Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      This project will 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.
    

Detailed description: 
      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. In
      Greece Hippocrates used essential oils to fumigate the city of Athens to fight off the
      plague. 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. 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. 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.

      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. 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.
      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. 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.

      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. 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.

      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. 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. 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.

      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. 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. The control group will
      have the current standard of care with no lavender intervention.

      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 measured with the same time intervals with no intervention. 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.

      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. The secondary outcome will be a
      difference in scores from the two surveys, the Richards Campbell sleep questionnaire and the
      Hospital Anxiety Depression Scale.

      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.).
    

Intervention name(s): Lavender Essential Oil
Intervention type(s): Drug
Intervention description(s): Lavender essential oil will be applied topically and by inhalation to the lavender group.
Other intervention name(s): Lavandula angustifolia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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. 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.
Masking: None (Open Label)
Primary purpose: Supportive Care