NCT06283537

Brief Summary

Purpose: To determine the effect of online episiotomy simulation training to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence. Method: This study is a randomized controlled experimental study. It will be conducted with third-year students studying at Kastamonu University Midwifery Department in the 2023-2024 period. In the research, all third-year students in the midwifery department (n=60) will be divided into 30 students into the online education group and 30 students into the face-to-face education group using a random sampling model. "Student Information Form", "Episiotomy Skill Evaluation Form" and "Student Satisfaction and Self-Confidence in Learning Scale" will be used to collect data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

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

First Submitted

Initial submission to the registry

February 16, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 16, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

21 days

First QC Date

February 16, 2024

Last Update Submit

March 5, 2025

Conditions

Keywords

EpisiotomyOnline EducationSimulationMidwifery

Outcome Measures

Primary Outcomes (1)

  • episiotomy skill performances

    Is there a difference in episiotomy skill performance between midwifery students receiving online episiotomy simulation training and face-to-face episiotomy simulation training?Episiotomy skill performances will be evaluated with the "Episiotomy Skill Evaluation Form". Possible scores range from 0 to 100, with higher scores indicating higher performance for episiotomy skills. High scores indicate "high skill performance" and low scores indicate "low skill performance."

    4 weeks

Secondary Outcomes (1)

  • Satisfaction with education

    4 weeks

Other Outcomes (1)

  • Self-confidence in learning

    4 weeks

Study Arms (2)

Online episiotomy group

EXPERIMENTAL

30 students will be assigned to the online education group with a random sampling model. To this group; Online episiotomy simulation training will be provided.

Other: Effect of training method

Face to face training group

EXPERIMENTAL

30 students will be assigned to the face-to-face education group with a random sampling model. This group will be given face-to-face episiotomy simulation training in the school environment, which is traditionally applied to the face-to-face training group..

Other: Effect of training method

Interventions

The effect of the training method given to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence.

Face to face training groupOnline episiotomy group

Eligibility Criteria

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

You may qualify if:

  • Wanting to participate in the study voluntarily
  • Having taken the normal birth and postpartum period course
  • Not having any previous episiotomy experience

You may not qualify if:

  • Student wants to leave the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu University

Kastamonu, 37150, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
After all students in the face-to-face education and online education groups complete their applications, the students will practice on the material one by one in the school environment and will be evaluated through the Episiotomy Skill Evaluation Form. In the evaluation, a blinding technique will be used to prevent the person conducting the study interventions from making an evaluation in favor of the intervention group. For this purpose, the faculty member conducting the research initiatives will not take part in the evaluation, instead the evaluation will be made by two different field experts. The experts to be consulted for the evaluation will consist of people working as academicians in the field of obstetrics, nursing and midwifery. After the evaluation, students will have to fill out the survey (Student Information Form) and scale (Student Satisfaction and Self-Confidence in Learning Scale).
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A comparative randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 16, 2024

First Posted

February 28, 2024

Study Start

February 16, 2024

Primary Completion

March 8, 2024

Study Completion

March 15, 2024

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations