Postoperative Environment on Pain Following Pelvic Reconstructive Surgery

Completed · Not applicable

Conditions studied: Postoperative Pain

In brief

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.

Key facts

Study ID

NCT03379753

Run by

TriHealth Inc.

People needed

132

Starts

2018-05-02

Expected to finish

2019-12-20

Last updated by the study team

2021-01-06

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Good Samaritan Hospital — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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