Trial Outcomes & Findings for Effects of Aromatherapy on Nausea Levels (NCT NCT04882501)
NCT ID: NCT04882501
Last Updated: 2024-11-29
Results Overview
Measured participants self reported nausea level pre ( Baseline) and post intervention VAS 0 - no nausea VAS 1- Mild Nausea VAS 2- Moderate Nausea VAS 3 - Severe nausea
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
Up to 24 hours post operatively
Results posted on
2024-11-29
Participant Flow
Inova Fair Oaks Hospital Started April 19, 2021 Ended August 24, 2022
Participant milestones
| Measure |
Actual Aromatherapy Product
QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization
QUEASEEase aromatherapy quick tab: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
|
Placebo Product
Placebo product (normal saline) 50% chance of participant receiving based on randomization
Placebo product: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
58
|
|
Overall Study
COMPLETED
|
55
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There were male, female and another category
Baseline characteristics by cohort
| Measure |
Actual Aromatherapy Product
n=55 Participants
QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization
QUEASEEase aromatherapy quick tab: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
|
Placebo Product
n=58 Participants
Placebo product (normal saline) 50% chance of participant receiving based on randomization
Placebo product: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
|
Total
n=113 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
|
55 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38 years
n=5 Participants
|
41 years
n=7 Participants
|
39.3 years
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
2 Participants
n=5 Participants • There were male, female and another category
|
4 Participants
n=7 Participants • There were male, female and another category
|
6 Participants
n=5 Participants • There were male, female and another category
|
|
Sex/Gender, Customized
Female
|
52 Participants
n=5 Participants • There were male, female and another category
|
54 Participants
n=7 Participants • There were male, female and another category
|
106 Participants
n=5 Participants • There were male, female and another category
|
|
Sex/Gender, Customized
Decline to answer
|
1 Participants
n=5 Participants • There were male, female and another category
|
0 Participants
n=7 Participants • There were male, female and another category
|
1 Participants
n=5 Participants • There were male, female and another category
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
58 participants
n=7 Participants
|
113 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours post operativelyMeasured participants self reported nausea level pre ( Baseline) and post intervention VAS 0 - no nausea VAS 1- Mild Nausea VAS 2- Moderate Nausea VAS 3 - Severe nausea
Outcome measures
| Measure |
Actual Aromatherapy Product
n=55 Participants
QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization
QUEASEEase aromatherapy quick tab: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
|
Placebo Product
n=58 Participants
Placebo product (normal saline) 50% chance of participant receiving based on randomization
Placebo product: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
|
|---|---|---|
|
Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3
Post- intervention · VAS 1
|
20 Participants
|
17 Participants
|
|
Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3
Post- intervention · VAS 2
|
14 Participants
|
17 Participants
|
|
Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3
Post- intervention · VAS 3
|
5 Participants
|
12 Participants
|
|
Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3
Baseline · VAS O
|
0 Participants
|
0 Participants
|
|
Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3
Baseline · VAS 1
|
13 Participants
|
13 Participants
|
|
Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3
Baseline · VAS 2
|
27 Participants
|
25 Participants
|
|
Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3
Baseline · VAS 3
|
15 Participants
|
20 Participants
|
|
Patient Reported Nausea as Measured Visual Analog Scale (VAS) From 0-3
Post- intervention · VAS O
|
16 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to 24 hours post operatively.This the number of patients who received an anti- emetic for nausea after receiving post study intervention.
Outcome measures
| Measure |
Actual Aromatherapy Product
n=55 Participants
QUEASEEase quick tab Aromatherapy product 50 % chance of participant receiving based on randomization
QUEASEEase aromatherapy quick tab: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
|
Placebo Product
n=58 Participants
Placebo product (normal saline) 50% chance of participant receiving based on randomization
Placebo product: Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
|
|---|---|---|
|
Total Number of Participants Who Received an Anti-emetic Post Study Intervention.
|
48 Participants
|
50 Participants
|
Adverse Events
Actual Aromatherapy Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Product
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
Principal Investigator Inova Fair Oaks Hospital
InovaHCS
Phone: 703 391-4892
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place