Status:

COMPLETED

Postoperative Environment on Pain Following Pelvic Reconstructive Surgery

Lead Sponsor:

TriHealth Inc.

Conditions:

Postoperative Pain

Eligibility:

FEMALE

18-85 years

Phase:

NA

Brief 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...

Detailed Description

Over the past decade, interest has grown in improving the patient experience. As part of this movement, studies have sought to evaluate the mechanisms by which the postoperative environment affects a ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 2 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 20 2019

Estimated Enrollment :

132 Patients enrolled

Trial Details

Trial ID

NCT03379753

Start Date

May 2 2018

End Date

December 20 2019

Last Update

January 6 2021

Active Locations (1)

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1

Good Samaritan Hospital

Cincinnati, Ohio, United States, 45220