Postoperative Environment on Pain Following Pelvic Reconstructive Surgery

Postoperative Pain Clinical Trial

Official title:

The Influence of Postoperative Environment on Patient Satisfaction and Perception of Care Following Pelvic Reconstructive Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379753
• Other study ID #: 17-076
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2021
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 20, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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