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Postoperative Environment on Pain Following Pelvic Reconstructive Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
music and positive images
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Good Samaritan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2017
Last Updated
January 4, 2021
Sponsor
TriHealth Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03379753
Brief Title
Postoperative Environment on Pain Following Pelvic Reconstructive Surgery
Official Title
The Influence of Postoperative Environment on Patient Satisfaction and Perception of Care Following Pelvic Reconstructive Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Those patients randomized to control group will receiving standard care in a private hospital room with an un-modified post operative environment.
Intervention Type
Other
Intervention Name(s)
music and positive images
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Score for Pain
Description
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.
Time Frame
following breakfast on Post-operative day one

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Pauls, MD
Organizational Affiliation
TriHealth - Cincinnati Urogynecology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postoperative Environment on Pain Following Pelvic Reconstructive Surgery

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