Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood
Phase: PHASE3
Conditions: Pain, Postoperative
Sponsor: Scott Hollenbeck, MD

NCT03093454 
Date 24 October 2017  
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Research Summary 
 
1.  Protocol Title:  
Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood. 
 
2.  Purpose of the Study:  
The purpose of this study is to evaluate the integration of lavender essential oil in surgical 
patients during the perioperative and postoperative phase of care. The study will assess 
patients’ pain, sleep quality, and mood. The goal is to support that lavender oil will 
decrease pain scores and narcotic use, increase sleep quality, and decrease anxiety by 
improving overall patient satisfaction and supporting their natural sense of well-being. This 
research project will help support the use of complementary medicine in a hospital setting. 
The increased awareness and use of complementary medicine in a hospital setting will 
strengthen the patient centered care model that all hospitals strive to achieve. 
 
3.  Background & Significance:  
Essential oils have been formally documented in use since the time of the Egyptians. The 
Ebers Papyrus document notes Egyptians using frankincense for different physical ailments 
[1]. In Greece Hippocrates used essential oils to fumigate the city of Athens to fight off the 
plague [1]. In medieval periods lavender essential oil was used for its antidepressive, 
anxiolytic, sedative, and analgesic properties. Medieval Persian physicians made records 
of their treatment plans which included lavender for depression and pain for headaches 
[2,3]. With the invention of steam distillation to separate the essential oil from the plant  
Europe began to use oils in perfumes and for medicinal benefits in the 1500’s. Two 
physicians named Hieronymus and Brunschwig wrote one of the earliest printed books on 
the distillation and use of essential oils for medical benefits [4]. By the 19th century a French 
chemist Rene- Maurice Gattefosse was known for studying essential oils and their 
therapeutic benefits. His work and documentation led the way for the support of essential 
oil in medical ailments. Robert Tisserand in the early 1990s reviewed the French chemists 
work and added to his research to help make essential oils more known to the public in 
present day [1].   
 
In recent years lavender has been studied on human subjects to tests its known reputation 
for sedative, anxiolytic, and analgesic properties. In one clinical trial oral administration of 
lavender was compared to Ativan 0.5mg for generalized anxiety disorder. The study 
supported that the oral lavender oil called Silexan was as effective as 0.5mg of Ativan in 
adults with generalized anxiety disorder [5]. A second clinical trial analyzing sleep quality 
found that ischemic heart patients in the intensive care unit received better sleep with 100% 
lavender oil undiluted placed on a cotton ball within 20cm from the patient from the hours of 
9pm-6am [6]. Two studies have used lavender oil through inhalation in the recovery room 
with an oxygen mask after surgery for pain control. The first study was patients after breast 
biopsy, the second was patients who just had laparoscopic adjustable gastric banding [7,8]. 
The study with the breast biopsy patients showed a higher satisfaction rate with pain. The 
patients undergoing laparoscopic banding also showed a higher rate of satisfaction with 
pain as well as decreased opioid use in the recovery room. Furthermore one study used 
100% lavender oil undiluted on the skin of pediatric patients undergoing tonsillectomy as a 
topical application and asked the patients to inhale. The study showed a decrease use in 
Tylenol usage postoperatively [9]. 
 

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4.  Design & Procedures:  
Design 
Randomized study with control group and test group. Using a 1:1 treatment allocation ratio, 
the total of 60 patients (30 per arm) will be randomly assigned to control or treatment arm. 
The Statistical Investigator will generate the randomization scheme and monitor the 
randomization process over the course of the trial. The study will use randomization with 
random permuted blocks. The test group will receive 50% lavender oil diluted in fractionated 
coconut oil and the control group will have the current standard of care with no essential oil 
intervention (coconut oil only) will be applied. Fractionated coconut oil is being used because 
it is colorless, odorless, does not stain clothing, and has a long shelf life. It also serves as a 
carrier oil for the essential oil to absorb into the skin instead of evaporating off the skin due 
to essential oils volatile nature. 
 
Study Procedure 
The lavender essential oil used will be from the company doTERRA. This essential oil 
company was chosen because this company has a medical and science governing board 
made up of physicians, surgeons, chemists and pharmacists.  The oil is also third party tested 
by Dr. Robert Pappas a trusted chemist in the essential oil community for purity and quality. 
Gas chromatography and mass spectrometry are used to ensure purity and no unwanted 
substances are in the essential oil. doTERRA’s essential oils have also already been used 
in a hospital setting at Vanderbilt University hospital in Tennessee. doTERRA’s essential oils 
were diffused in the Vanderbilt ER at the nursing stations. After 3 months of diffusing staff 
felt less work related stress, less time feeling overwhelmed, and had more energy at work 
[13]. 
 
5.  Selection of Subjects: 
Potential subjects will be selected from the clinic of Dr. Scott Hollenbeck. Subjects will be 
consented by investigators or study key personnel. 
 
Inclusion Criteria: 
Women undergoing any form of breast reconstruction therapy 
Ages 18-85 
At least a one night stay in hospital after surgery 
 
Exclusion Criteria: 
Sensitivity or allergy to coconut 
Use of sleeping aide drugs 
Use of benzodiazepines 
History of any of the following:  asthma, eczema, allergy to flowers, smell disorders 
      Sensitivity to lavender oil or any of its ingredients 
      Pregnant women will be excluded from the study. During routine preoperative testing the          
      patient’s menstrual history or urine pregnancy test will be performed to identify any patient                  
      who is pregnant.      
 
6.  Subject Recruitment & Compensation: 
Enrollment goal will be 60 subjects.  We anticipate enrolling 60 subjects over 6 months and 
anticipate the trial to be complete within 1 year. The subjects will not be compensated for the 
study. 
 

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Date 24 October 2017  
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7.  Consent Process – see Section 14 of the e-IRB submission form and complete the questions 
in that section.   
 
8.  Subject’s Capacity to Give Legally Effective Consent: 
 
9.  Study Interventions: 
After informed consent is obtained, exactly 4 drops of 50% lavender solution will be placed 
on the wrist over the radial artery. The patient will rub her wrists and hands together and then 
inhale and exhale slowly for one minute. This will occur thirty minutes before being taken to 
the operating room. The dilution of 50% was chosen after reviewing Robert Tisserand’s book 
on essential oil safety, consulting a local certified aromatherapist, Cynthia Loving, and 
consulting Dr. David Hill, executive vice president and chief medical officer of doTERRA 
essential oils [10]. This percent dilution is recommended on skin and is not likely to cause 
irritation to the skin. Repeated insult patch skin testing from doTERRA has supported this 
dilution rate to be safe to the skin. Furthermore a previous study used 100 % lavender oil on 
children age 5-12 undergoing tonsillectomy with no adverse reactions [9]. The first dose will 
be given thirty minutes prior to the operating room because it takes 20 minutes for lavender 
to be absorbed thought the skin and reach peak plasma levels [11,12].  
 
During surgery the patient will receive 4 drops of 50% solution lavender oil on the temple 
region over the temporal artery every 2 hours until completion of surgery. This will be applied 
by the anesthesia team. If the temporal region is not accessible the shoulders or feet will be 
alternate locations of application. When the patient arrives to the recovery room she will 
receive lavender oil through an oxygen mask. A 50 % solution will be used by placing 4 drops 
of the lavender solution on the mask and wiping it around the mask with a cotton ball. This 
delivery method will be used because this was used in a study from New York University 
Medical Center studying postoperative pain and no adverse events occurred [7]. When the 
patient is on the post-operative floor she will receive 50 % lavender oil on the wrist every 4 
hours in the same manner as preoperatively from the hours of 6am to 9pm. Nightly (9pm-
6am), 8 drops of 50% lavender oil will be placed on the cotton ball situated within 20cm of 
the patient. This method and concentration was chosen after reviewing a study in ischemic 
heart patients in the intensive care unit. The patients received lavender at bedside on a cotton 
ball and had statistically significant better sleep quality [6].   The control group will have 
coconut oil applied without any lavender oil applied in the same sequence as listed above.  
This will ensure the same procedures are carried out under both arms.   
 
Blood pressure, pulse, respiratory rate, and oxygen saturation will be monitored in the 
preoperative area before lavender is given and 30 minutes after it is given. The level of pain 
will also be asked prior to application and at the second set of vitals. The control group will 
get two sets of vital measurements and pain scale measurements without any intervention.  
The same vitals will be recorded while the patient is under anesthesia every 30 minutes. 
There will be a notation in the chart when lavender is given to correlate time from application 
to time of vitals recorded. A review of the electronic medical record will be done to record 
amount of narcotic needed interop in both groups.   
 
In the recovery room after the patient is given lavender through the oxygen mask the same 
vital signs and pain score measurement will be taken 15, 30, and 60 minutes from lavender 
application. In the control group on arrival to the recovery room the same data points will be 

NCT03093454 
Date 24 October 2017  
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measured with the same time intervals with coconut oil only. The amount of narcotic needed 
in the recovery room will be taken from the electronic medical record for each group.  
Postoperatively on the floor vital signs as noted above will be recorded every 4 hours. At 
each 4 hour interval after the vital signs are taken lavender will be applied to the experimental 
group and no intervention in the control group. One more set of vitals signs will be recorded 
45min after application of lavender each time lavender is applied. There will be a review of 
narcotic use from the electronic medical record from both groups. There will be a notation 
when lavender was given to correlate lavender application and narcotic use. 
The anxiety questionnaire will be given preop before the application of lavender and then 
daily for every post-op day they stay. The questionnaire is called the hospital anxiety and 
depression scale. 
 
The sleep questionnaire will be given in preop before application of lavender and then daily 
for every post-op day they stay. The sleep questionnaire is called the Richard Campbell 
Sleep Questionnaire. 
 
Daily starting on postop day 1 the patient will also record their level of satisfaction of pain 
control from a scale of 1-10 with 1 being not satisfied and 10 being satisfied.  Patients typically 
stay in hospital 1-3 days post-op.  A survey will be filled out daily. 
 
10. Risk/Benefit Assessment: 
The use of lavender essential oil could have potential benefits to the patient: 
o Main benefits include decreased pain, better sleep, and better mood.  
o Other benefits include relaxation, calming environment, pleasing aroma. 
 
Risks are minimal, but there is potential for some adverse events:  
o Possible side effects include skin irritation or coughing. 
 If skin irritation occurs, plain fractionated coconut oil will be applied to dilute the 
essential oil. Then a 4x4 cotton gauze will be used to wipe off the essential oil. The 
coconut oil will be applied a second time and then removed by a 4x4. Washing is not 
a recommend step because water will drive the essential oil into the skin further.  If 
there is still a reaction and the patient is uncomfortable oral Benadryl will be given, 
25mg PO Q6hrs prn itching or skin irritation.  In the control arm, should the coconut 
oil irritate the skin it will be removed using a 4 x 4 cotton swab.   
 For coughing or any feeling of shortness of breath or chest discomfort, lavender oil 
therapy will be stopped. Any lavender applied to the skin will be diluted with 
fractionated coconut oil as mentioned above. 
 For any serious, unexpected event, which occurs to any subject during this study the 
appropriate DUHS IRB Adverse Event notification will be completed, e-signed by the 
PI and submitted to the DUHS IRB within 5 days of notification of the reported event. 
 Any patient who does not want to participate in the study can decline at any time. 
 The patient’s demographics including name will remain confidential. 
 
 
11. Costs to the Subject: 
Study intervention and Lavender Oil will be provided to subjects at no additional cost.  
Subjects and/or their regular insurance provider will be responsible for all procedures and 
tests considered standard of care for their condition. 
 

NCT03093454 
Date 24 October 2017  
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12. Data Analysis & Statistical Considerations: 
Study Design/Endpoints:  The primary outcome will be a difference in pain scores between 
the 2 groups and/or decrease in narcotic use and/or increased patient satisfaction of pain 
control. Secondary outcomes are better sleep and decreased anxiety. 
 
Analytic Plan and Method: Differences in the change scores of pain in the two groups as well 
any other demographic and clinical continuous variables will be examined using t-test or 
Wilcoxon test, depending on whether the variables are normally or non-normally distributed 
respectively. The differences between the categorical variables will be examined using chi-
squared or Fisher’s exact test.  Analysis will be conducted under the intention to treat (ITT). 
Missing data will be imputed under multiple imputation methods. Differences in the outcomes 
while controlling for potential covariates (age, etc) will be examined using linear regression. 
Significance of the tests will be assessed at alpha = 0.05. Analysis will be conducted using 
SAS 9.4 (SAS Institute, Inc., Cary, NC.). 
 
Power and Sample Size Calculations: A study called the effectiveness of lavender 
essence on sternotomy related pain intensity after coronary artery bypass grafting 
evaluated the effectiveness of lavender. The study observed pain scores of 6.45 (SD: 2.23) 
and 4.11 (2.13) in the control and treatment groups respectively [14]. For 80% power at 
alpha = 0.05, with the above observed means and standard deviations in the control and 
treatment groups, 15 subjects per group will be needed. Assuming about a 20% drop-out 
rate, the study would need 17 subjects per group. 
 
13. Data & Safety Monitoring:  
Data and safety monitoring will be reviewed by a team of experts (a least 2 physicians will 
be identified by the PI in this area of research and who are not associated with this study). 
Adverse events (AE) and serious adverse events (SAE) will be examined by the committee. 
We plan to have a review of the safety data in a meeting when half the study subjects are 
recruited into the study. The committee will decide on the continuity of the trial after reviewing 
the SAEs while ensuring the safety of the patients. 
 
14. Privacy, Data Storage & Confidentiality – see Section 12 of the e-IRB submission form 
and complete the questions in that section.   
 
References.  
1. Jane Buckle. Clinical Aromatherapy Essential Oils in Healthcare. Churchill Livingstone 
Elsevier;2015.2-13. 
2. N. Vakili and A. Gorji. Psychiatry and psychology in medieval Persia. Journal of Clinical 
Psychiatry. 2006;67:1862-1869. 
3. A. Gorji and M.K.Ghadiri. History of headache in medieval Persian medicine. Lancet 
Neurology. 2002;1:510-515. 
4. Aroma Tools. Modern essentials: a contemporary guide to the therapeutic use of 
essential oils. Utah: Aroma Tools; 2014. 11 p. 
5. H. Woelk and S, Schlafke. A multi-center, double-blind, randomized study of the lavender 
oil preparation silexan in comparison to lorazepam for generalized anxiety disorder. 
Phytomedicine. 2010;17: 94-99. 
6. Moeini M, Khadibi M, Bekharadi R, et al. Effects of aromatherapy on the quality of sleep 
in ischemic heart disease patients hospitalized in intensive care units of heart hospitals 

NCT03093454 
Date 24 October 2017  
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of the Isfahan university of medical sciences. Iranian Journal of Nursing and Midwifery 
Research. 2010;15:234-239 
7. Kim J, Wajda M, Cuff G, et al. Evaluation of aromatherapy in treating postoperative 
pain:pilot study. Pain Practice.2006;6:273-277. 
8. Kim J, Ren C, Fielding G, et al.Treatment with lavender aromatherapy in the post-
anesthesia care unit reduces opioid requirements of morbidly obese patients undergoing 
laparoscopic adjustable gastric banding. Obes Surgery.2007;7:920-925. 
9. Soltani R, Soheilipour S, Hajhashemi V, et al. Evalutaion of the effect of aromatherapy 
with lavender essential oil on post-tonsillectomy pain in pediatric patients: a randomized 
controlled trial. Int J Pediatr Otorhinolaryngol. 2013;9:1579-1581. 
10. Robert Tisserand and Rodney Young. Essential oil safety. China: Churchill Livingstone 
Elsevier;2014. 47. 
11. Jager W, Buchbauer G, Jirotvetz L, et al. Percutaneous absorption of lavender oil from 
a massage oil. Journal of the society of cosmetic chemists.1992;43:49-54. 
12. Koulivand P, Ghadiri M, Gorji A. Lavender and the Nervous system. Evidence-based 
complementary and alternative medicine.2013 
13. Mcbirde T, and Sturges T. Opening minds closed to the possibilities of using essential 
oils. doTERRA Living Magazine  Fall 2012 p 26-27. 
14. Heidari G, Ashrastaghi H. et al. The effectiveness of lavender essence on sternotomy 
related pain intensity after coronary artery bypass grafting. Adv Biomed Res. 2015;4:127.