Trial Outcomes & Findings for Postoperative Environment on Pain Following Pelvic Reconstructive Surgery (NCT NCT03379753)
NCT ID: NCT03379753
Last Updated: 2021-01-06
Results Overview
VAS score for pain administered following breakfast on post-operative day one. The VAS was100 millimeter (mm) scale with 'no pain' on the far left represented as 0 mm and 'most pain' on the far right equating to 100 mm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
following breakfast on Post-operative day one
Results posted on
2021-01-06
Participant Flow
Participant milestones
| Measure |
Intervention Group
Those patients randomized to intervention group will be exposed to the diad of music and positive images in a private hospital room in addition to receiving standard care.
music and positive images: The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room.
|
Control Group
Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
71
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
15
|
25
|
Reasons for withdrawal
| Measure |
Intervention Group
Those patients randomized to intervention group will be exposed to the diad of music and positive images in a private hospital room in addition to receiving standard care.
music and positive images: The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room.
|
Control Group
Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
not having correct procedure
|
1
|
2
|
|
Overall Study
No primary outcome
|
12
|
22
|
Baseline Characteristics
Postoperative Environment on Pain Following Pelvic Reconstructive Surgery
Baseline characteristics by cohort
| Measure |
Intervention Group
n=46 Participants
Those patients randomized to intervention group will be exposed to the diad of music and positive images in a private hospital room in addition to receiving standard care.
music and positive images: The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room.
|
Control Group
n=46 Participants
Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 9.4 • n=99 Participants
|
63.6 years
STANDARD_DEVIATION 9.6 • n=107 Participants
|
63.8 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
44 participants
n=99 Participants
|
43 participants
n=107 Participants
|
87 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=99 Participants
|
46 participants
n=107 Participants
|
92 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: following breakfast on Post-operative day oneVAS score for pain administered following breakfast on post-operative day one. The VAS was100 millimeter (mm) scale with 'no pain' on the far left represented as 0 mm and 'most pain' on the far right equating to 100 mm.
Outcome measures
| Measure |
Intervention Group
n=46 Participants
Those patients randomized to intervention group will be exposed to the diad of music and positive images in a private hospital room in addition to receiving standard care.
music and positive images: The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room.
|
Control Group
n=46 Participants
Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment.
|
|---|---|---|
|
Visual Analog Scale (VAS) Score for Pain
|
28.0 millimeter (mm)
Interval 0.0 to 86.0
|
24.5 millimeter (mm)
Interval 0.0 to 81.0
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control 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