Impact of Preop Video on Patient Anxiety

November 21, 2024 updated by: TriHealth Inc.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital
      • Cincinnati, Ohio, United States, 45220
        • Cincinnati Urogynecology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Immediately Pre-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess a difference in anxiety levels, based on Surgical Anxiety Questionnaire score, in patients currently taking medication for anxiety
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)
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
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)
Immediately Pre-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Actual)

November 6, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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