NCT07233135

Brief Summary

As part of this research, episiotomy training for third-year midwifery students was transformed into an online video-assisted process due to the pandemic. The aim of the training was to determine the impact of episiotomy repair practice with different materials in a laboratory setting on students' satisfaction and self-confidence and to evaluate the suitability of the simulation design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

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

April 25, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

October 2, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

midwiferyeducationepisiotomysimulationchichen

Outcome Measures

Primary Outcomes (2)

  • Simulation Design Scale

    The scale consists of 20 items and 5 subscales. The Goals and Information subscale consists of 5 items, the Support subscale consists of 4 items, the Problem Solving subscale consists of 5 items, the Feedback/Guided Reflection subscale consists of 4 items, and the Degree of Realism subscale consists of 2 items. The total Cronbach's alpha value for the scale is 0.90. The scale consists of two sections: one for evaluating the simulation model and one for assessing the importance of the simulation design. The first section is rated as "strongly disagree with the statement," "disagree with the statement," "undecided," "agree with the statement," "strongly agree with the statement," and "not applicable." The second section is rated as "not important," "somewhat important," "undecided," "important," and "very important." Scale scores are obtained by dividing the total and subscale scores by the number of items

    Used 5 minutes after the students performed the episiotomy repair, depending on their group.

  • Student Satisfaction-Self-Confidence in Learning Scale

    The scale was developed by Jeffries and Rizzolo (2006) and consists of two subscales: satisfaction with current learning (5 items) and self-confidence in learning (8 items). The scale does not contain any reverse items. Validity and reliability for the Turkish version were conducted by Ünver et al. (2017). The Turkish version of the scale consists of 13 items. It is a five-point Likert-type scale (values range from strongly disagree (1) to strongly agree (5)). The total scale score is obtained by dividing the subscale score by the number of items. A high total score indicates that student satisfaction and self-confidence in learning are high.

    It was used 5 minutes after completing standard training. It was also used 5 minutes after the students performed the episiotomy repair, depending on their group.

Secondary Outcomes (1)

  • Personal Information Form

    Used 5 minutes after completing standard training.

Study Arms (2)

Episiotomy Simulation Model

EXPERIMENTAL

This group received online episiotomy repair training as part of the Normal Birth and Postpartum Term course. The training was delivered as two 60-minute lessons using PowerPoint presentations. The training included a video of episiotomy repair prepared by the researchers. Following the training, the first researcher demonstrated episiotomy repair on a simulation model in a laboratory setting. The students then performed the procedure on chicken breasts.

Other: Episiotomy Simulation Model

Chicken Breast Group

EXPERIMENTAL

This group received online episiotomy repair training as part of the Normal Birth and Postpartum Term course. The training was delivered as two 60-minute lessons using PowerPoint presentations. The training included watching an episiotomy repair video prepared by the researchers. Following the training, the first researcher demonstrated episiotomy repair on a chicken breast in a laboratory setting. The students then performed the procedure on the chicken breast.

Other: Chicken Breast Group

Interventions

Chicken breast is dead animal tissue that can be used to practice repairing lacerations or episiotomies following vaginal delivery. The chicken breast was used. The impact of working with this model on students' satisfaction and self-confidence was investigated, and its suitability for simulation was evaluated.

Chicken Breast Group

The Episiotomy Simulation Model provides a realistic tool for practicing the care and repair of lacerations or apisiotomies following vaginal delivery. The impact of working with this model on students' satisfaction and self-confidence was investigated, and the suitability of the simulation was evaluated.

Episiotomy Simulation Model

Eligibility Criteria

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

You may qualify if:

  • Third-year midwifery students who volunteered to participate in the study,
  • were taking a course on normal birth and the postpartum period for the first time, had no experience with episiotomy repair, and had not previously observed an episiotomy repair procedure, were included in the study.

You may not qualify if:

  • Students who were absent on the day the episiotomy topic was taught.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, Tokat Province, 60000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Doctor

Study Record Dates

First Submitted

October 2, 2025

First Posted

November 18, 2025

Study Start

April 25, 2021

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations