Impact of Preop Video on Patient Anxiety

Not Applicable

Active, not recruiting

• Conditions: Prolapse, Uterine; Prolapse; Female; Prolapse, Vaginal
• Interventions: Other: Educational Video; Other: Standard Counseling

• Registration Number: NCT05633901
• Lead Sponsor: TriHealth Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-12-01
• Study Start: 2022-12-07
• Status Verified: 2024-11
• Primary Completion: 2024-11-06
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational Video	Educational Video	An educational video to aid standard counseling packet on post-operative expectations
Standard of Care	Standard Counseling	Standard verbal counseling provided to patients by clinic nurse about post-operative expectations

Primary Outcome Measures

Name	Time	Method
Pre-operative anxiety level in each group, as measured with the Surgical Anxiety Questionnaire.	Immediately Pre-op	Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)

Secondary Outcome Measures

Name	Time	Method
To assess a difference in anxiety levels, based on Surgical Anxiety Questionnaire score, in patients currently taking medication for anxiety	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 that did or did not watch the video at home	Immediately Pre-op	Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)

Trial Locations

Locations (2)

Cincinnati Urogynecology Associates; 🇺🇸 Cincinnati, Ohio, United States

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States