Back to resultsImpact of Preop Video on Patient Anxiety
Primary Purpose
Prolapse, Vaginal, Prolapse, Uterine, Prolapse; Female
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Video
Standard Counseling
Sponsored by
About this trial
This is an interventional prevention trial for Prolapse, Vaginal focused on measuring Anxiety, Video, Prolapse, Urogynecology
Eligibility Criteria
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.
Sites / Locations
- Cincinnati Urogynecology AssociatesRecruiting
- Good Samaritan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Standard of Care
Educational Video
Arm Description
Standard verbal counseling provided to patients by clinic nurse about post-operative expectations
An educational video to aid standard counseling packet on post-operative expectations
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05633901
Brief Title
Impact of Preop Video on Patient Anxiety
Official Title
Evaluation of Preoperative Counseling Video on Anxiety in Patients Undergoing Vaginal Prolapse Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse, Vaginal, Prolapse, Uterine, Prolapse; Female
Keywords
Anxiety, Video, Prolapse, Urogynecology
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Placebo Comparator
Arm Description
Standard verbal counseling provided to patients by clinic nurse about post-operative expectations
Arm Title
Educational Video
Arm Type
Active Comparator
Arm Description
An educational video to aid standard counseling packet on post-operative expectations
Intervention Type
Other
Intervention Name(s)
Educational Video
Intervention Description
Patients will be given the link to the educational video and able to view it as many times as they want
Intervention Type
Other
Intervention Name(s)
Standard Counseling
Intervention Description
Current standard of care verbal counseling from a clinic nurse
Primary Outcome Measure Information:
Title
Pre-operative anxiety level in each group, as measured with the Surgical Anxiety Questionnaire.
Description
Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)
Time Frame
Immediately Pre-op
Secondary Outcome Measure Information:
Title
To assess a difference in anxiety levels, based on Surgical Anxiety Questionnaire score, in patients currently taking medication for anxiety
Description
Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)
Time Frame
Immediately Pre-op
Title
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
Description
Surgical Anxiety Questionnaire is a validated, 17 question survey with scores ranging from 0 (least anxious) to 68 (most anxious)
Time Frame
Immediately Pre-op
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelsey Lewis, MD
Phone
513-463-4300
Email
Kelsey_Lewis@TriHealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Yeung, DO
Facility Information:
Facility Name
Cincinnati Urogynecology Associates
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Hodge, RN
Phone
513-463-4300
Email
Jennifer_Hodge2@trihealth.com
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catrina C Crisp, MD
Phone
513-862-4171
Email
catrina_crisp@trihealth.com
First Name & Middle Initial & Last Name & Degree
Catrina C Crisp, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Preop Video on Patient Anxiety
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