Postoperative Environment on Pain Following Pelvic Reconstructive Surgery

NCT03379753 | Completed Results

• 1 other identifier: 17-076
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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 to discharge when exposed to the diad of music and positive images compared to patients receiving standard care.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) Score for Pain

  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.

  following breakfast on Post-operative day one

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: music and positive images

Control group

NO INTERVENTION

Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment.

Interventions

music and positive images OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Rachel Pauls, MD
• Organization: TriHealth Inc.

Rachel_Pauls@trihealth.com

513-463-4300

Study Officials

• Rachel Pauls, MD

  TriHealth - Cincinnati Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 20, 2017
• Study Start: May 2, 2018
• Primary Completion: June 26, 2019
• Study Completion: December 20, 2019
• Last Updated: January 6, 2021
• Results First Posted: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)