Trial Outcomes & Findings for Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood (NCT NCT03093454)
NCT ID: NCT03093454
Last Updated: 2021-04-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
58 participants
Primary outcome timeframe
Pre-operatively, Post-op Day 1 (POD1), and final post-op day (final POD)
Results posted on
2021-04-01
Participant Flow
Participant milestones
| Measure |
Control Group
Patient received coconut essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Coconut Essential Oil: will be applied topically and by inhalation to the control group.
Completed daily surveys during inpatient stay in the hospital.
|
Lavender Group
Patient received lavender essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Lavender Essential Oil: Lavender essential oil was applied topically and by inhalation to the lavender group.
Completed daily surveys during inpatient stay in the hospital.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
COMPLETED
|
22
|
27
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Control Group
Patient received coconut essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Coconut Essential Oil: will be applied topically and by inhalation to the control group.
Completed daily surveys during inpatient stay in the hospital.
|
Lavender Group
Patient received lavender essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Lavender Essential Oil: Lavender essential oil was applied topically and by inhalation to the lavender group.
Completed daily surveys during inpatient stay in the hospital.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Scheduling conflict
|
3
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
Baseline Characteristics
Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood
Baseline characteristics by cohort
| Measure |
Placebo/Control
n=22 Participants
Patient will receive coconut essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Coconut Essential Oil: Coconut essential oil will be applied topically and by inhalation to the control group.
|
Lavender Group
n=27 Participants
Patient will receive lavender essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Lavender Essential Oil: Lavender essential oil will be applied topically and by inhalation to the lavender group.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-operatively, Post-op Day 1 (POD1), and final post-op day (final POD)Population: A total of 9 subjects were with drawn from the analysis as described in participant flow section. 58 subjects originally signed consent and 49 completed the study and used for analysis.
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.
Outcome measures
| Measure |
Control Group
n=22 Participants
Patient received coconut essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Coconut Essential Oil: will be applied topically and by inhalation to the control group.
Completed daily surveys during inpatient stay in the hospital.
|
Lavender Group
n=27 Participants
Patient received lavender essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Lavender Essential Oil: Lavender essential oil was applied topically and by inhalation to the lavender group.
Completed daily surveys during inpatient stay in the hospital.
|
|---|---|---|
|
Effects of Lavender Oil on Postoperative Pain Through Pain Scores
Preoperative
|
0.5 score on a scale
Standard Deviation 1.36
|
0.9 score on a scale
Standard Deviation 1.80
|
|
Effects of Lavender Oil on Postoperative Pain Through Pain Scores
Post-op Day 1 (POD1)
|
3.5 score on a scale
Standard Deviation 1.91
|
3.1 score on a scale
Standard Deviation 2.74
|
|
Effects of Lavender Oil on Postoperative Pain Through Pain Scores
Final Post-op Day (final POD)
|
2.5 score on a scale
Standard Deviation 1.92
|
2.9 score on a scale
Standard Deviation 2.81
|
PRIMARY outcome
Timeframe: Pre-operatively, Post-op Day 1(POD1), and final Post-op Day (final POD)Population: A total of 9 subjects were with drawn from the analysis as described in participant flow section. 58 subjects originally signed consent and 49 completed the study and used for analysis.
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.
Outcome measures
| Measure |
Control Group
n=22 Participants
Patient received coconut essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Coconut Essential Oil: will be applied topically and by inhalation to the control group.
Completed daily surveys during inpatient stay in the hospital.
|
Lavender Group
n=27 Participants
Patient received lavender essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Lavender Essential Oil: Lavender essential oil was applied topically and by inhalation to the lavender group.
Completed daily surveys during inpatient stay in the hospital.
|
|---|---|---|
|
Effects of Lavender Oil on Sleep
Pre-operative
|
6.5 score on a scale
Standard Deviation 2.61
|
5.6 score on a scale
Standard Deviation 2.39
|
|
Effects of Lavender Oil on Sleep
Post-op Day 1 (POD1)
|
5.5 score on a scale
Standard Deviation 1.97
|
5.1 score on a scale
Standard Deviation 2.08
|
|
Effects of Lavender Oil on Sleep
Final Post-op Day (Final POD)
|
6.6 score on a scale
Standard Deviation 2.43
|
7.4 score on a scale
Standard Deviation 1.71
|
PRIMARY outcome
Timeframe: Pre-operatively, Post-op Day 1 (POD1), Final Post-op Day (Final POD)Population: A total of 9 subjects were with drawn from the analysis as described in participant flow section. 58 subjects originally signed consent and 49 completed the study and used for analysis.
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).
Outcome measures
| Measure |
Control Group
n=22 Participants
Patient received coconut essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Coconut Essential Oil: will be applied topically and by inhalation to the control group.
Completed daily surveys during inpatient stay in the hospital.
|
Lavender Group
n=27 Participants
Patient received lavender essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.
Lavender Essential Oil: Lavender essential oil was applied topically and by inhalation to the lavender group.
Completed daily surveys during inpatient stay in the hospital.
|
|---|---|---|
|
Effects of Lavender Oil on Mood
Pre-operative
|
14.9 units on a scale
Standard Deviation 1.68
|
14.4 units on a scale
Standard Deviation 1.77
|
|
Effects of Lavender Oil on Mood
Post-op Day 1 (POD1)
|
14.8 units on a scale
Standard Deviation 2.14
|
15.0 units on a scale
Standard Deviation 2.84
|
|
Effects of Lavender Oil on Mood
Final Post-op Day (Final POD)
|
15.8 units on a scale
Standard Deviation 2.77
|
15.7 units on a scale
Standard Deviation 1.11
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lavender Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60