Postoperative Environment on Pain Following Pelvic Reconstructive Surgery

NCT ID: NCT03379753

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2019-12-20

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.

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 patient's outcome and perception of healing.

Literature review reveals efforts by both medical and design teams towards improving the experience of the patient and developing an environment that promotes healing. Changes to the physical environment have been shown to have an impact on satisfaction. These parameters have included music and art. Considering the effort that is now going into improving the patient experience and developing this theory of healing spaces, there has yet to be a randomized controlled trial evaluating these alternative therapies in the urogynecologic patient population. Although each of these modalities appears beneficial, we believe that a combination of these would be even more useful. Indeed, these treatments are also relatively easy to implement without undue cost or burden to the hospital. This study seeks to determine the influence of applying music and art to the post operative environment for patients recovering from major urogynecologic surgery on pain.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

music and positive images

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Pauls, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth - Cincinnati Urogynecology Associates

Locations

Good Samaritan Hospital

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-076

Identifier Type: -

Identifier Source: org_study_id