NCT02664025

Brief Summary

Teaching technical skills during medical training can lead to some issues, which can concern ethical or medico-legal risks. In this context, the vaginal examination (VE) is specific because it concerns the genital area and it interferes with obstetrical management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

January 22, 2016

Last Update Submit

September 6, 2016

Conditions

Healthy

Keywords

teaching vaginal examination

Outcome Measures

Primary Outcomes (1)

  • the improvement of vaginal examination accuracy score after practical training on simulators

    5 minutes

Study Arms (2)

simulation group

ACTIVE COMPARATOR

Interns will carry out 10 VE on a simulator

Procedure: vaginal examination simulator

Control group

NO INTERVENTION

Interns who will not perform any simulated VE

Interventions

vaginal examination simulatorPROCEDURE
simulation group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Interns who finished their study in faculty of medicine
  • Interns who never performed VE before
  • Interns who accept to participate in the study

You may not qualify if:

  • Interns who refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 26, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Locations

EG(1)