NCT05540379

Brief Summary

Evaluation the efficacy of Virtual Reality simulator training in improving basic gynecological hysteroscopic skills and assess training levels in Ob/Gyn residents, as compared to others with previous hysteroscopic experience.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

11 months

First QC Date

September 9, 2022

Last Update Submit

September 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Virtual Reality Training Score

    • To compare the final score achieved by the physicians who had performed less than 50 diagnostic hysteroscopies and hysteroscopic polypectomy after 3 training sessions on VR hysteroscopy simulator with the score achieved by physicians who had performed at least 50 diagnostic hysteroscopies and hysteroscopic polypectomy to ensure the role of VR in training for hysteroscopic polypectomy.

    from baseline to 6 months after the trainig

Study Arms (2)

Group A: Ob/Gyn physicians

ACTIVE COMPARATOR

It is about 51 participants whom had performed less than 50 diagnostic hysteroscopies and hysteroscopic polypectomy.

Device: Virtual Reality Training

Group B: Ob/Gyn physicians

ACTIVE COMPARATOR

It is about 51 participants whom had performed at least 50 diagnostic hysteroscopies and hysteroscopic polypectomy.

Device: Virtual Reality Training

Interventions

Training the obstetrics and Gynecologist Residents on Virtual endoscopic simulation and skills acquisition

Group A: Ob/Gyn physiciansGroup B: Ob/Gyn physicians

Eligibility Criteria

Age26 Years - 36 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Residents, assistant lecturers, lecturers, associate professors and professors in Ob/Gyn department.
  • Group A: Ob/Gyn physicians who had performed less than 50 diagnostic hysteroscopies and hysteroscopic polypectomy.
  • Group B: Ob/Gyn physicians who had performed at least 50 diagnostic hysteroscopies and hysteroscopic polypectomy.

You may not qualify if:

  • Physicians who had previously attended VR simulator training course

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine - Cairo University

Giza, Egypt

Location

Study Officials

  • Ahmed M Fawzi El-Minawi, Professor

    Department of obstetrics and gynecology, Faculty Of Medicine, Cairo University

    STUDY CHAIR
  • Nadine A Sherif, Professor

    Department of obstetrics and gynecology, Faculty Of Medicine, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: the efficacy of VR simulator training in improving basic gynecological hysteroscopic skills
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 14, 2022

Study Start

May 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 30, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations