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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Surgery by one of the fellowship trained Urogynecologists at TriHealth
Age >= 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately pre-op
Awards & highlights
Study Summary
This trial studied the effects of a pre-op educational video on reducing patient anxiety before vaginal prolapse surgery.
Who is the study for?
This trial is for English-speaking adults aged 18 or older who are undergoing vaginal prolapse surgery by a Urogynecologist at TriHealth. They must be able to understand and complete a survey, and may also have additional related surgeries. Those with mental disabilities, dementia, Alzheimer's disease, living in nursing homes, or non-English speakers cannot participate.Check my eligibility
What is being tested?
The study is testing if watching an educational video before surgery can reduce anxiety compared to just standard counseling in patients having vaginal prolapse surgery. It aims to see how well patients feel prepared and calm before their procedure.See study design
What are the potential side effects?
Since this trial involves an educational video and standard counseling rather than medical treatments, there are no direct side effects from interventions being studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My surgery will be performed by a specialist at TriHealth.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately pre-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately pre-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pre-operative anxiety level in each group, as measured with the Surgical Anxiety Questionnaire.
Secondary outcome measures
To assess a difference in anxiety levels, based on Surgical Anxiety Questionnaire score, in patients currently taking medication for anxiety
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
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Educational VideoActive Control1 Intervention
An educational video to aid standard counseling packet on post-operative expectations
Group II: Standard of CarePlacebo Group1 Intervention
Standard verbal counseling provided to patients by clinic nurse about post-operative expectations
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Who is running the clinical trial?
TriHealth Inc.Lead Sponsor
95 Previous Clinical Trials
50,820 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and complete a survey on my own.I am 18 years old or older.I do not speak English.My surgery will be performed by a specialist at TriHealth.I am able to understand and answer survey questions despite my condition.I am having a surgery that involves another surgeon too.I may have surgery for other pelvic issues along with my main treatment.I am having or have had surgery to fix pelvic organ prolapse using one of several specific methods.
Research Study Groups:
This trial has the following groups:- Group 1: Educational Video
- Group 2: Standard of Care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently open for this experiment?
"According to the evidence on clinicaltrials.gov, this medical project has halted recruitment and is not presently looking for participants. It was initially published in December of 2022 with its last edit occurring November 21st of that same year. Though no longer seeking candidates, 78 other studies are actively enrolling individuals at this time."
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