Evaluation of Preoperative Counseling Video on Anxiety in Patients Undergoing Vaginal Prolapse Surgery

TriHealth Inc.2 sites in 1 country160 target enrollmentDecember 7, 2022

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prolapse, Vaginal
Sponsor: TriHealth Inc.
Enrollment: 160
Locations: 2
Primary Endpoint: Pre-operative anxiety level in each group, as measured with the Surgical Anxiety Questionnaire.
Status: Active, not recruiting
Last Updated: last year

To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery

Registry

clinicaltrials.gov

Start Date

December 7, 2022

End Date

December 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Sponsor

Responsible Party

Sponsor

•Prolapse surgery may include: apical repair with uterosacral ligament suspension, or sacrospinous/iliococcygeal ligament fixation, or sacrocolpopexy.
•They may also have a concomitant total vaginal hysterectomy with or without bilateral salpingectomy/oophorectomy, other compartment repairs for prolapse, or a suburethral sling for incontinence.
•Surgery by one of the fellowship trained Urogynecologists at TriHealth
•Age \>= 18
•English speaking
•Able to comprehend and answer the survey completely.

•Concomitant procedure with another surgeon
•Resides in a nursing home
•Non-English speaking
•Patients with mental disability, Alzheimer's disease, dementia that would preclude complete answering of the survey or inability to answer the questions.

Pre-operative anxiety level in each group, as measured with the Surgical Anxiety Questionnaire.

Time Frame: Immediately Pre-op

Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)

To assess a difference in anxiety levels, based on Surgical Anxiety Questionnaire score, in patients currently taking medication for anxiety(Immediately Pre-op)
To assess a difference in anxiety levels, based on Surgical Anxiety Questionnaire score, in patients that did or did not watch the video at home(Immediately Pre-op)