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Behavioural Intervention

Simulation Training for Vaginal Hysterectomy Skills

N/A

Recruiting

Led By Leslie Kammire, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Residents have performed two or fewer vaginal hysterectomies

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 2

Awards & highlights

Study Summary

This trial will test whether simulation training with the Miya Model improves Operating Room performance of Vaginal Hysterectomy (VH) in novice surgeons.

Who is the study for?

This trial is for novice surgeons who are residents at participating institutions and have performed two or fewer vaginal hysterectomies. It's not open to those who've had dedicated training in this procedure or have done three or more such surgeries in the operating room.Check my eligibility

What is being tested?

The study is testing whether practicing with a simulation tool called the Miya Model can improve the performance of novice surgeons during actual vaginal hysterectomy operations in the operating room.See study design

What are the potential side effects?

Since this trial involves educational simulation rather than medical treatment, there aren't direct side effects like you'd expect from drugs. However, participants may experience stress or fatigue related to learning new surgical techniques.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have performed two or fewer vaginal hysterectomies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Vaginal Surgical Skills Index (VSSI) scores - Control Group

Vaginal Surgical Skills Index (VSSI) scores - Intervention Group

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention

Participants will receive standardized training by performing five hysterectomies on the Miya Model with a trainer who is a sub-PI at each Institution, with each of these training sessions filmed and then scored by blinded experts - Residents in the simulation arm will train until they reach a score of 27 on the modified Vagina Surgical Skills Index (VSSI)

Group II: Control groupActive Control1 Intervention

The training will be whatever is standard at their Institution

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,656 Total Patients Enrolled

Leslie Kammire, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Miyamodel Training (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05418764 — N/A

Vaginal Hysterectomy Research Study Groups: Control group, Intervention group

Vaginal Hysterectomy Clinical Trial 2023: Miyamodel Training Highlights & Side Effects. Trial Name: NCT05418764 — N/A

Miyamodel Training (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05418764 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the inclusion criteria for this experiment limited to seniors aged 75 and up?

"To qualify for this medical trial, an individual must be 18 years or older and not exceed 80."

Answered by AI

Who has the opportunity to participate in this experiment?

"This trial is recruiting 70 individuals with a history of vaginal hysterectomy between the ages 18 to 80. In order to be eligible, participants must reside at one of the participating Institutions and have completed no more than two instances of this specific procedure."

Answered by AI

What is the current number of participants enrolled in this clinical experiment?

"Indeed, the information on clinicialtrials.gov shows that this trial is still recruiting participants. This medical research was initially published on December 27th 2021 and was recently modified August 26th 2022. 70 people need to be enrolled from 1 specified centre."

Answered by AI

Are participants still being accepted into the experiment?

"As confirmed by clinicaltrials.gov, this study is actively seeking volunteers; the initial posting was published on December 27th 2021 and the data were most recently refreshed on August 26th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Validated Skills Simulation With the Miya Model

2021. "Effect of Validated Skills Simulation With the Miya Model". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05418764.