Impact of Preop Video on Patient Anxiety

Sponsor

TriHealth Inc. (Other)

Overall Status

Recruiting

CT.gov ID

NCT05633901

Collaborator

(none)

148

Enrollment

Locations

Arms

14.8

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prolapse, Vaginal Prolapse, Uterine Prolapse; Female	Other: Educational Video Other: Standard Counseling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 7, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Standard of Care Standard verbal counseling provided to patients by clinic nurse about post-operative expectations	Other: Standard Counseling Current standard of care verbal counseling from a clinic nurse
Active Comparator: Educational Video An educational video to aid standard counseling packet on post-operative expectations	Other: Educational Video Patients will be given the link to the educational video and able to view it as many times as they want

Arm

Intervention/Treatment

Placebo Comparator: Standard of Care

Standard verbal counseling provided to patients by clinic nurse about post-operative expectations

Other: Standard Counseling

Current standard of care verbal counseling from a clinic nurse

Active Comparator: Educational Video

An educational video to aid standard counseling packet on post-operative expectations

Other: Educational Video

Patients will be given the link to the educational video and able to view it as many times as they want

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.