Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood
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|ClinicalTrials.gov Identifier: NCT03093454|
Recruitment Status : Completed
First Posted : March 28, 2017
Results First Posted : April 1, 2021
Last Update Posted : April 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Lavender Essential Oil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|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|
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
- Effects of Lavender Oil on Postoperative Pain Through Pain Scores [ Time Frame: Pre-operatively, Post-op Day 1 (POD1), and final post-op day (final POD) ]
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.
- Effects of Lavender Oil on Sleep [ Time Frame: Pre-operatively, Post-op Day 1(POD1), and final Post-op Day (final POD) ]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.
- Effects of Lavender Oil on Mood [ Time Frame: Pre-operatively, Post-op Day 1 (POD1), Final Post-op Day (Final POD) ]
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).
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
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Scott Hollenbeck, MD||Duke|