NCT03701347

Brief Summary

This randomized controlled trial evaluates the learning effectiveness of three different types of Colposcopy simulators objectively with Objective Structured Assessment of Technical Skill (OSATS) and subjectively with self-reported confidence survey. A total of 60 participants, randomly assigned into 3 groups, will learn from Hefler's, Reeve's or authors' simulators. The investigators hypothesize that the proposed simulator affords better learning objectively and subjectively with improved functional fidelity.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 29, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 30, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

October 12, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 30, 2018

Last Update Submit

October 10, 2018

Conditions

Colposcopy

Keywords

ColposcopySimulatorComparison StudyLearning effectiveness

Outcome Measures

Primary Outcomes (2)

  • OSATS Score

    Objective structured assessment of technical skills (OSATS) scores rose before and after completion of training Competency Scale. Score of 2 indicates participant can performed task independently.Score of 1 indicates participant need help performing task. Score of 0 indicates participant has not performed the task. 1. Use of speculum 2. Using Colposcope for good visualization of area to be excised. 3. Infiltration of local anaesthetic: adrenaline circumferentially around lesion to be 4. excised using the dental syringe provided. 5. Perform LEEP in 1 single pass producing 1 specimen only.

    10 minutes

  • Self-reported confidence score

    Likert scale of 1 to 5. Score of 1 indicates very low confidence whereas a score of 5 indicates high confidence at performing the procedures.

    1 minute

Secondary Outcomes (1)

  • Quality of specimen

    10 minutes

Study Arms (3)

Reeve's model

ACTIVE COMPARATOR

After introduction of Loop excision electrosurgical procedure through video, participants will undergo Reeve's simulators

Device: Reeve's model

Hefler's model

ACTIVE COMPARATOR

After introduction of Loop excision electrosurgical procedure through video, participants will undergo Hefler's simulators

Device: Hefler's model

Ida's Model

EXPERIMENTAL

After introduction of Loop excision electrosurgical procedure through video, participants will undergo Ida's simulators

Device: Ida's model

Interventions

Reeve's modelDEVICE

Reeves, K. O., Young, A. E., \& Kaufman, R. H. (1999). A simple, inexpensive device for teaching the loop electrosurgical excision procedure. Obstetrics and Gynecology, 94(3), 474-5.

Reeve's model
Hefler's modelDEVICE

Hefler, L., Grimm, C., Kueronya, V., Tempfer, C., Reinthaller, A., \& Polterauer, S. (2012). A novel training model for the loop electrosurgical excision procedure: An innovative replica helped workshop participants improve their LEEP. American Journal of Obstetrics and Gynecology, 206(6)

Hefler's model
Ida's modelDEVICE

Reusable, portable and modular 3D printed simulator

Ida's Model

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Year 4 and Year 5 Medical students who have completed their Obstetrics and gynaecology attachment
  • Practicing medical doctors who have and have not performed Colposcopy LEEP

You may not qualify if:

  • Students who have not completed their Obstetrics and gynaecology attachment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics & Gyanecology

Singapore, Singapore

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

September 30, 2018

First Posted

October 10, 2018

Study Start

September 29, 2018

Primary Completion

September 30, 2020

Study Completion

December 30, 2020

Last Updated

October 12, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)