Clinical trial NCT03379753: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Visual Analog Scale (VAS) Score for Pain
timeFrame: following breakfast on Post-operative day one
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References: