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

NCT03093454 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: Pro00071214
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (3)

• Effects of Lavender Oil on Postoperative Pain Through Pain Scores

  Assess pain through pain scores documented in medical record compared to control group. Pain score of 0 is no pain versus pain score of 10 is highest pain possible.

  Pre-operatively, Post-op Day 1 (POD1), and final post-op day (final POD)

• Effects of Lavender Oil on Sleep

  Assess sleep quality by Richards Campbell sleep questionnaire survey A score of zero (0) minimal if any sleep at all versus 10 deep and sound sleeping during hospital stay.

  Pre-operatively, Post-op Day 1(POD1), and final Post-op Day (final POD)

• Effects of Lavender Oil on Mood

  Assess anxiety by hospital anxiety depression scale survey This 14-component scoring system is used to tabulate a total sum score (0-42) or separate anxiety and depression scores (0-21). A higher score represents a more severe degree of anxiety and/or depression. The severity of a patient's anxiety or depression may then be grouped into three categories based on the score (Normal, 0-7; Borderline abnormal, 8-10; Abnormal 11-21).

  Pre-operatively, Post-op Day 1 (POD1), Final Post-op Day (Final POD)

Study Arms (2)

Control

NO INTERVENTION

No intervention patient will receive current standard of care treatment and will answer surveys to collect data.

Lavender Group

EXPERIMENTAL

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

Interventions

Lavender Essential Oil DRUG

Lavender essential oil will be applied topically and by inhalation to the lavender group.

Also known as: Lavandula angustifolia

Lavender Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing any form of breast reconstruction therapy
• Ages 18-85
• At least a one night stay in hospital after surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scott Hollenbeck, MD: lead
• dōTERRA International: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (9)

• Vakili N, Gorji A. Psychiatry and psychology in medieval Persia. J Clin Psychiatry. 2006 Dec;67(12):1862-9. doi: 10.4088/jcp.v67n1205.

  PMID: 17194263 BACKGROUND

• Gorji A, Khaleghi Ghadiri M. History of headache in medieval Persian medicine. Lancet Neurol. 2002 Dec;1(8):510-5. doi: 10.1016/s1474-4422(02)00226-0.

  PMID: 12849336 BACKGROUND

• Woelk H, Schlafke S. A multi-center, double-blind, randomised study of the Lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder. Phytomedicine. 2010 Feb;17(2):94-9. doi: 10.1016/j.phymed.2009.10.006. Epub 2009 Dec 3.

  PMID: 19962288 BACKGROUND

• Moeini M, Khadibi M, Bekhradi R, Mahmoudian SA, Nazari F. Effect of aromatherapy on the quality of sleep in ischemic heart disease patients hospitalized in intensive care units of heart hospitals of the Isfahan University of Medical Sciences. Iran J Nurs Midwifery Res. 2010 Fall;15(4):234-9.

  PMID: 22049287 BACKGROUND

• Kim JT, Wajda M, Cuff G, Serota D, Schlame M, Axelrod DM, Guth AA, Bekker AY. Evaluation of aromatherapy in treating postoperative pain: pilot study. Pain Pract. 2006 Dec;6(4):273-7. doi: 10.1111/j.1533-2500.2006.00095.x.

  PMID: 17129308 BACKGROUND

• Kim JT, Ren CJ, Fielding GA, Pitti A, Kasumi T, Wajda M, Lebovits A, Bekker A. Treatment with lavender aromatherapy in the post-anesthesia care unit reduces opioid requirements of morbidly obese patients undergoing laparoscopic adjustable gastric banding. Obes Surg. 2007 Jul;17(7):920-5. doi: 10.1007/s11695-007-9170-7.

  PMID: 17894152 BACKGROUND

• Soltani R, Soheilipour S, Hajhashemi V, Asghari G, Bagheri M, Molavi M. Evaluation 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 Sep;77(9):1579-81. doi: 10.1016/j.ijporl.2013.07.014. Epub 2013 Aug 8.

  PMID: 23932834 BACKGROUND

• Koulivand PH, Khaleghi Ghadiri M, Gorji A. Lavender and the nervous system. Evid Based Complement Alternat Med. 2013;2013:681304. doi: 10.1155/2013/681304. Epub 2013 Mar 14.

  PMID: 23573142 BACKGROUND

• Heidari Gorji MA, Ashrastaghi OG, Habibi V, Charati JY, Ebrahimzadeh MA, Ayasi M. The effectiveness of lavender essence on strernotomy related pain intensity after coronary artery bypass grafting. Adv Biomed Res. 2015 Jun 4;4:127. doi: 10.4103/2277-9175.158050. eCollection 2015.

  PMID: 26261829 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Scott Hollenbeck, MD
• Organization: Duke Health

scott.hollenbeck@duke.edu

919-681-5079

Study Officials

• Scott Hollenbeck, MD

  Duke

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Surgeon

Model Details: 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 Record Dates

• First Submitted: March 10, 2017
• First Posted: March 28, 2017
• Study Start: October 27, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: April 1, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)