N/A
N=132
Postoperative Environment on Pain Following Pelvic Reconstructive Surgery
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT03379753 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Visual Analog Scale (VAS) Score for Pain — 28.0; 24.5 millimeter (mm) — p=0.57
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- music and positive images (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- TriHealth Inc.
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) Score for Pain |
28.0; 24.5 | 0.57 |
Summary
This study is to determine if patients following prolapse repair including vaginal vault suspension have decreased pain measured via a visual analog scale (VAS) on postoperative day one and just prior to discharge when exposed to the diad of music and positive images compared to patients receiving standard care.
Eligibility Criteria
Inclusion Criteria
- Adults 18-85 years of age
- English speaking
- Undergoing surgery for pelvic organ prolapse to include an apical vaginal vault suspension by a physician at Cincinnati Urogynecology Associates, TriHealth
- Concomitant procedures such as hysterectomy, suburethral sling, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy will be included
- Ability to complete the questionnaires and provide consent
- Willingness to listen to music at the minimum recommended time intervals
Exclusion Criteria
- Unwillingness to participate in the study
- Physical or mental impairment that would affect the subject's ability to utilize the modified environment such as deafness, blindness or dementia
- Patients who take daily narcotics or NSAIDS
- Patients with history of Drug or Alcohol Abuse
- Patients with chronic pain syndromes
- Non English speaking
- Patients that do not undergo a vaginal apical suspension procedure
Data sourced from ClinicalTrials.gov (NCT03379753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.