anxiety Scale at baseline 1.42 0.000*

Venham Anxiety Scale at 5 minutes 1.88

Venham Anxiety Scale at the end 2.71

52
Results

GRAPHS

Graph 1: Intergroup comparison based on pulse rate


120.00

100.00

80.00
Mean

60.00

40.00

20.00

0.00
Pulse rate at 5
Pulse rate at baseline Pulse rate at the end
minutes
Study group 92.42 80.50 83.25
Control group 94.00 99.00 108.50

Graph 2: Intergroup comparison based on systolic blood pressure


140.00

135.00

130.00

125.00
Mean

120.00

115.00

110.00

105.00
Systolic Blood Systolic Blood Systolic Blood
Pressure at baseline Pressure at 5 minutes Pressure at the end
Study group 129.00 126.25 118.08
Control group 130.00 133.67 136.67

53
Results

Graph 3: Intergroup comparison based on diastolic blood pressure


76.00

74.00

72.00

70.00
Mean

68.00

66.00

64.00

62.00
Diastolic Blood Diastolic Blood Diastolic Blood
Pressure at baseline Pressure at 5 minutes Pressure at the end
Study group 73.58 69.42 66.58
Control group 67.75 69.83 71.92

Graph 4: Intergroup comparison based on Venham's Anxiety


Scale
20
18
16
14
Mean Rank

12
10
8
6
4
2
0
Venham Anxiety Scale Venham Anxiety Scale Venham Anxiety Scale
at baseline at 5 minutes at the end
Study group 10.29 7.46 6.67
Control group 14.71 17.54 18.33

54
Results

Graph 5: Mean difference in the study group for pulse rate, systolic and
diastolic blood pressure at the various time intervals
14.00
12.00
10.00
Mean difference

8.00
6.00
4.00
2.00
0.00
-2.00
-4.00
Systolic Systolic Systolic Diastolic Diastolic Diastolic
Pulse Pulse Pulse Blood Blood Blood Blood Blood Blood
rate at rate at rate at 5 Pressure Pressure Pressure Pressure Pressure Pressure
baseline baseline minutes at at at 5 at at at 5
baseline baseline minutes baseline baseline minutes
Systolic Systolic Systolic Diastolic Diastolic Diastolic
Pulse Pulse Pulse Blood Blood Blood Blood Blood Blood
rate at 5 rate at rate at Pressure Pressure Pressure Pressure Pressure Pressure
minutes the end the end at 5 at the at the at 5 at the at the
minutes end end minutes end end
Mean Difference (I-J) 11.92 9.17 -2.75 2.75 10.92 8.17 4.17 7.00 2.83

Graph 6: Mean rank of study group for Venham Anxiety Scale


3

2.5

2
Mean Rank

1.5

0.5

0
Venham Anxiety Scale Venham Anxiety Scale Venham Anxiety Scale
at baseline at 5 minutes at the end
Mean Rank 2.79 1.79 1.42

55
Results

Graph 7: Mean difference in the control group for pulse rate, systolic and
diastolic blood pressure at the various time intervals
0

-2

-4
Mean difference

-6

-8

-10

-12

-14

-16
Systolic Systolic Systolic Diastolic Diastolic Diastolic
Pulse Pulse Pulse Blood Blood Blood Blood Blood Blood
rate at rate at rate at 5 Pressure Pressure Pressure Pressure Pressure Pressure
baseline baseline minutes at at at 5 at at at 5
baseline baseline minutes baseline baseline minutes
Systolic Systolic Systolic Diastolic Diastolic Diastolic
Pulse Pulse Pulse Blood Blood Blood Blood Blood Blood
rate at 5 rate at rate at Pressure Pressure Pressure Pressure Pressure Pressure
minutes the end the end at 5 at the at the at 5 at the at the
minutes end end minutes end end
Mean Difference (I-J) -5 -14.5 -9.5 -3.67 -6.67 -3 -2.08 -4.17 -2.08

Graph 8: Mean rank of control group for Venham Anxiety Scale


3

2.5

2
Mean Rank

1.5

0.5

0
Venham Anxiety Scale Venham Anxiety Scale Venham Anxiety Scale
at baseline at 5 minutes at the end
Mean Rank 1.42 1.88 2.71

56
Discussion

DISCUSSION

Hallmarks of intellectual disability include the deficiencies in both intellectual and

adaptive functioning. With the progression in research and comprehension on

importance of cultural and social elements for an individual's intellectual functioning,

the term has evolved from idiocy to mental retardation to intellectual disability.

Intellectual disability has overall impact in all functional domains on a person’s growth

and development. They need a variable degree of guidance in education, support to

access health care, community participation as well as encouragement. By the

definitional criteria, intellectual disability must be recognized during developmental

years of the child. In children with severe intellectual disability, the signs and symptoms

are recognized clinically at an early age during the first 3 years of life, however the

children with mild intellectual disability are difficult to recognize and may not be

identified until later age of 4–6 years and up to 9 years new cases could be identified.

Therefore, in this present study, children with mild intellectual disability were included

who were aged between 8-13 years. The assessment of intellectual disability using

standardized tools is important as it is difficult to infer an individual’s intellectual

functioning solely based on conversation and observation.20

Thus, in this study we utilized the developmental screening test (DST) by Bharat Raj,

as it is a highly reliable and valid test to assess and evaluate the IQ level of children

with intellectual disability and categorize those with IQ scores of 52-67 under mild form

of disability and include them in the study.

Children with special needs, due to constraints imposed by their disabled condition have

increased chances of developing caries and periodontal diseases leading to pain,

premature exfoliation and further consequences affecting their overall quality of life.

57
Discussion

They face challenges to maintain proper oral hygiene due to lack of manual dexterity

that hinder day to day oral health practice thereby exhibiting a poor oral hygiene

status.52 Burtner et al reported that the other major obstacles faced by the dentists were

lack of adequate knowledge, skills and training to provide dental care to these

individuals.53

Most of these children with developmental disabilities exhibit extreme anxiety which

makes dental intervention aversive for this population.43 Martin et al (2002) showed

that 43.2% of this population reported dental fear as a major barrier to obtain

comprehensive oral health care among them.54

There are several nonpharmacological therapies for managing these children in dental

setting and to reduce maladaptive behaviours and improve oral health care. Among

those various techniques, there is a distinct therapy method which is now gaining much

emphasis is the multisensory stimulation (Sensory adapted dental environment). This

multisensory-stimulating environment is generally presented in a relaxing and

pleasurable space known as the “Snoezelen room”. This has been proven effective in

managing individuals with learning disabilities as well. The term “Snoezelen” is a

derived from two Dutch words; ‘Snuffles’ which means to sniff out or discover one’s

environment, and “doezelen,” means to doze or relax. So primarily, the Snoezelen

multisensory environment is a well-illuminated room comprising of slow-moving

lighting, calming sound, along with precise tactile sensation.52

These particular multisensory stimuli were utilized to serve various purposes. Firstly,

the room was partially dimmed, curtailing any disturbing visual stimuli. Direct

fluorescent lighting has been reported as flashing and extremely disturbing to eyes. So,

this lighting in the dental chair was switched off and was substituted with soft-coloured,

58
Discussion

slowly repetitive moving lights. Previous reports have documented the negative effects

of noise, showing that higher noise levels may elevate blood pressure, and increase heart

and respiration rates. Therefore, in order to camouflage the second sensory stimuli, that

is the ‘noise’, soft music was played in the background to distract the children from the

regular loud sounds of the dental equipment (e.g:- airotor, suction etc).The third

sensation was the deep pressure. Somatic sensation was provided by means of deep

pressure via the butterfly wrap in this study.47 The wings of the butterfly were wrapped

around the child from shoulders to ankles which provided deep “hugging” pressure

input designed to produce a calming effect.17 Research by Fertel-Daly et al and

Vandenberg support the use of weighted vests (an effect similar to the “butterfly”) for

reducing maladaptive behaviours and calming and improving attention in special needs

children.47 The main difference between the butterfly and a traditional papoose board is

that the main body of the butterfly slips over the dental chair, thereby not requiring the

child be strapped to a board such as that used for the papoose.17

Butterfly wrap provided a sort of protective stabilization to the child in this study, so as

any discomfort arises, we had a protocol that the children could request to keep open

the butterfly wings or ask to close it during the scaling procedure.

A.K.Khoshali (2011) in his study observed that children with mild mentally retardation

appear to make greater use of toys than children with moderate mentally challenged.55

In this study, elimination of visual input of scaling instruments was done in order to

conceal the child’s sight by camouflaging them with colourful child friendly toys to

reduce anxiety during the procedure.

Since Sensory adapted dental environment is one of the novel techniques to manage

disabled children in dental clinic, the present study utilized this technique to evaluate

59
Discussion

the efficacy of SADE compared to a RDE on anxiety levels of these children and to

reduce the sensory-aversive characteristics of the environment, during a dental scaling

procedure. The estimated sample size for this in-vivo study was 24 children with mild

ID, aged between 8-13 years that were randomly allocated into two groups comprising

a regular dental setup and a sensory adapted dental set up.

Previous study done by Shapiro et al showed the potential role of the sensory adapted

environment modification in creating a calming effect among children with

developmental disabilities which was demonstrated by evaluation of both behavioural

and physiological parameters.47

Contemporary ways of assessment of dental anxiety includes the objective and the

subjective measures. Objective assessment is a record of physiological functions of the

body. The psychophysiological responses produced by anxiety are related to increased

activity of the sympathetic branch of the autonomic nervous system consequently

leading to changes that occur in the cardiovascular system such as increased pulse rate

and blood pressure, changes in the sweat glands such as increased electrical

conductivity of the skin, in the muscles such as increased muscle tone, spasmodic

movements, etc., in the respiratory system such as increased respiratory rate and in the

digestive system such as dry mouth, constipation etc. Various studies done by Myers et

al (1972), Messer (1977), Beck and Weaver (1981) have demonstrated that these

physiological changes occurring in the body are very useful assessment tool as they are

due to anxiety and stress experienced by the patients during dental procedures. The

results of these studies were in conjunction with studies done by Laufer and Chosack

(1964) and McCarthy (1957) which concluded that heart rate and blood pressure can be

used as safe and reliable indicators of anxiety, as they increase simultaneously with

stress and anxiety during dental procedures.56


60
Discussion

Pulse oximeter device is one of the most acceptable methods for measuring the

physiological changes as it gives pulse rate values continuously.57 Pulse oximeter

functions by positioning any pulsating arterial vascular bed between two-wavelength

light sources and a detector. The magnitude of the light is dependent on change in the

arterial pulse, the wavelength of light and oxygen saturation of the arterial haemoglobin.

Therefore, a pulsatile waveform corresponding to the pulse rate and oxygen saturation

levels of the patient is detected on the device.58 Aughey et al found that the heart rate

displayed by the pulse oximeter closely approximated the heart rate displayed by the

ECG monitor.59 Hence, in this study dental anxiety was objectively measured by

recording of pulse rate values before, during and after the procedure using a pulse

oximeter device.

In reference to a study conducted by Potter et al, the mean scores of heart rate, systolic

and diastolic blood pressure were lower during the dental cleaning under Sensory

adapted dental environment when compared to Regular dental environment.48 Similar

findings were observed in this study where in the mean value of pulse rate at 5 minutes,

at the end and systolic blood pressure at the end were lower during oral prophylaxis

showing a statistically significant results with a p-value of 0.012, 0.004 and 0.004

respectively. In relation to values of diastolic blood pressure in this present study, there

was no statistically significant results found at baseline, 5minutes and at the end of the

procedure.

The intragroup comparison in the study group (i.e. Sensory adapted dental environment)

also showed statistically significant decrease in pulse rate, systolic and diastolic blood

pressure from baseline to the end of the procedure when compared to regular dental

environment where in the readings increased consistently from baseline to the end of

61
Discussion

the procedure indicating increased dental anxiety among these children in the regular

dental environment.

Another way to evaluate children’s dental anxiety is by observational-based assessment.

This is facilitated by relying on a descriptive rating scale, where the evaluator observes

the child throughout the dental procedure and gives a score apt for the child’s

behavioural response.60 Therefore in this present study, the child’s dental anxiety was

assessed by using the Venham’s anxiety rating scale. This scale is an interval rating

scale, wherein a rank order relationship exists and the distance between any two

neighbouring scale points are of known size. Therefore, a truly quantitative

measurement of dental anxiety is possible with the Venham’s anxiety rating scale.40

The results of the comparison of Venham’s anxiety rating scale among the study group

before, during and after the procedure showed a statistically significant reduction in

dental anxiety. The intergroup comparison showed statistically significant decrease in

anxiety at five minutes and at the end of the procedure in the SADE, and significant

increase in anxiety in regular dental environment. These results showed similar findings

to studies conducted by Shapiro et al which reported shorter duration of anxious

behaviours in the adapted environment when compared to control group as assessed by

NDBC(negative dental behaviour checklist).16 The results were also in agreement with

previous study done by Cermak et al where the children were relaxed and cooperative

during the dental procedure in SADE compared to control group as assessed by

Venham’s anxiety rating scale.17 Our study results were also identical to the results

obtained by Shapiro et al where there was decreased anxious behaviours and increased

cooperation levels as evaluated by Venham’s rating scale in normal children and also

children with developmental disability.47,49

62
Discussion

This study shows the possible significance of sensory-adapted environment

modification in providing a soothing effect among children with developmental

disabilities undergoing a dental procedure. This was proven through the analysis of both

behavioural and physiological characteristics. Majority of these children have extreme

general anxiety. This helps to explain why this group finds dental intervention aversive.

A major assumption underlying this study was that the sensory alteration of a potentially

frightening environment, along with a shift in sensory inputs, leading to increased

comfort and reduction in anxiety. The sensory environment is thought to cushion and

hence shield the individual from harsh stimuli by lowering the intensity of visual,

auditory, and tactile inputs. Furthermore, the altered sensory environment causes the

participants attention to be focused solely on the moving visual and auditory stimuli, as

well as the deep pressure, resulting in a "altered state" with the inevitable reduction in

awareness of unpleasant stimuli. In SADE, the room was dimmed to reduce any

distracting visual cues. Williams backs this viewpoint, claiming that individuals who

are too sensitive to visual stimuli have trouble filtering out distinct wavelengths of light.

As a result, visual perception becomes overloaded, and it becomes difficult to make

sense of visual inputs. Furthermore, one of the observations made during the present

research was that significantly less anxious behaviours were noted among the children

due to the soft, relaxing music played in the background which distracted the child from

harsh stimuli involving regular loud sounds of the dental equipment. Another reason for

decreased anxiety was produced by a butterfly wrap swaddled around the child which

created a sensation of deep pressure.47

In the SADE, several participants reacted positively to the multisensory equipment. Few

participants liked the multi colour projection on the wall, while others reciprocated in a

positive way to the relaxing and calming music played in the background. There were

63
Discussion

no negative comments about the SADE. This indicated that this novel behaviour

management technique was effective in handling children with mild intellectual

disability by reducing their anxiety levels while undergoing dental treatment.

The results of this study were also in agreement with a systematic review done by Ismail

et al (2021) which emphasized the importance of multisensory-adapted dental

environment in improving oral health behaviour among special needs children in terms

of physiological changes, behaviours, pain, and sensory discomfort.52

This study exclusively tried to assess the dental anxiety of children when subjected to

routine dental scaling procedures in two different dental environments before, during

and at the end of the procedure using observational assessment of Venham’s anxiety

rating scale, along with two physiological parameters which are known indicators of

dental anxiety that were the blood pressure and pulse rate. Assessing these physiological

parameters in children with mild intellectual disability during the scaling procedure to

evaluate their anxiety levels for effective behaviour management was not done in

previous studies, hence this study was attempted.

64
Conclusion

CONCLUSION

The following conclusions can be drawn from the study:

• There was a statistically significant reduction in dental anxiety in the sensory

adapted dental environment compared to regular dental environment when

assessed using Venham’s Anxiety Rating Scale, pulse rate and blood pressure

values.

• The sensory adapted dental environment utilized in this research is a innovative,

non-pharmacological, noninvasive approach to induce relaxation and decrease

anxiety during the dental treatment.

• It proved to be effective in reducing sensory stimuli, increase cooperation and

has potential to significantly provide oral health care for all children, specifically

for those with developmental disabilities.

Recommendations:

Within the limitations of the present study, further studies with larger sample

size should be carried out. Also, a multi-visit assessment of dental anxiety using

the objective measures and subjective measures, involving various other dental

treatment procedures should be undertaken.

65
Summary

SUMMARY

This present invivo, randomized clinical trial was conducted on 24 children with mild

intellectual disability with an age range of 8-13 years in the Department of Paedodontics

and Preventive Dentistry, Bapuji Dental college and hospital, Davangere, Karnataka,

India, for oral prophylaxis procedure. The study was approved by Ethical Committee

(Ref.No.BDC/Exam/ 509 / 2019-20) from the Institutional Review Board, Bapuji

Dental College and Hospital, Davangere and written informed consent from the legal

guardian/care taker of patients willing to participate in the study was taken after

explaining the whole procedure.

SELECTION CRITERIA

Inclusion criteria:

• Children with the age group of 8-13 years.

• Children with mild intellectual disability with IQ level between 50-69.

• Children who are systemically healthy.

Exclusion criteria:

• Children with moderate to severe intellectual disability.

• Children with any other concomitant diseases or syndromes.

Methodology:

A general examination of children after taking consent from the legal guardian/care

taker was done prior to the study, to assess if he/she comes under selection criteria.

66
Summary

Developmental screening test was utilized to categorize and include the children in the

study with mild intellectual disability with IQ score between 52-67.Then the children

were randomly allocated and subjected to routine dental prophylaxis into two different

dental environments

GROUP 1- Intellectually disabled Children treated under regular dental environment.

GROUP 2- Intellectually disabled Children treated under sensory adapted dental

environment.

Dental anxiety levels for both the groups, were assessed at baseline, 5 minutes,and at

the end of the procedure using the Venham’s anxiety rating scale, pulse rate and

blood pressure values.

Results: The data was coded and analyzed using software SPSS (IBM version 22.0) for

statistical analysis. Comparison between groups was done using Independent T- test

and repeated measured ANOVA for objective assessment of intergroup and intragroup

anxiety levels respectively, and using Mann Whitney U test and Friedman’s test for

subjective assessment of intergroup and intragroup anxiety levels respectively.

Interpretation and Conclusion: The current study suggests that SADE significantly

decreased anxiety levels and cooperative behaviour in children with mild intellectual

disability and SADE can be used as an alternative behaviour management technique

in effectively handling children with intellectual disability when compared to

conventional behaviour management techniques.

67
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75
Annexures

ANNEXURE 3
INFORMED CONSENT FORM

Bapuji Dental College & Hospital, Davangere, Karnataka

Department of Paedodontics and Preventive Dentistry

Patient name:

Date:

Age in years:

Sex: M/F

Mobile number:

In relation to patient, I hereby confirm that I have been informed in detail about

the procedure of cleaning the teeth of child in two different dental setups. I was

given an opportunity to ask questions and all of them have been answered to my

satisfaction. I therefore give my consent for the procedure to be performed.

Signature of Parent/Guardian

Date and Time

Signature of the doctor in charge

79
Annexures

ಒಪ್ಪಿ ಗೆ ಪತ್ರ

ಬಾಪುಜಿ ದಂತ್ ಕಾಲೇಜು ಮತ್ತು ಆಸ್ಿ ತ್ರರ , ದಾವಣಗೆರೆ, ಕರ್ನಾಟಕ

ಡಿಪಾರ್ಟ್ ಾೆಂಟ್ ಆಫ್ ಪ್ಪಡೊಡೆಂಟಿಕ್ಸ್ ಮತ್ತು ಪ್ಪರ ವೆಂಟಿವ್ ಡೆಂಟಿಸ್ಟ್ರ ರ

ಹೆಸರು: ದಿನಾಂಕ:

ವಯಸ್ಸು :

ಲಾಂಗ:

ಮೊಬೈಲ್ ನಂಬರ:

ರೋಗಿಗೆ ಸಂಬಂಧಿಸಿದಂತೆ, ಎರಡು ವಿಭಿನ್ನ ದಂತ ಚಿಕಿತ್ಸೆ ಯ ಪರಿಸರಗಳಲಿ ಮಗುವಿನ್

ಹಲ್ಲಿ ಗಳನ್ನನ

ಸವ ಚ್ಛ ಗೊಳಿಸ್ಸವ ವಿಧಾನ್ದ ಬಗೆೆ ನ್ನ್ಗೆ ವಿವರವಾಗಿ ತಿಳಿಸಲಾಗಿದೆ ಎಾಂದು ನನ್ನ ಈ

ಮೂಲಕ ಒಪ್ಪಿ ಗೆ ವಯ ಕತ ಪಡಿಸ್ಸತೆತ ೋನೆ. ನ್ನ್ಗೆ ಪರ ಶ್ನನ ಗಳನ್ನನ ಕೇಳಲ್ಲ ಅವಕಾಶ ನೋಡಲಾಯಿತು

ಮತುತ ಅವರೆಲಿ ಕ್ಕೂ ನ್ನ್ಗೆ ತೃಪ್ಪತ ಯಿಾಂದ ಉತ್ತ ರಿಸಲಾಗಿದೆ. ಆದದ ರಿಾಂದ ಕಾಯಯವಿಧಾನ್ವನ್ನನ

ನವಯಹಿಸಲ್ಲ ನನ್ನ ನ್ನ್ನ ಒಪ್ಪಿ ಗೆಯನ್ನನ ನೋಡುತೆತ ೋನೆ.

ರೋಗಿಯ /ಪೋಷಕರ / ರಕ್ಷಕರ ಸಹಿ:

ದಿನಾಂಕ ಮತುತ ಸಮಯ:

ಉಸ್ಸತ ವಾರಿ ವೈದಯ ರ ಸಹಿ:

80
Annexure

ANNEXURE 1

ETHICAL COMMITTEE APPROVAL LETTER

76
Annexures

ANNEXURE 4
STUDY PROFORMA

“COMPARATIVE EVALUATION OF SENSORY ADAPTED DENTAL


ENVIRONMENT AND REGULAR DENTAL ENVIRONMENT IN
REDUCING ANXIETY LEVELS IN CHILDREN WITH INTELLECTUAL
DISABILITY”

NAME: OPD

NO:

AGE: years SEX:

M/F

MOBILE NO:

Parameters Regular dental environment Sensory adapted dental environment

Baseline 5 mins At the end Baseline 5 mins At the end

Pulse rate

Systolic blood
pressure

Diastolic
blood
pressure

Venhams
anxiety scale

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Annexures

I] ARMAMENTARIUM FOR SENSORY ADAPTED DENTAL ENVIRONMENT

Figure 1: HEAD LAMP

Figure 2: SLOW MOVING COLOURED LIGHTS

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Annexures

Figure 3: PORTABLE SPEAKER

Figure 4: CUSTOMIZED MOUTH MASK

32
Annexures

Figure 5: CAMOUFLAGED INSTRUMENTS

Figure 6: BUTTERFLY WRAP

33
Annexures

II] ARMAMENTARIUM FOR EVALUATION OF ANXIETY LEVELS

Figure 7: DIGITAL SPHYGMOMANOMETER

Figure 8: PULSE OXIMETER DEVICE

34
Annexures

SENSORY ADAPTED DENTAL ENVIRONMENT

Figure 9: Representative photograph showing multisensory environment with coloured lights,


butterfly wrap, and camouflaged instruments
DEVICE

35
Annexures

Figure 10: Representative photograph showing butterfly wrap being wrapped around
child in Sensory Adapted Dental Environment

Figure 11: Representative photograph showing treatment of child in Sensory Adapted Dental
Environment

36
Annexures

III] ARMAMENTARIUM FOR REGULAR DENTAL ENVIRONMENT

Figure 12: SCALERS AND MOUTH MASK

Figure 13: MISCELLANEOUS INSTRUMENTS

37
Annexures

Figure 14: Representative Photograph Showing Treatment Of Child In


Regular Dental Environment

38

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