Impact of Preop Video on Patient Anxiety

Prolapse; Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633901
• Other study ID #: 22-094
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2022
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: TriHealth Inc.
• Contact: Kelsey Lewis, MD
• Phone: 513-463-4300
• Email: Kelsey_Lewis[@]TriHealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prolapse
• Prolapse, Vaginal
• Prolapse; Female
• Uterine Prolapse

Intervention

Other:
• Educational Video
Patients will be given the link to the educational video and able to view it as many times as they want
• Standard Counseling
Current standard of care verbal counseling from a clinic nurse

Locations

Country	Name	City	State
United States	Cincinnati Urogynecology Associates	Cincinnati	Ohio
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-operative anxiety level in each group, as measured with the Surgical Anxiety Questionnaire.	Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)	Immediately Pre-op
Secondary	To assess a difference in anxiety levels, based on Surgical Anxiety Questionnaire score, in patients currently taking medication for anxiety	Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)	Immediately Pre-op
Secondary	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	Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)	Immediately Pre-op