Trial Outcomes & Findings for Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder (NCT NCT06319898)
NCT ID: NCT06319898
Last Updated: 2025-04-22
Results Overview
The VAS for anxiety is a validated scale that ranges from 0-100mm. 0mm is equivalent to "no anxiety" and is located on the left. 100mm is equivalent to "extremely anxious" and is located on the right. The minimum clinically important difference for VAS anxiety is a change of 12mm on a 100mm scale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
Baseline to Minute 30
Results posted on
2025-04-22
Participant Flow
Participant milestones
| Measure |
Lavender Aromatherapy Sticker
Lavender aromatherapy sticker on patient Calming music from Sirius station 68 (Spa) playing via overhead speakers Overhead lights off, two lanterns lit to provide dim lighting Avoid stirrup use
|
Control - no Intervention
Non-aromatic (placebo) sticker on patient No music playing Overhead lights on Stirrups used
|
Procedure Team Intervention - Relaxing Environment
Lavender aromatherapy, calming music and dim lighting
|
Procedure Team - no Intervention
No intervention in Procedure Room
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
47
|
10
|
11
|
|
Overall Study
COMPLETED
|
40
|
40
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
Baseline characteristics by cohort
| Measure |
Lavender Aromatherapy Sticker
n=40 Participants
Lavender aromatherapy sticker on patient Calming music from Sirius station 68 (Spa) playing via overhead speakers Overhead lights off, two lanterns lit to provide dim lighting Avoid stirrup use
|
Control - no Intervention
n=40 Participants
Non-aromatic (placebo) sticker on patient No music playing Overhead lights on Stirrups used
|
Procedure Team Intervention - Relaxing Environment
n=10 Participants
Lavender aromatherapy Calming music Overhead lights off
|
Procedure Team - no Intervention
n=11 Participants
Non-aromatic No music playing Overhead lights on
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 11.6 • n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
69.1 years
STANDARD_DEVIATION 13.1 • n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
—
|
—
|
70.7 years
STANDARD_DEVIATION 12.4 • n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Sex: Female, Male
Female
|
40 Participants
n=40 Participants
|
40 Participants
n=40 Participants
|
9 Participants
n=10 Participants
|
10 Participants
n=11 Participants
|
99 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
—
|
—
|
1 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
40 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
—
|
—
|
78 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
—
|
—
|
1 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
—
|
—
|
0 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
—
|
—
|
0 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
—
|
—
|
0 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
7 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
—
|
—
|
11 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Race (NIH/OMB)
White
|
35 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
33 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
—
|
—
|
68 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
—
|
—
|
1 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
—
|
—
|
0 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Tobacco use
Never smoker
|
28 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
23 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
51 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Tobacco use
Former smoker
|
12 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
16 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
28 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Tobacco use
Current smoker
|
0 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
1 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
1 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Body mass index
|
29.6 kg/m^2
STANDARD_DEVIATION 6.7 • n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
30.9 kg/m^2
STANDARD_DEVIATION 7.6 • n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
—
|
—
|
30.2 kg/m^2
STANDARD_DEVIATION 7.1 • n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
First-time bladder chemodenervation experience
yes
|
9 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
8 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
0 Participants
This measurement was not collected on Procedure Team Members
|
0 Participants
This measurement was not collected on Procedure Team Members
|
17 Participants
n=80 Participants • This measurement was not collected on Procedure Team Members
|
|
First-time bladder chemodenervation experience
no
|
31 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
32 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
0 Participants
This measurement was not collected on Procedure Team Members
|
0 Participants
This measurement was not collected on Procedure Team Members
|
63 Participants
n=80 Participants • This measurement was not collected on Procedure Team Members
|
|
Anxiety diagnosis
yes
|
7 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
10 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
17 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Anxiety diagnosis
no
|
33 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
30 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
63 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Pain medication use
yes
|
10 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
13 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
23 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Pain medication use
no
|
30 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
27 Participants
n=40 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
0 Participants
This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
57 Participants
n=80 Participants • This measurement was not collected on Procedure Team Intervention - Relaxing Environment and Procedure Team - no Intervention Groups
|
|
Insurance type
Private
|
7 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
9 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
0 Participants
This measurement was not collected on Procedure Team Members
|
0 Participants
This measurement was not collected on Procedure Team Members
|
16 Participants
n=80 Participants • This measurement was not collected on Procedure Team Members
|
|
Insurance type
Medicare
|
31 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
29 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
0 Participants
This measurement was not collected on Procedure Team Members
|
0 Participants
This measurement was not collected on Procedure Team Members
|
60 Participants
n=80 Participants • This measurement was not collected on Procedure Team Members
|
|
Insurance type
Medicaid
|
2 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
2 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
0 Participants
This measurement was not collected on Procedure Team Members
|
0 Participants
This measurement was not collected on Procedure Team Members
|
4 Participants
n=80 Participants • This measurement was not collected on Procedure Team Members
|
|
Aromatherapy use
yes
|
11 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
17 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
4 Participants
n=10 Participants • This measurement was not collected on Procedure Team Members
|
3 Participants
n=11 Participants • This measurement was not collected on Procedure Team Members
|
35 Participants
n=101 Participants • This measurement was not collected on Procedure Team Members
|
|
Aromatherapy use
no
|
29 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
23 Participants
n=40 Participants • This measurement was not collected on Procedure Team Members
|
6 Participants
n=10 Participants • This measurement was not collected on Procedure Team Members
|
8 Participants
n=11 Participants • This measurement was not collected on Procedure Team Members
|
66 Participants
n=101 Participants • This measurement was not collected on Procedure Team Members
|
|
Years of Experience in current role
|
—
|
—
|
7.53 years
STANDARD_DEVIATION 9.24 • n=10 Participants • This measurement was not collected for the Subjects acquiring Procedure
|
10.41 years
STANDARD_DEVIATION 10.3 • n=11 Participants • This measurement was not collected for the Subjects acquiring Procedure
|
9.94 years
STANDARD_DEVIATION 9.98 • n=21 Participants • This measurement was not collected for the Subjects acquiring Procedure
|
PRIMARY outcome
Timeframe: Baseline to Minute 30Population: This Measurement was not collected from Procedure Team Members
The VAS for anxiety is a validated scale that ranges from 0-100mm. 0mm is equivalent to "no anxiety" and is located on the left. 100mm is equivalent to "extremely anxious" and is located on the right. The minimum clinically important difference for VAS anxiety is a change of 12mm on a 100mm scale.
Outcome measures
| Measure |
Lavender Aromatherapy Sticker
n=40 Participants
Lavender aromatherapy sticker on patient Calming music from Sirius station 68 (Spa) playing via overhead speakers Overhead lights off, two lanterns lit to provide dim lighting Avoid stirrup use
|
Control - no Intervention
n=40 Participants
Non-aromatic (placebo) sticker on patient No music playing Overhead lights on Stirrups used
|
Procedure Team Intervention - Relaxing Environment
Lavender aromatherapy, calming music, and dim lighting
|
Procedure Team Control - no Intervention
No aromatherapy or music - lights were on
|
|---|---|---|---|---|
|
Mean Change in Visual Analog Scale (VAS) Anxiety Scores
|
-13.8 mm
Standard Deviation 18.1
|
-4.7 mm
Standard Deviation 14.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to post-procedure up to 2 hoursPopulation: This measurement was not collected on Procedure Team Members
Pain during the chemodenervation procedure will be assessed using a visual analog scale for pain. The VAS for pain is a validated scale that ranges from 0-100mm12. 0mm is equivalent to "no pain" and is located on the left. 100mm is equivalent to "worst possible pain" and is located on the right. Subjects are asked to circle a number on the scale that corresponds to their level of pain during the procedure. Baseline scores will be collected on the day of the procedure in the research office after obtaining consent. Patients will then be asked to circle the pain scores that corresponded to the pain experienced during the procedure. This will be collected by study staff after the procedure once the patient is dressed.
Outcome measures
| Measure |
Lavender Aromatherapy Sticker
n=40 Participants
Lavender aromatherapy sticker on patient Calming music from Sirius station 68 (Spa) playing via overhead speakers Overhead lights off, two lanterns lit to provide dim lighting Avoid stirrup use
|
Control - no Intervention
n=40 Participants
Non-aromatic (placebo) sticker on patient No music playing Overhead lights on Stirrups used
|
Procedure Team Intervention - Relaxing Environment
Lavender aromatherapy, calming music, and dim lighting
|
Procedure Team Control - no Intervention
No aromatherapy or music - lights were on
|
|---|---|---|---|---|
|
Mean Change in Visual Analog Scale (VAS) Pain During the Chemodenervation Procedure
|
0.0 mm
Standard Deviation 23.4
|
3.7 mm
Standard Deviation 31.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to post-procedure up to 2 hoursPopulation: This measurement was only collected for Procedure Team Members
Determine if the Relaxing Environment Package decreases procedure staff burnout based on Burnout Battery visual analog scale for healthcare worker burnout. This tool was created to assess the working energy states of healthcare providers and is correlated with the Maslach Burnout Inventory which is a validated 22 question survey regarding workplace burnout14. The clinic staff assigned to chemodenervation procedures as well as the physician performing the procedure will fill out the Burnout Battery VAS at the beginning and end of the clinic day. Providers are asked to circle the battery that represents their current energy level.
Outcome measures
| Measure |
Lavender Aromatherapy Sticker
Lavender aromatherapy sticker on patient Calming music from Sirius station 68 (Spa) playing via overhead speakers Overhead lights off, two lanterns lit to provide dim lighting Avoid stirrup use
|
Control - no Intervention
Non-aromatic (placebo) sticker on patient No music playing Overhead lights on Stirrups used
|
Procedure Team Intervention - Relaxing Environment
n=10 Participants
Lavender aromatherapy, calming music, and dim lighting
|
Procedure Team Control - no Intervention
n=11 Participants
No aromatherapy or music - lights were on
|
|---|---|---|---|---|
|
Procedure Staff Burnout Scores - Burnout Battery Visual Analog Scale for Healthcare Worker Burnout
|
—
|
—
|
-1.73 mm
Standard Deviation 1.78
|
1.31 mm
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: post procedure up to 2 hoursPopulation: This Measurement was not collected from Procedure Team Members
Patient satisfaction with their procedure experience will be assessed using a visual analog scale for patient satisfaction. The VAS for patient satisfaction is a validated scale ranging from 0-100mm. 0mm is equivalent to "no satisfaction" and 100mm is equivalent to "extreme satisfaction". Subjects are asked to circle a number that corresponds to their level of satisfaction with their procedure experience.
Outcome measures
| Measure |
Lavender Aromatherapy Sticker
n=40 Participants
Lavender aromatherapy sticker on patient Calming music from Sirius station 68 (Spa) playing via overhead speakers Overhead lights off, two lanterns lit to provide dim lighting Avoid stirrup use
|
Control - no Intervention
n=40 Participants
Non-aromatic (placebo) sticker on patient No music playing Overhead lights on Stirrups used
|
Procedure Team Intervention - Relaxing Environment
Lavender aromatherapy, calming music, and dim lighting
|
Procedure Team Control - no Intervention
No aromatherapy or music - lights were on
|
|---|---|---|---|---|
|
Patient Satisfaction With Their Procedure Experience Scores
|
91.4 mm
Standard Deviation 16.5
|
89.3 mm
Standard Deviation 19.0
|
—
|
—
|
Adverse Events
Lavender Aromatherapy Sticker
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - no Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Procedure Team Intervention - Relaxing Environment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Procedure Team Control - no Intervention
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