Impact of Preop Video on Patient Anxiety
Evaluation of Preoperative Counseling Video on Anxiety in Patients Undergoing Vaginal Prolapse Surgery
1 other identifier
interventional
160
1 country
2
Brief Summary
To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2022
CompletedFirst Posted
Study publicly available on registry
December 1, 2022
CompletedStudy Start
First participant enrolled
December 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedNovember 22, 2024
November 1, 2024
1.9 years
November 7, 2022
November 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
To assess a difference in anxiety levels, based on Surgical Anxiety Questionnaire score, in patients currently taking medication for anxiety
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
Immediately Pre-op
Study Arms (2)
Standard of Care
PLACEBO COMPARATORStandard verbal counseling provided to patients by clinic nurse about post-operative expectations
Educational Video
ACTIVE COMPARATORAn educational video to aid standard counseling packet on post-operative expectations
Interventions
Patients will be given the link to the educational video and able to view it as many times as they want
Current standard of care verbal counseling from a clinic nurse
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TriHealth Inc.lead
Study Sites (2)
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2022
First Posted
December 1, 2022
Study Start
December 7, 2022
Primary Completion
November 6, 2024
Study Completion
December 1, 2024
Last Updated
November 22, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share