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Added effect of deep breathing and

diaphragmatic breathing exercise in upper


abdominal surgery patients - A randomised
clinical trial

By:

NIRALI P. MISTRY
M.P.T. Ist YEAR

SYNOPSIS OF DISSERTATION
Submitted to the NITTE DEEMED TO BE UNIVERSITY, Mangaluru,
Karnataka, India
In partial fulfilment of the requirement for the Degree of

MASTERS OF CARDIORESPIRATORY AND


INTENSIVE CARE PHYSIOTHERAPY
UNDER THE GUIDENCE OF

MS. SAUMYA SRIVASTAVAMPT


ASSISTANT PROFESSOR

NITTE INSTITUTE OF PHYSIOTHERAPY


MANGALURU- 575018, KARNATAKA, INDIA

1
NITTE INSTITUTE OF PHYSIOTHERAPY
MANGALURU – 575018,
KARNATAKA
PERFORAMA OF SYNOPSIS FOR MPT DISSERTATION

1. Name of the Candidate and NIRALI P. MISTRY


Address E/25, SAI MILAN CO.HSG.SO.,
EVERSHINE CIRCLE,
VASAI EAST,
THANE,
MAHARASHTRA.

2. Name of the Institution NITTE INSTITUTE OF PHYSIOTHERAPY


MANGALURU – 575018, (KARNATAKA.)

3. Course of Study and Subject MASTERS OF CARDIORESPIRATORY AND


INTENSIVE CARE PHYSIOTHERAPY

4. Date of Admission of the 16 AUGUST 2017


Course

ADDED EFFECT OF DEEP BREATHING AND


5. Title of the Research study: DIAPHRAGMATIC BREATHING EXERCISE
IN UPPER ABDOMINAL SURGERY
PATIENTS - A RANDOMISED CLINICAL
TRIAL

2
CONTENTS
S/N CONTENTS PAGE
NO
1. INTRODUCTION 5

2. HYPOTHESIS 7

3. REVIEW OF LITERATURE 8

4. OBJECTIVE OF THE STUDY 11

5. METERIAL AND METHOD 12

6. RESEARCH DESIGN 13

7. MATERIALS USED 14

8. PROCEDURE 15

9. OUTCOME 16

10. STATISTYCAL ANALYSIS 17

11. LIST OF REFERENCE 18

12. SIGNATURES 21

13. TIME PLAN 22

14. BUDGET SHEET 23

15. INFORMED CONSENT 24

16. ANNEXURE 1 (ASSESSMENT SHEET) 27

17. ANNEXURE 2 (DATA COLLECTION SHEET) 29

18. ANNEXURE 3 (AM-PAC SCALE) 30

3
Abbreviation

1. MAS Major Abdominal Surgery

2. PPC Post- operative pulmonary complication

3. FVC Forced Vital Capacity

4. FEV1 Forced Expiratory Volume at one second

5. PEFR Peak Expiratory Flow Rate

6. COPD Chronic Obstructive Pulmonary Disease

7. WHO World Health Organisation

8. PFT Pulmonary Function Test

9. ACBT Active Cycle of Breathing Technique

10. AD Autogenic Drainage

11. AM-PAC Activity Measure for Post-Acute Care

12. ICU Intensive Care Unit

13. ANOVA Analysis of Variance

4
6. BRIEF RESUME OF THE INTENDED WORK

6.1 INTRODUCTION
0 Surgical removal of mass or masses from the abdomen by the abdominal incision is called as
laparotomy1. Surgeries are performed according to the organ affected, which divides the
incision site into upper abdominal surgeries and lower abdominal surgeries. Earlier open
abdominal surgeries were performed but in recent advances laparoscopic surgeries are
performed by the use of rigid tubes1. Every year around 234 million patients are operated for
abdominal surgery globally which include elective and emergency abdominal surgeries2-3. After
Major Upper Abdominal Surgery (MAS), 35% of the patients experience postoperative
complications. The majority of these are pulmonary complications (atelectasis, pneumonia and
respiratory failure) occur in 9% of all patients after major upper abdominal surgery4. Different
risk factors such a type of anaesthesia used, previous respiratory disorders, use of antibiotics,
etc. contribute for the development of pulmonary complications5.

Post- operative pulmonary complication (PPCs) can be defined as “pulmonary abnormalities


occurring in the post- operative period, producing clinically significant identifiable disease and
dysfunction that adversely affect the clinical course”1. They include atelectasis, pneumonia or
hypoxaemia, secretion6, etc. which will lead to temporary diaphragmatic dysfunction, lack of
lung inflation, altered breathing pattern, reduced inspiratory capacity, reduced total inspiratory
time, retained secretions and leading to high risk of infections7.

Chest physiotherapy has been proved effective in reducing the post- operative pulmonary
complications and also reduces the hospital stay after abdominal surgery8. Different respiratory
interventions have been practiced like the use of deep breathing exercise4, incentive spirometer7,
diaphragmatic breathing10, active cycle of breathing technique, autogenic drainage1, etc.

Diaphragmatic breathing exercise is used to regulate the movement of the diaphragm while
inhalation and exhalation. On comparing from rest, it was observed that during this exercise
there is an increase in the displacement of the abdominal compartment. Therefore, this exercise
improves the chest wall volume and helps is distribution of the air in the segments of the lungs.

5
This will help in inflation of alveoli, improvement in oxygenation, reduce the effort of
breathing, and increase the diaphragmatic excursion.10,11.

Deep breathing exercise is a thoracic expansion exercise mainly emphasis on inspiration.


When the air is inspired deeply it is given a3 second end inspiratory hold before passively
relaxed expiration. This will lead to opening of the collateral ventilation and thus helping to
improve basal ventilation and also helps in clearing of the secretions. Thus, focusing on
increasing the tidal volume of the lower lobes of the lungs and preventing collection of
secretions4,11.

From the reviewed literature, it is proved that post-operative pulmonary complications are
commonly occurring after upper abdominal surgery. Diaphragmatic breathing exercise helps
in regulating the movement of the diaphragm and improves the chest wall volume and helps is
distribution of the air in the segments of the lungs. Deep breathing exercise lead to opening of
the collateral ventilation and thus helping to improve basal ventilation and also helps in
clearing of the secretions. Thus, focusing on increasing the tidal volume of the lower lobes of
the lungs and preventing collection of secretions. If the combined effect of deep breathing and
diaphragmatic breathing exercise is proved to be good than it may yield good results in
reducing the pulmonary complications and decrease the length of stay in hospital for the
patient.

So, since there is dearth of literature on combine effect of diaphragmatic breathing and deep
breathing exercise, this study has been taken up to find out the combine effect of
diaphragmatic breathing and deep breathing exercise on upper abdominal surgery patients.

6
6.2 HYPOTHESIS:

 NULL HYPOTHESIS: There willnot be significant added effect of deep breathing


and diaphragmatic breathing exercise on upper abdominal surgery patients
 ALTERNATE HYPOTHESIS:There will be significant added effect of deep
breathing and diaphragmatic breathing exercise on upper abdominal surgery patients

7
6.3 REVIEW OF LITERATURE:

1. Alaparthi G, et at. did a randomised controlled trial in year 2016, to evaluate the
effect of diaphragmatic breathing exercise and flow and volume oriented incentive
spirometry on pulmonary function and diaphragm execration in patients undergoing
laparoscopic abdominal surgeries, where 260 patients were randomised into 4 groups with
diaphragmatic breathing, flow oriented incentive spirometry and volume oriented spirometry
were given to the 3 groups respectively and the control group was given conservative
treatment. All the patients underwent evaluation of FVC, FEV1, PEFR, and diaphragmatic
excursions with ultrasonography. Results found significant difference in the diaphragmatic
breathing exercise and volume oriented incentive spirometry, thus recommending
diaphragmatic breathing as an intervention for the patients10.

2. Cancelliero-Gaiad K M, et al. conducted a prospective randomized crossover trial in


2014, on respiratory pattern of diaphragmatic breathing and Pilates breathing in COPD
subjects. 15 COPD patients, 15healthy patients performed three types of respiration: natural
breathing (NB), diaphragmatic breathing (DB), and pilates breathing(PB), with the
respiratory pattern being analysed by respiratory inductive plethysmography. The parameters
of time, volume, and thoracoabdominal coordination were evaluated. In conclusion DB
showed positive effects such as increase in lung volumes, respiratory motion, and SpO2 and
reduction in respiratory rate. There were no changes in volume and time measurements
during PB in COPD12.

3. Tripathi S, et al. has done a pilot study in 2017 on deep breathing exercise and its
outcome among patient with abdominal surgery, where 40 participants were recruited in 2
groups (20 each) of experimental group and control group. Deep breathing exercise was
given to experimental group4-6 cycle for 8-10 times in a day. and in control group routine
treatment was given. In results the scores of respiratory rates, volume of the spirometry was
significantly different in experimental group. implementing deep breathing exercise during
pre-operative phase with incentive spirometer was effective in terms of enhancement of lung
capacity and prevention from post-operative complications4.

8
4. Westerdahl E conducted a review on literature on optimal technique for deep
breathing exercise after cardiac surgery in year 2015 stating that there are various methods of
deep breathing but there is no literature about most effective technique. This literature
demonstrates the mechanism of each deep breathings exercise technique13.

5. Miller M R, et al, in his study of standardisation of spirometry in year 2005 he


explained about the spirometry and also evaluated reliability and validity for the same. The
spirometry data file will consist of an American Standard Code for Information Interchange,
comma-delineated file with variable length records14.

6. Mehta V, et al. conducted a review of literature in year 2016 on when pulmonary


function test is available, should we wait for the COPD symptoms to develop. They
reviewed and analysed articles from PubMed, Google Scholar, Index Medicus, WHO Global
Health Library and Scopus, which specifically demonstrated the presence of abnormal PFT
changes in asymptomatic adult smokers and conclude that PFTs should be performed early in
smokers and cessation of smoking should be encouraged to check the increasing incidence of
COPD15.

7. Mohan V, et al. conducted a test-retest reliability study in 2012 on intrarater


reliability of chest expansion using cloth tape measure technique. 120 healthy male and
female volunteers were evaluated on two occasions in different days. The measures consisted
of chest expansion measurement at axilla, fourth intercostals and xiphoid levels. They
concluded that the cloth tape measurement was reliable at all the three different anatomical
landmarks of the chest wall. Therefore, this measurement technique could be used as an
outcome measure for chest expansion in the management of cardiorespiratory conditions16.

9
8. Shinghavi S S, et al. conducted a comparative study in 2017 on Effects of active cycle
of breathing technique and autogenic drainage in patient with abdominal surgery. 30
participants who underwent abdominal surgeries with age 25-65 years were divided into two
groups. Group A was given ACBT and Group B was given AD for 1 week of intervention.
Outcome was taken by using inch tape at 3 levels process, incentive spirometer and peak
flow meter. Resultsshowed significant difference when post values of group A and group B
were compared. This study concluded that ACBT is more effective than AD for improving
chest expansion1.

9. Jette D U, et al. conducted a retrospective measurement study in 2014 of Validity of


the AM-PAC “6-Clicks” Inpatient Daily Activity and Basic Mobility Short Forms. The study
used a database from one health system containing “6-Clicks” scores from first and last
physical therapist and occupational therapist visits for 84,446 patients. Validity was analysed
and provided evidence for the validity of “6-Clicks” scores for assessing patients’ activity
limitations in acute care settings17.

10
6.4 OBJECTIVE OF THE STUDY:

The objective of the present study is


 To evaluate the effect of deep breathing exercise on upper abdominal surgery
patients
 To evaluate the effect of diaphragmatic breathing exercise on upper abdominal
surgery patients
 To evaluate the added effect of deep breathing and diaphragmatic breathing exercise
on upper abdominal surgery patients.

11
7. MATERIALS AND METHOD:

7.1 SOURCE OF DATA:


 Department of Surgery, Justice K S Hegde charitable hospital
7.2 METHOD OF COLLECTION OF DATA:
 STUDY DESIGN: A Randomised clinical trial
 STUDY TYPE: An Experimental study
 TARGET POPULATION: All the Upper Abdomen surgery patients
 DURATION OF STUDY: 12 months
 SAMPLING DESIGN: Non-Probability Sampling
 SAMPLING TECHNIQUE: Purposive Sampling
 SAMPLE ALLOCATION: Sub Group of A, Sub Group B and Sub Group C will be
done according to the randomised opaque sealed method.

 SAMPLE SIZE: Using ANOVA test:

α = 5%, power = 80%, Z1 – α/2 = 1.96, Z1 – β = 0.84

Sp = standard deviation

µd = difference
2
2𝑆𝑝2 [𝑍 𝛼 ]
1− + 𝑍1−𝛽
2
n= = 60
𝜇𝑑2

Anticipated dropout rate: 15% = 9

SAMPLE SIZE: 69 subjects

12
 RESEARCH DESIGN:
Assessed for eligibility (n= )
`
Enrollment

Excluded (n= )
Not meeting inclusion criteria (n= )
Declined to participate (n= )
Other reasons (n= )
Randomized (n= )

Allocation

Allocated to deep Allocated to Allocated to deep breathing


breathing exercise diaphragmatic breathing and diaphragmatic breathing
group (n= ) exercise group (n= ) exercise group (n= )

Follow-Up

Lost to follow-up (give reasons) (n= ) Lost to follow-up (give reasons) (n= )
Discontinued intervention (give reasons) Discontinued intervention (give reasons)
(n= ) (n= )

Lost to follow-up (give reasons) (n= )


Discontinued intervention (give reasons) (n= )

Analysis

Analysed (n= ) Analysed (n= )


Excluded from analysis (give reasons) (n= Excluded from analysis (give reasons) (n=
) )

Analysed (n= )
Excluded from analysis (give reasons) (n=
)

13
 MATERIALS USED:
1. Assessment sheet
2. Data collection sheet
3. Informed consent
4. Pulmonary function test instrument (laptop)
5. Inch tape
6. Stethoscope
7. Sphygmomanometer
8. Pulse oximeter
9. Weighting machine
10. Paper
11. Pen
 INCLUSION CRITERIA:

1. Both the gender with the age above 18 years of age

2. Any upper abdominal surgery

3. Visual analogue pain scale score <5

4. No previous history of cardiac and pulmonary complications

5. Non-obese individual (body mass index > 27 kg/m2)

6. Patients willing to participate.

 EXCLUSION CRITERIA:
1. Patients with hemodynamic instability

2. Patient who required ICU care for more than 48 hours

3. It excluded patients undergoing lower abdominal surgeries

4. Patients with cognitive impairments and uncooperative patients or patients unable

to understand

5. Patients who had undergone laparoscopic obstetrics and gynaecological surgery.

6. Patients with postoperative complications requiring mechanical ventilation

14
 Procedure:
After getting the ethical clearance, patient will be approached who will meet the inclusion
criteria. Patients will be explained the purpose of the study and inform consent will be taken from
them. After screening, eligible patients are allocated to group A, group B and group C using
block randomization, opaque sealed envelope method. After allotting them to the groups, base
line assessment of pulmonary function test values, chest expansion and AM-PAC “6-clicks” scale
will be taken by a blinded assessor. Than the group A will be given deep breathing exercise
followed with early mobilization exercise. Group B will be given diaphragmatic breathing
exercise followed with early mobilization exercises. Group C will be given deep breathing and
diaphragmatic breathing exercises followed by early mobilization exercises. Early mobilization
exercise includes ankle toe movements, heel slides, bed side sitting, ambulation and stair
climbing10. Each group will be given breathing exercise for about 4-6 cycles per hourly for 8
waking hours4. For 7 days till the discharge. In all the three groups, early mobilization exercises
will be standardised. After intervention on the day of discharge (i.e. day 7) patients will be
evaluated again and values for pulmonary function test, chest expansion and AM-PAC “6-clicks”
scale will be obtained by a blinded assessor.

Breathing exercise (standard operating procedure):


 Diaphragmatic breathing exercise: patient in half lying position with head and neck
fully supported and abdomen relaxed. Relaxed abdomen can further be obtained by
flexing the knees. Than the therapist will keep both the hands on the lower ribs and the
abdominal wall of the patient. The patient is instructed to first breath out and relax than
breath in with the air entering inside lungs patient is asked to feel the thorax and abdomen
bulging up and then relaxing and passively breathing out10,11.
 Deep breathing exercise: In Deep Breathing subjects were asked to breathe in deeply and
slowly through the nose and sigh out through the mouth. Breathing through nose warms
and humidifies air but doubles resistance to air flow. Inspiration is slow to decrease
velocity and increase the strength of muscle contraction. Expiration is through the mouth
to keep the airway open patency of small airway closure4,11.

15
Outcome:

1. Pulmonary function test: It is a test designed to measure how well the lungs are
expanding and contracting and measures the efficiency of the exchange of oxygen
and carbon dioxide between the blood and air in the lungs. It measures the values like
forced vital capacity (FVC) and forced expiratory volume at one second (FEV1)14.

2. Chest expansion measurement: It is a method used to measure chest expansion using


and inch tape method. It will be measured with inch tape at three different levels of
the chest. For upper lobe at axillary region, for middle lobe at 4th intercostal and at
xiphoid process of the sternum for the lower lobe16.

3. Activity Measure for Post-Acute Care (AM-PAC) “6-Clicks”Inpatient Daily Activity


and Basic Mobility Short Forms: This scale has 2 short forms
 AM-PAC “6-clicks” Inpatient Daily Activity Short Form
 AM-PAC “6-clicks” Inpatient Basic Mobility Short Forms.
The AM-PAC short forms measures 2 functional domains that is basic mobility, daily
activities. It assesses the activity limitations of patients with a wide variety of
medical and surgical conditions in an acute care setting17.

16
Statistical Analysis:
To summarize outcome measures (pulmonary function test, chest expansion with measure
tape and AM-PAC “6-clicks” Inpatient Daily Activity and Basic Mobility Short Forms)
mean and standard deviation will be used (descriptive analysis) to compare the effectiveness
between the 3 groups by one way ANOVA if the data follows normal distribution and Karl
Pearson test will be used if the data do not follow normal distribution. Level of significance
p = <0.05.

Outcome measures will be analysed using SPSS software version 16.

7.3 Does the study require any interventions or investigations to be conducted on


patients or other human or animals? If so, please describe briefly.

Yes, the study includes breathing exercises which will be performed by the patients.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Will be Obtained

17
8. LIST OF REFRENCES:

1. Shingavi S, Kazi A, Gunjal S, Lamuvel M. Effects of Active Cycle of Breathing Technique


and Autogenic Drainage in Patient with Abdominal Surgery. International Journal of Applied
Research. 2017;3(2):373-376.

2. Bhasin S, Roy R, Agrawal S, Sharma R. An Epidemiological Study of Major Surgical


Procedures in an Urban Population of East Delhi. Indian Journal of Surgery. 2010;73(2):131-
135.

3. Patel K, Hadian F, Ali A, Broadley G, Evans K, Horder C, et al. Postoperative pulmonary


complications following major elective abdominal surgery: a cohort study. Perioperative
Medicine. 2016;5(1).

4. Tripathi S, Sharma R. Deep Breathing Exercise and its Outcome among Patient with
Abdominal Surgery: A Pilot Study. International Journal of Nursing Science. 2017;7(5):103-
106.

5. Kodra N, Shpata V, Ohri I. Risk Factors for Postoperative Pulmonary Complications after
Abdominal Surgery. Open Access Macedonian Journal of Medical Sciences. 2016;4(2):259.

6. Pasquina P, Tramér M, Granier J, Walder B. Respiratory Physiotherapy To Prevent


Pulmonary Complications After Abdominal Surgery. Chest. 2006;130(6):1887-1899.

7. Dias CM, Placido TR, Ferreria MF,Guimarães FS, Menezes SLS. Incentive Spirometry and
Breath Staking: Effects on the Inspiratory Capacity of Individuals Submitted to Abdominal
Surgery. Rev Bras Fisioter, São Carlos. 2008;12(2):94-99.

8. Manzano R, Carvalho C, Saraiva-Romanholo B, Vieira J. Chest physiotherapy during


immediate postoperative period among patients undergoing upper abdominal surgery:
randomized clinical trial. Sao Paulo Medical Journal. 2008;126(5):269-273.

9. Grams S, Ono L, Noronha M, Schivinski C, Paulin E. Breathing exercises in upper


abdominal surgery: a systematic review and meta-analysis. Brazilian Journal of Physical
Therapy. 2012;16(5):345-353.

10. Alaparthi G, Augustine A, Anand R, Mahale A. Comparison of Diaphragmatic Breathing


Exercise, Volume and Flow Incentive Spirometry, on Diaphragm Excursion and Pulmonary

18
Function in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Trial.
Minimally Invasive Surgery. 2016;1-12.

11. Solomen S, Aaron P. Breathing techniques- A review. International Journal of Physical


Education, Sports and Health. 2015;2(2):237-241.

12. Cancelliero-Gaiad K M, Ike D, Pantoni B F, Borghi-Silva A, Costa D. Respiratory Pattern


of Diaphragmatic Breathing and Pilates breathing in COPD subjects. Brazillian Journal of
Physical Therap. 2014;18(4):291-299.

13. Westerdahl E. Optimal technique for deep breathing exercises after cardiac
surgery.Minerva Anestesiol. 2015;81:678-683.
14. Miller M, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, et al.
Standardisation of spirometry. European Respiratory Journal. 2005;26(2):319-338.
15. Mehta V, Desai N, Patel S. When Pulmonary Function Test is available, Should we Wait
for the COPD Symptoms to Develop?. Journal of Clinical and Diagnostic Research.
2016;10(10):OE08-OE12.
16. Mohan V, Dzulkifli N, Justine M, Haron R, H LJ, Rathinam C. Intrarater Reliability of
Chest Expansion using Cloth Tape Measure Technique. Bangladesh Journal of Medical
Science. 2012;11(4).

17. Jette D, Stilphen M, Ranganathan V, Passek SD, Frost FS, Jette AM. Validity of the AM-
PAC "6-Clicks" Inpatient Daily Activity and Basic Mobility Short Forms. Physical Therapy.
2013;94(3):379-391.

18. Tadyanemhandu C, Mukombachoto R, Nhunzvi C, Kaseke F, Chikwasha V, Chengetanai


S, et al. The prevalence of pulmonary complications after thoracic and abdominal surgery and
associated risk factors in patients admitted at a government hospital in Harare, Zimbabwe-a
retrospective study. Perioperative Medicine. 2017;6(1).

19. Zhang X, Wang Q, Zhang S, Tan W, Wang Z, Li J. The use of a modified, oscillating
positive expiratory pressure device reduced fever and length of hospital stay in patients after
thoracic and upper abdominal surgery: a randomised trial. Journal of Physiotherapy.
2015;61(1):16-20

19
20. Souza Possa S, Braga Amador C, Meira Costa A, Takahama Sakamoto E, Seiko Kondo C,
Maida Vasconcellos AL, et al. Implementation of a guideline for physical therapy in the
postoperative period of upper abdominal surgery reduces the incidence of atelectasis and
length of hospital stay. Revista Portuguesa de Pneumologia. 2014;20(2):69-77.

21. Thomas J, McIntosh J. Are Incentive Spirometry, Intermittent Positive Pressure Breathing,
and Deep Breathing Exercises Effective in the Prevention of Postoperative Pulmonary
Complications After Upper Abdominal Surgery? A Systematic Overview and Meta-analysis.
Physical Therapy. 1994;74(1):3-10

22. do Nascimento P, Módolo N, Andrade S, Guimaraes MMF, Braz LG, Dib RE. Incentive
spirometry for prevention of postoperative pulmonary complications in upper abdominal
surgery. European Journal of Anaesthesiology. 2014;31:79.

23. Mackay M, Ellis E, Johnston C. Randomised clinical trial of physiotherapy after open
abdominal surgery in high risk patients. Australian Journal of Physiotherapy. 2005;51(3):151-
159.

24. Patman S, Bartley A, Ferraz A, Bunting C. Physiotherapy in upper abdominal surgery –


what is current practice in Australia?. Archives of Physiotherapy. 2017;7(1).

25. Davies S, Francis J, Dilley J, Wilson JT, Howell SJ, Allgar V. Measuring outcomes after
major abdominal surgery during hospitalization: reliability and validity of the Postoperative
Morbidity Survey. Perioperative Medicine. 2013;2(1):1.

26. Ireland C, Chapman T, Mathew S, Harbison GP, Zacharias M. Continuous positive airway
pressure (CPAP) during the postoperative period for prevention of postoperative morbidity and
mortality following major abdominal surgery. Cochrane Database of Systematic Reviews.
2014.

27. Yaglioglu H, Koksal G, Erbabacan E, Ekici B. Comparison and Evaluation of the Effects
of Administration of Postoperative Non-Invasive Mechanical Ventilation Methods (CPAP and
BIPAP) on Respiratory Mechanics and Gas Exchange in Patients Undergoing Abdominal
Surgery. Turkish Journal of Anesthesia and Reanimation. 2015;43(4):253-252.

20
9. NIRALI P. MISTRY
Signature of the candidate

10. Remark of the guide

MRS. SAUMYA SRIVASTAVA MPT


11. 11.1 Name and Designation of ASSISTANT PROFESSOR
Nitte Institute of Physiotherapy
Guide Mangalore

11.2 Signature

MRS. SUDINI S. SINAI BORKAR MPT


ASSISTANT PROFESSOR
11.3 MPT Co-Ordinator
Nitte Institute of Physiotherapy
Mangalore

11.4 Signature

DR. DHANESH KUMAR K U MPT, PHD


PRINCIPAL AND PROFESSOR
11.5 Principal
Nitte Institute of Physiotherapy
Mangalore

11.6 Signature

21
12. TIME PLAN

PHASES TIME PERIOD OUTLINE OF PLAN

Nov 2017- May i) Identification of


PHASE I 2018
the Problem
ii) Review of
literature
iii) Development of
Performa
iv) Submission of
Synopsis
v) Ethical clearance

May 2018- Dec i) Enrolment


PHASE II 2018
ii) Data collection
Jan 2019 i) Analysis of
PHASE III
collected data
ii) Discussion

Feb 2019 Submission of project report


PHASE IV
and article

22
13. BUDGET SHEET

S.N. PARTICULARS RUPEES

1. Consent form 1000

 Consent forms, Data collection sheet

Patient assessment forms

2. Instruments 500

3. Preparation of dissertations 5000

4. Expenditure in travels 500

5. Miscellaneous

Total 7000

23
NITTE INSTITUTE OF PHYSIOTHERAPY
INFORMED CONSENT

TITLE: ADDED EFFECT OF DEEP BREATHING AND DIAPHRAGMATIC BREATHING


EXERCISE ON UPPER ABDOMINAL SURGERY PATIENT: A RANDOMISED CLINICAL
TRIAL
PURPOSE OF STUDY: The study aims to find the combine effect of deep breathing and
diaphragmatic breathing exercise in upper abdominal surgery patients.

PROCEDURE: You will be recruited in the study only if you fulfil the inclusion criteria. You
will be explained about the procedure and its effect before the commencement of the study.
You will have to perform breathing exercise along with some mobilization exercise every hour
for 15 min for 8 hours in a day, for 7 days. You will be evaluated after the treatment on 7th day.
The health care that is provided to you by the physiotherapist will remain the same regardless of
whether you are included in study or not.

RISKS: There is no risk as a result of participation in this study.

BENEFITS: The breathing exercise will help you to minimize the problem developed after the
surgery to you and also help in better and faster recovery.

PRIVACY AND CONFIDENTIALITY: Privacy and confidentiality of the information you


provide will be safeguarded for subject to any legal requirement.

FINANCIAL INCENTIVE FOR PARTICIPATION: You will not receive any financial
assistance for participating in this study.

ALTERNATIVES: If you decide to participate in the study, you will be benefited by the
program. If you decide not to participate in the study and/ or even wish to drop out any time
during the study, the conventional physiotherapy will be given to you.

AUTHORIZATION TO PUBLISH RESULTS: Results of this study may be published for


scientific purpose and / or presented to scientific groups; however, you will not be identified.
SPONSORS POLICY: Nitte Institute of Physiotherapy, Mangalore sponsorsthis study project
in which you are participating.
INSTITUTIONAL POLICY: Nitte Institute of Physiotherapy, Mangalore will provide, within
the limitation of the laws of the State of Karnataka, facilities and medical attention to subjects
who suffer injuries as a result of participating in its projects.

24
In the event, you believe that you have suffered any physical injury as the result of your
participation in this study, you may contact Principal investigators, Head guide, Telephone no
9740244077.
VOLUNTARY PARTICIPATION AND AUTHORIZATION:Your participation in this study
is voluntary. Your decision whether or not to participate in the study will not affect your care
during your hospital admission. You are free to discontinue participation in this study at any time
and for any reason. In case, you need any further information regarding your rights as study
participant you may please contact Principal, Nitte Institute of physiotherapy, Mangalore
Telephone no

25
STATEMENT OF CONSENT:

I, Mrs. ________________________________________ volunteer and consent to participate in


this study. The contents of the study have been fully read and explained to me in the vernacular
language and the same is true and correct to the best of my knowledge, information and belief. I
may ask question at any time during the study.

__________________________ _________________________
Name of the subject Signature/left thumb impression

___________________________ __________________________
Name of the witness Signature/left thumb impression

______________________ _______________________
Signature of Investigators Signature of Guide
NIRALI P. MISTRY MRS. SAUMYA SRIVASTAVA

Date :
Place:

26
ANNEXURE 1:
ASSESSMENT SHEET

Date: Subject no:

Name:_____________________________________________________________

Age:________ Gender: _________________ IPD no: _____________

Occupation: ________________________

Height: ___________ cm Weight: ______________kg BMI: ___________kg/m2

Address and contact no: _____________________________________________


_________________________________________________________________
_________________________________________________________________

Date of Surgery: ________________

Type of Surgery: _________________________________________

Any previous History of:


 Pulmonary conditions: Yes: No:

 Cardiac conditions: Yes: No:

If yes than give reason: __________________________________________________________

27
Pain Assessment:

Visual analogue scale:

No pain Moderate pain Sever pain

Vitals:
Blood Pressure: ____________mm/Hg
Respiratory Rate: ___________b/m
Heart Rate: ___________b/m
Temperature: ____________◦C/◦F
Saturation: _____________ %

Group: A B C

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ANNEXURE 2
DATA COLLECTION SHEET

Outcome Measures pre-test value Post-test value


Pulmonary function test
1. FVC
2. FEV1
Chest expansion
1. At axilla
2. At nipple
3. At xiphisternum
AM-PAC “6-clicks” score
Inpatient Daily Activity
Short Form score
Inpatient Basic Mobility
Short Forms score

__________________________ _________________________
Name of the subject Signature/left thumb impression

______________________ _______________________
Signature of Investigators Signature of Guide
NIRALI MISTRY MRS. SAUMYA SRIVASTAVA

29
ANNEXURE 3:

AM-PAC SCALE

“6-Clicks” Inpatient Basic Mobility Short Form

Please check the box that reflects your (the Unable A Lot A Little None
patient’s) best answer to each question.
How much difficulty does the patient 1 2 3 4
currently have . . . .
1. Turning over in bed (including adjusting 1 2 3 4
bedclothes, sheets, and blankets)?
2. Sitting down on and standing up from a 1 2 3 4
chair with arms (e.g., wheelchair, bedside
commode)?
3. Moving from lying on back to sitting on the 1 2 3 4
side of the bed?
How much help from another person does 1 2 3 4
the patient currently need . . .
4. Moving to and from a bed to a chair 1 2 3 4
(including a wheelchair)?
5. To walk in hospital room? 1 2 3 4

6. Climbing 3–5 steps with a railing? 1 2 3 4

Clinicians may find the following helpful in selecting responses:


1. Total/Unable = Total/Dependent Assist
2. A Lot = Maximum/Moderate Assist
3. A Little = Minimum/Contact Guard Assist/Supervision
4. None = Modified Independence/Independent

30
“6-Clicks” Inpatient Daily Activity Short Form

Please check the box that reflects your Unable A Lot A Little None
(the patient’s) best answer to each
question.
How much help from another person 1 2 3 4
does the patient currently need . . .
1. Putting on and taking off regular lower 1 2 3 4
body clothing?
2. Bathing (including washing, rinsing, 1 2 3 4
drying)?
3. Toileting, which includes using toilet, 1 2 3 4
bedpan, or urinal?
4. Putting on and taking off regular upper 1 2 3 4
body clothing?

5. Taking care of personal grooming such 1 2 3 4


as brushing teeth?
6. Eating meals? 1 2 3 4

Clinicians may find the following helpful in selecting responses:


1. Unable = Total/Dependent Assist
2. A Lot = Maximum/Moderate Assist
3. A Little = Minimum/Contact Guard Assist/Supervision
4. None = Modified Independence/Independent

31

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