Impact of Preop Video on Patient Anxiety

NCT ID: NCT05633901

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-07

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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Conditions

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Prolapse, Vaginal Prolapse, Uterine Prolapse; Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard of Care

Standard verbal counseling provided to patients by clinic nurse about post-operative expectations

Group Type PLACEBO_COMPARATOR

Standard Counseling

Intervention Type OTHER

Current standard of care verbal counseling from a clinic nurse

Educational Video

An educational video to aid standard counseling packet on post-operative expectations

Group Type ACTIVE_COMPARATOR

Educational Video

Intervention Type OTHER

Patients will be given the link to the educational video and able to view it as many times as they want

Interventions

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Educational Video

Patients will be given the link to the educational video and able to view it as many times as they want

Intervention Type OTHER

Standard Counseling

Current standard of care verbal counseling from a clinic nurse

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cincinnati Urogynecology Associates

Cincinnati, Ohio, United States

Site Status

Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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22-094

Identifier Type: -

Identifier Source: org_study_id

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