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Physiology & Behavior 211 (2019) 112676

Contents lists available at ScienceDirect

Physiology & Behavior


journal homepage: www.elsevier.com/locate/physbeh

Influence of lavender oil inhalation on vital signs and anxiety: A randomized T


clinical trial

Nazife Begüm Karan
Recep Tayyip Erdoğan University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Rize, Turkey

A R T I C LE I N FO A B S T R A C T

Keywords: Objective: To investigate the effectiveness of lavender oil (Lavandula angustifolia Mill) inhalation on anxiety,
Anxiety mood, and vital signs (blood pressure, respiratory rate, heart rate, and saturation) of patients undergoing oral
Clinical trial surgery. Vital signs were considered as primary outcome measures. Paired anxiety tests were used as secondary
Inhalation outcome measures.
Lavender
Methods: Patients who had dental anxiety according to the Dental Anxiety Questionnaire (DAQ) were enrolled in
Oral surgery
the study. One hundred twenty-six patients who were undergoing wisdom tooth removal under local anaesthesia
Wisdom tooth
were randomly assigned to the lavender oil and control groups. Paired anxiety tests (Modified Dental Anxiety
Scale and State-Trait Anxiety Inventory–State Scale were performed. Vital signs were noted pre-, intra-, and post-
operatively. Visual analogue scale (VAS) results were assessed. The patients' degree of satisfaction was noted.
Results: Pre-operative anxiety levels were similar in both groups. Significant changes in blood pressure were
observed in the lavender oil group post-operatively (p < .05). Most (79.4%) of the patients in the lavender oil
group enjoyed the scent, 89.68% were satisfied with their experience, and 97.62% of the patients stated that
they would prefer the same protocol when needed.
Conclusion: Inhalation of lavender oil, which is one of the most powerful anxiolytic essential oils, reduces peri-
operative anxiety and can be prospectively considered in future studies for its potential sedative characteristics
in patients undergoing surgical procedures under local anaesthesia.
Trial registration number:NCT03722771 (Influence of Lavender Oil on Vital Signs in Oral Surgery Patients)
https://clinicaltrials.gov/ct2/show/NCT03722771

1. Introduction used in folk medicine since ancient times. Lavender oil has also been
used as an anti-inflammatory, antiseptic, mucolytic, and carminative
Dental anxiety is one of the most common global obstacles to dental phytotherapeutic agent for the treatment of minor health problems
care, especially for patients who need oral surgery [1,2]. This prevents [9,10].
patients from visiting dental offices and leads to further health pro- Lavenders are mostly native to the Mediterranean region and
blems [3,4]. Southern Europe. > 30 species of lavenders are known and used in
There are many products with sedative effects used in patients with cosmetics, the food industry or as scents [9–11]. The sedative properties
anxiety prior to surgery. General anaesthesia or sedation may be re- of this oil have been demonstrated widely on animals [12–16]. One of
commended for patients with dental fear; however, it should be borne the components in lavender oil, linalool, was found to have an in-
in mind that these procedures may carry some risks. Additionally, some hibitory effect on the limbic system and autonomic neurotransmission,
patients have allergies or other contraindications for general anaes- which ultimately lead to a drop in blood pressure [14]. This systemic
thesia. Aromatherapy is a preferred option for patients with anxiety effect is associated with gamma-aminobutyric acid (GABA-A) receptors,
who are scheduled to undergo surgical procedures under local anaes- which are known to play an important role in reducing anxiety levels
thesia [5–8]. [12,15,17]. Lavender oil is known to be one of the most effective es-
Several aromatherapy oils have been used for centuries for curing sential oils for relieving anxiety disorders, and it is regarded as an ac-
various diseases. Lavender oil is one of the most effective and most cessible and safe option compared with anti-psychotic medications (e.g.
preferred oils. Extracts derived from the genus of lavender have been alprazolam, lorazepam, and diazepam) [5–8,10,13,18]. It has been


Corresponding author.
E-mail address: nazifebegum.karan@erdogan.edu.tr.

https://doi.org/10.1016/j.physbeh.2019.112676
Received 20 June 2019; Received in revised form 15 August 2019; Accepted 5 September 2019
Available online 07 September 2019
0031-9384/ © 2019 Elsevier Inc. All rights reserved.
N.B. Karan Physiology & Behavior 211 (2019) 112676

shown to have effects similar to lorazepam in anxiety disorders, which question test with a total score of 5 to 25. STAI-S measures an in-
has been used as a licensed treatment protocol in recent years [19,20]. dividual's immediate response to a threatening situation, and designates
Oral surgical procedures have been proven to be the greatest con- the current anxiety [5,25]. The STAI-S consists of 20 items and scores
cern among dental practices for patients [21,22]. To the best of our range from 1 (almost never) to 4 (almost always) [26].
knowledge, limited randomized clinical trials have demonstrated evi- Pain intensity was measured using a Visual Analogue Scale (VAS) in
dence-based results of lavender oil, despite being the most effective both groups. VAS scores range from 0 (no pain) to 10 (unbearable pain).
essential oil for anxiety and stress. A reduction of blood pressure with Patients in the lavender oil group were also asked to complete the two-
the scent of lavender or linalool has been shown in studies; however, no item Satisfaction Questionnaire Test. The first question asked patients to
studies have demonstrated its effects on vital signs during an entire identify their experiences ranging from 1 (low satisfaction) to 5 (high
stressful intervention. satisfaction). The second question determined if they would prefer the
In both dentistry and medicine, it is necessary to prevent anxiety in same protocol (yes or no) when needed.
order to comfortably treat patients. Empathy with the patient, the right
approach, and alternative therapies enable smart use of anxiolytic 2.3. Randomization of the groups
drugs, reserving sedation and general anaesthesia for serious condi-
tions. A patient's anxiety poses major management problems for the A simple randomization was performed by a nurse by which pa-
dental team because more treatment time will be required for an an- tients were randomly assigned to the groups according to the last digit
xious patient who is very likely to miss appointments. The hypothesis of of their hospital number. The numbers are issued by the hospital and
the present study was that the inhalation of lavender oil prior to oral the last digit can be even or odd. Even numbers were assigned to the
surgical procedures would reduce anxiety and affect intra and post- lavender oil (experimental) group and odd numbers were assigned to
operative vital signs (blood pressure, respiratory rate, heart rate, and the control group. Patients in the experimental group inhaled 100%
saturation). pure, high-strength lavender oil in a separate room for 3 min prior to
surgery. Med patches were used for the inhalation protocol and skin
2. Material and methods contact was avoided. The control group was allowed no lavender ex-
posure.
A randomized controlled clinical trial providing lavender oil as an
inhalation agent was conducted in the Oral & Maxillofacial Surgery
2.4. Aromatic oil used in the study
Department of XXX University. Power analysis was performed using the
G-Power software package to predict the number of patients (80.4%
The natural essential oil of lavender (100% pure Lavandula angusti-
power, two-sided 5% significance level) and a previous study was used
folia Mill. NU13950, lot number 9133, Code APE 7490B), which is
to calculate the sample size [23]. It was determined that at least 63
marketed for clinical use, was obtained from NU-KA Defne Essencia
patients (126 in total) were required in each group (α = 0.05, 91.4%
(Antalya, TURKEY). The country of origin of the lavender herb used
power). Vital signs were considered as primary outcome measures.
was France.
Anxiety test results served as secondary outcome measures. Those who
were involved in the conduct and analysis of the results of the study
were blinded to group allocation. 2.5. Anxiety monitoring
The protocol of the present study was approved by the Ethics
Committee of XXX University (Approval No.: 2016/87, Protocol Nurses checked and recorded the vital signs (blood pressure, re-
No.:106). spiratory rate, heart rate, and saturation) during the course the inter-
ventions. The level of the vital signs was noted pre-operatively, im-
2.1. Recruitment and exclusion criteria mediately after the maximum pressure applied to elevate the wisdom
tooth, and post-operatively. The surgical duration was also noted.
Patients with a baseline Dental Anxiety Questionnaire (DAQ) score of
at least 2 were enrolled in the study. One hundred twenty-six patients 2.6. Statistical analyses
who were systemically healthy according to the American Society of
Anaesthesiologists (ASA) classification (ASA I), aged 18 to 37 years The data obtained in the present study were analysed using the IBM
were recruited between September and December 2017. Patients aged SPSS Statistics for Windows software (Version 20 IBM Corp, Armonk,
under 18 years, those taking psychotropic medication or psychiatric NY, USA). The Kolmogorov–Smirnov test was used to determine the
treatment, those with systemic health problems or allergies, and preg- normality of the distribution. The distributions of all scales were con-
nant women were excluded. All patients were informed about the sidered significant at levels of p < .05.
procedure of wisdom tooth extraction in a separate room prior to sur- The Chi-square test was used to evaluate the differences in socio-
gery. Written informed consent was obtained for the described protocol. cultural variables and the effects of previous oral surgical history
This protocol allowed patients to drop out of the study at any stage (Table 1). Differences in pain level were evaluated using the Man-
without having to provide any explanation. n–Whitney U test. The duration of the procedures in both groups was
also assessed using the Mann–Whitney U test (Table 2).
2.2. Paired anxiety tests and other scales Correlations among the three anxiety measures (DAQ, MDAS, and
STAI-S) were assessed using the Pearson product-moment correlation
The DAQ, Modified Dental Anxiety Scale (MDAS), State-Trait Anxiety coefficient.
Inventory–State Scale (STAI-S) tests were used pre-and post-operatively Differences between paired tests (STAI-S, MDAS) were analysed
in the anxiety survey. The DAQ test is a single-item measure that asks using the Wilcoxon and Mann–Whitney U tests, both within and across
patients if they are anxious about going to the dentist. DAQ has 4 all groups (Table 3).
grades, 1–4 (1-No; 2- slight; 3-Yes; 4-Yes, a lot). [24] Higher values Friedman's two-way analysis of variance (ANOVA) test was used to
indicate higher anxiety for all used tests. analyse differences in vital signs at different time intervals (Table 4).
The MDAS and STAI-S tests are the most commonly used measures Additionally, differences between the groups were analysed using the
to evaluate mood and dental anxiety. MDAS evaluates the level of an- Mann–Whitney U test. In the presence of a significant difference, in-
xiety that may arise against dental practice; therefore, the questionnaire tergroup comparisons (post hoc analysis) were made using Bonferroni
reflects the views of patients about their future concerns. It is a 5- correction.

2
N.B. Karan Physiology & Behavior 211 (2019) 112676

Table 1 3. Results
Differences in personal details.
Variable Control group Lavender oil Total p value No enrolled participants dropped out of the study. The demographic
% (n) group % (n) features of the patients (126 in total) showed no significant differences
% (n) between the groups. All selected patients were similar in age, height,
weight, and socio-cultural variables. Seventy-six per cent of the parti-
Sex (F/M) 79/21 (50/ 73/27 (46/17) 76/24 (96/ 0.530
13) 30)
cipants were females. Forty-four per cent of the patients had graduated
Educational level 0.490 from high school and 38% were university graduates. Of all patients in
Literate 3 (2) 5 (3) 4 (5) both groups, 62% had no history of wisdom tooth extraction (Table 1).
Elementary 3 (2) 0 (0) 1 (2) There were no statistically significant differences between the two
Middle school 15 (9) 11 (7) 13 (16)
groups in terms of pain levels. The differences between the durations of
High school 38 (24) 49 (31) 44 (55)
University 41 (26) 35 (22) 38 (48) the procedures were also statistically insignificant (Table 2).
Income 0.192 Statistical analysis showed a high degree of correlation among the
(Turkish Lira)⁎ anxiety questionnaires (DAQ, MDAS, STAI-S) for the assessment of the
< 1000 17 (7) 11 (11) 14 (18)
patients' stress levels. All patients showed moderate anxiety levels in all
1000–2500 67 (36) 57 (42) 62 (78)
2500–5000 13 (17) 27 (8) 20 (25)
tests applied both before and after the surgical procedures. According to
> 5000 3 (3) 5 (2) 4 (5) the paired test (MDAS, STAI-S) comparisons, there was no statistically
Place of residence 0.267 significant difference between the groups in terms of initial and final
City 45 (34) 54 (28) 49 (62) anxiety levels when analysed using the Mann–Whitney U test. However,
County 30 (20) 32 (19) 31 (39)
post-operative results showed a significant decrease compared with pre-
Village 25 (9) 14 (16) 20 (25)
Health Insurance 0 (4) 6 (0) 3 (4) 0.080 operative results when the groups were assessed within themselves
None using the Wilcoxon test. Nevertheless, a statistically insignificant de-
Social security 97 (54) 86 (61) 91 (115) crease in post-operative anxiety levels was detected in the lavender oil
Free medical care 2 (3) 5 (1) 3 (4) group (p < .05) (Table 3).
Private insurance 1 (2) 3 (1) 3 (3)
Previous wisdom
Most (79.4%) of the patients in the lavender oil group enjoyed the
Tooth extraction scent, 89.68% were satisfied with their experience, and 97.62% of the
History patients stated that they would prefer the same protocol when needed.
Very good 2 (6) 10 (1) 5 (7) No adverse effects were detected.
Good 3 (4) 6 (2) 5 (6) 0.267
In-group vital sign evaluations were made using Friedman's two-
Not bad 24 (11) 17 (15) 21 (26)
Bad 8 (3) 5 (5) 6 (8) way ANOVA test. A statistically significant decrease in post-operative
Severe 1 (0) 0 (1) 1 (1) systolic blood pressure was observed in the lavender oil group com-
No history 62 (39) 62 (39) 62 (78) pared with the pre-operative and intra-operative measurements (post
hoc 82% power). A statistically significant decrease in post-operative
Chi square test.
⁎ heart rate was detected in the control group compared with the pre-
10 Turkish Lira = roughly $US 5.60.
operative and intra-operative measurements (p < .05).
n = number of patient. F = female. M = male.
p < .05 = statistically different. Group comparisons were also made using the Mann-Whitney U test
and a significant decrease in intra-operative respiratory rate was found
Table 2 in the lavender oil group. In contrast, a significant increase in intra-
Differences of pain level and operation time between groups. operative respiratory rate was observed in the control group (post hoc
96% power) (p < .05). No other significant differences were observed
Control group Lavender oil group p value
in the between-group comparisons (Table 4).
Mean ± SD Mean ± SD

Degree of pain 1.62 ± 1.83 1.6 ± 2.63 0.212 4. Discussion


Duration of the 16.32 ± 9.51 16.78 ± 9.22 0.641
procedure
According to previous studies, it was determined that demographic
Mann-Whitney U Test.
characteristics such as sex, age, socio-cultural status, and education
SD, Standard deviation. level could affect anxiety levels [3,4]. All demographic characteristics
p < .05, Statistically different. of the patients were similar in the current study. In addition, the
duration of the procedures was similar. Post-operative MDAS and STAI-
Table 3 S results showed a significant decrease in anxiety levels in both groups;
Differences of anxiety scores within groups according to the time of the surveys. however, there was no significant difference between the initial and
final anxiety levels between the groups. Post-operative pain scores were
Questionnaires Pre-operative Post-operative p value
Mean ± SD Mean ± SD
also similar in both groups. These findings may be related to good
doctor-patient communication and the explanation of the procedures
Lavender oil group prior to the operations. It has been shown that MDAS is sensitive for the
MDAS 11.37 ± 4.58 9.98 ± 4.16 0.007⁎ identification of differences in dental anxiety resulting from manip-
STAI 41.16 ± 10,97 33.86 ± 11.03 0.001⁎
Control group
ulations in behavioural interventions [5]. The results of the present
MDAS 11.06 ± 3.66 10.17 ± 3.63 0.006⁎ study support this finding and the reduction of the anxiety levels in
STAI 42.22 ± 9.95 36.71 ± 10.56 0.001⁎ both groups could again be attributed to good care and communications
of all those involved in the procedure.
SD, Standard deviation. In terms of vital signs, however, there were systemic differences
p < .05, Statistically different.
between the control and the experimental groups. The intra- and post-
Wilcoxon Test.
⁎ operative vital signs of the patients were better in the lavender oil
The bold “p-value” indicates significant reduction in post-operative anxiety
levels compared to pre-operative measurements.
group. A statistically significant decrease in post-operative systolic
blood pressure was observed in the lavender group, which was in-
dicative of a decrease on anxiety levels. In addition, the low intra-

3
N.B. Karan Physiology & Behavior 211 (2019) 112676

Table 4
The median (min-max) scores at “vital signs” according to the time of the surveys.
Vital signs Pre-operative Intra-operative Post-operative Chi square p value

Median(min-max) Median(min-max) Median(min-max)

Lavender oil group Blood pressure (systolic) 110 (90–200) 110 (80–180) 105 (80–170) 8.691 0.013⁎
Blood pressure (diastolic) 60 (50–100) 70 (40–100) 60 (50–86) 2 0.368
Pulse/heart rate 89 (53–125) 90 (55–135) 86 (60–116) 4.769 0.092
Respiratory rate per minute 24 (20–36) 24 (16–28)a 24 (16–36) 3.138 0.204
Saturation 99 (96–100) 99 (91–-99) 99 (96–99) 1.14 0.566
Control group Blood pressure (systolic) 110 (80–140) 110 (80–150) 100 (80–140) 4.952 0.084
Blood pressure (diastolic) 60 (40–90) 70 (50–-90) 60 (50–-90) 3.191 0.203
Pulse /heart rate 87 (61–128) 86 (60–130) 86 (57–118) 11.139 0.004⁎⁎
Respiratory rate per minute 24 (20–28) 24 (16–-32)b 24 (20–−32) 5.574 0.062
Saturation 99 (97–99) 99 (90–99) 99 (94–99) 1.505 0.471

p < .05, Statistically different.


Differences within groups were analysed by Friedman's two-way ANOVA test.
Differences between groups were analysed using the Mann-Whitney U test.

The bold “p-value” indicates significant reduction in post-operative systolic blood pressure compared with pre-operative and intra-operative measurements in the
lavender oil group.
⁎⁎
The bold “p-value” indicates a significant reduction in post-operative heart rate compared with the pre-operative and intra-operative measurements in the
control group.
a
Significant decrease in intra-operative respiratory rate was found in the lavender oil group. (p < .05).
b
Significant increase in intra-operative respiratory rate was found in the control group. (p < .05).

operative respiratory rate shows the relaxation of the patients. On the derived from lavender oil, is used as a licensed treatment protocol for
other hand, a significant heart rate drop was found in the control group. anxiety in Germany. In studies, supplements of lavender oil were found
An accelerated heart rate during anxiety is a well-known systemic re- to have positive effects comparable to anxiolytic drugs, as well as
action, but the reason behind the slow heart rate is not very clear. A having fewer adverse effects [19,20]. Similar effects of lavender oil
slow heart rate can cause more distress, which may cause the patient to application were observed in the current study by inhalation.
faint. Anxiety or panic attacks during emotional stress may cause de- Numerous useful (e.g. anti-inflammatory and analgesic) effects of
terioration of the autonomic nervous system. The autonomic nervous lavender oil use have been reported in the literature. However, the
system is in charge of maintaining a regular heart rhythm and normal mechanisms underlying its anxiolytic effects still remain unknown. It is
blood pressure. During times of stress, the nervous system stops its known that volatile molecules of lavender oil diffuse into the blood
influence. Increased blood pressure and stress can cause vagal nerve rapidly after entering the lungs and eventually reach the brain by the
stimulation. As a result, the stimulation of this nerve can reduce the circulation. Brain activation occurs also by olfactory receptors [10,36].
heart rate and, in extreme cases, cause syncope, shock, and asystole Additionally, some studies have shown that lavender oil induces alpha
[27,28]. waves in the cortex, which causes relaxation. Linalool, one of the main
Systolic blood pressure gradually decreased in the lavender group. components of lavender oil, has been proven to reduce beta brain wave
However, in the control group, the pre-operative values increased intra- activity, which has a significant effect on vigilance and awareness [16].
operatively and then decreased. A significant decrease in pulse rate in In recent studies, the anxiolytic effect of linalool was linked to the dose-
combination with blood pressure fluctuation was seen in the control dependent action potential-blockage of sodium channels [37,38]. Other
group, which may create syncope in patients. In contrast, the gradual researchers attributed the underlying neurochemical mechanism of li-
reduction of the blood pressure and the steady-state monitoring of the nalool to the inhibitory effect on glutamate binding in central nervous
pulse in the lavender oil group allows the patient to be treated more system membranes [38,39]. However, sustained stimulation causes ig-
comfortably. As a result of the current study, due to the positive norance in the central nervous system and eventually becomes no
(calming) effects of lavender oil inhalation, we may suggest that it can longer responsive to any stimuli after a certain time. Several sugges-
be used as a soothing scent, especially in patients with high tension. tions for the duration of oil applications have been made [37]. The
It is known that odours have different effects and can change moods anticipated effects in the present study might have been obtained by the
[17]. They can also alter heart rate [23,29,30]. In a double-blind, reduction of the adaptation mechanism in the brain with the preferred
randomized controlled study, it was observed that the sedative effect of protocol (3 min of application).
imipramine was increased when used with lavender in the treatment of Beside the positive effects, some adverse reactions such as induced
depression [31]. Lin concluded that lavender oil could be preferred over estrogenic activity have been reported, especially following repeated
medications in vulnerable patients for the alleviation of anxiety levels topical applications of some essential oils. A case report showed the
[32]. The use of lavender oil on animals revealed the sedative effects of correlation of estrogenic and anti-androgenic activities with the topical
lavender oil inhalation, yielding a similar impact on behaviours as use of lavender and tea tree oil, which is thought to be the cause of
benzodiazepines [16]. These drugs act as GABA receptor agonists; gynecomastia in pre-pubertal boys. However, gynecomastia was re-
however, they have adverse effects such as fatigue, ataxia, and pro- solved when the use of the preparations was discontinued [29]. Po-
longed sedation [18]. Considering the positive psychiatric effects tential allergic skin reactions with the application of lavender oil on
without adverse reactions, the application of lavender oil preparations wounds have been reported. With this concern, lavender oil was tested
was investigated in animal studies. As a result, the injection of lavender and found to be cytotoxic on human skin cells in an in-vitro study. In
oil created diazepam-like dose-dependent sedative effects [15]. Dose- addition, linalyl acetate, one of the major components of this oil,
dependent positive sedative effects of lavender oil similar to anxiolytic showed maximum cytotoxic damage [40]. Conversely, some re-
agents have been shown and anxiolytic effects have even been attained searchers observed beneficial effects of lavender oil application on soft
with intermediate doses [16,33]. Lavender supplements (oral, olfac- tissue lesions and chronic wounds. Woollard et al. [41] Vakilian et al.
tory, topical) are also used for the treatment of agitated behaviour in [42] and Marzouk et al. [43] proved that, a sitz bath with lavender oil
severe dementia and anxiety disorders [34,35]. Silexan, which is had a positive effect on episiotomy wounds and provided better healing

4
N.B. Karan Physiology & Behavior 211 (2019) 112676

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