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Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03093454
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
dōTERRA International
Information provided by (Responsible Party):
Scott Hollenbeck, MD, Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Lavender Essential Oil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
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
Official Title: Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood
Actual Study Start Date : October 27, 2017
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
No intervention patient will receive current standard of care treatment and will answer surveys to collect data.
Experimental: Lavender Group
Patient will receive lavender essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Drug: Lavender Essential Oil
Lavender essential oil will be applied topically and by inhalation to the lavender group.
Other Name: Lavandula angustifolia




Primary Outcome Measures :
  1. Effects of Lavender Oil on Postoperative Pain through pain scores [ Time Frame: hospital stay of 1-4 days ]
    assess pain through pain scores documented in medical record compared to control group

  2. Effects of Lavender Oil on Postoperative Pain through narcotic use [ Time Frame: hospital stay of 1-4 days ]
    assess pain through documentation of total narcotic use compared to the control group

  3. Effects of Lavender Oil on Postoperative Pain through pain satisfaction survey [ Time Frame: hospital stay of 1-4 days ]
    assess pain through daily pain satisfaction survey score compared to control group


Secondary Outcome Measures :
  1. Effects of Lavender Oil on Sleep [ Time Frame: hospital stay of 1-4 days ]
    assess sleep quality by Richards Campbell sleep questionnaire survey

  2. Effects of Lavender Oil on Mood [ Time Frame: hospital stay of 1-4 days ]
    assess anxiety by hospital anxiety depression scale survey



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093454


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Scott Hollenbeck, MD
dōTERRA International
Investigators
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Principal Investigator: Scott Hollenbeck, MD Duke
Publications:

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Responsible Party: Scott Hollenbeck, MD, Surgeon, Duke University
ClinicalTrials.gov Identifier: NCT03093454    
Other Study ID Numbers: Pro00071214
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations