NCT05633901Active, not recruitingNot Applicable
Evaluation of Preoperative Counseling Video on Anxiety in Patients Undergoing Vaginal Prolapse Surgery
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- TriHealth Inc.
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Pre-operative anxiety level in each group, as measured with the Surgical Anxiety Questionnaire.
Study Overview
Brief Summary
To determine whether a pre-operative educational video has an impact on the anxiety of patients undergoing vaginal prolapse surgery
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Standard of Care
Placebo Comparator
Standard verbal counseling provided to patients by clinic nurse about post-operative expectations
Intervention: Standard Counseling (Other)
Educational Video
Active Comparator
An educational video to aid standard counseling packet on post-operative expectations
Intervention: Educational Video (Other)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Unknown
Not Applicable
The Impact of Video Information on Preoperative Anxiety in Interventional Cardiology Patients.Atrial FlutterCoronary Artery DiseaseAtrial FibrillationNCT04473495Central Hospital, Nancy, France74
Unknown
Not Applicable
Effects of Video Information on Preoperative Anxiety in Patients With Colorectal CancerVideo InformationColorectal CancerNCT02873455Seoul National University Hospital32
Completed
Not Applicable
Effect of a PReoperative Information Video on Anxiety in Deep Brain Stimulation surgery patientspre-operatieve angstpreoperative anxiety in Parkinson's disease patients1002803710009720NL-OMON37791Academisch Medisch Centrum40
Completed
Not Applicable
Educational Video and Peri-operative AnxietyAnxiety DisordersAmbulatory Surgical ProceduresNCT03581097University Hospital, Geneva93
Completed
Phase 3
The effect of educational video on preoperative anxiety in patients with cataractAnxiety of patients undergoing cataract surgery.IRCT20200115046145N1Islamic Azad University160