NCT06415877

Brief Summary

It was planned as a randomized controlled study to determine the effect of the modified simulation model on self-efficacy, anxiety and academic motivation in episiotomy training. It will be held online with students from the midwifery department of Osmaniye Korkut Ata University.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

21 days

First QC Date

May 9, 2024

Last Update Submit

May 14, 2024

Conditions

EpisiotomyAnxietySimulation

Keywords

episiotomyanxietysimulation

Outcome Measures

Primary Outcomes (1)

  • self-efficacy

    questionnaire

    1 week

Secondary Outcomes (1)

  • academic motivation

    1 week

Study Arms (3)

placebo

PLACEBO COMPARATOR

beef tongue stitched

Other: Episio Training

sham comparator

SHAM COMPARATOR

episio model

Other: Episio Training

experimental group

EXPERIMENTAL

modified tripe coated veal

Other: Episio Training

Interventions

Episio TrainingOTHER

episio repair training

experimental groupplacebosham comparator

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Midwifery student
  • volunteers

You may not qualify if:

  • involuntary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 16, 2024

Study Start

May 30, 2024

Primary Completion

June 20, 2024

Study Completion

June 30, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05