NCT06348680

Brief Summary

The goal of midwifery undergraduate education is; To provide students with basic professional knowledge, skills and attitudes in cognitive, affective and psychomotor dimensions. Various practices are used to provide students with midwifery skills. Case studies, maintenance processes, laboratory applications, field studies, simulation application and video monitoring are some of these applications. Each of these approaches, which are especially preferred in applied courses, has an important place in increasing students' self-efficacy and reducing their anxiety. Episiotomy is one of the obstetric interventions that negatively affects the self-efficacy of midwifery students and causes anxiety. Midwives are responsible for performing and caring for episiotomy. In many countries, episiotomy repair training is given to midwifery students using sponges or models. However, today the use of calf tongue, which is very similar to perineal tissue, has become widespread. There are a limited number of studies in the literature using calf tongue simulation. These studies suggested that the practice improved the skills of midwifery students. No study has been found in the literature using video-assisted episiotomy repair training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 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

March 25, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 25, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

11 days

First QC Date

March 25, 2024

Last Update Submit

February 21, 2025

Conditions

Keywords

EpisiotomySelf-efficacyMidwifery Students

Outcome Measures

Primary Outcomes (2)

  • State Anxiety Scale

    Scoring is as follows: "1=Not at all, 2=Somewhat, 3=A lot and 4=Completely." There are two types of expressions in the scale: direct and reverse. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 are scored in reverse. Direct expressions express negative emotions; Inverted expressions contain positive emotions. The scores obtained from the scale theoretically range between 20 and 80. High scores from the scale indicate high anxiety level, low scores indicate low anxiety level.

    through study completion, an average of 1 year

  • Episiotomy Skills Self-Efficacy Scale

    The scale consists of 19 items and two subscales: 'episiotomy preparation and application' and 'episiotomy control'. For each item on the Likert-type scale, "1" is given for the "strongly disagree" response, "2" is given for the "disagree" response, "3" is given for the "agree" response, and "4" is given for the "strongly agree" response. There are no reverse coded items in the scale. The total score varies between 19 and 76. High scores from the scale indicate a high level of self-efficacy for episiotomy skills.

    through study completion, an average of 1 year

Study Arms (2)

Experimental group

EXPERIMENTAL

Standard episiotomy repair training will be given to the students in the experimental group using the calf tongue simulator. After the theoretical phase is completed, the implementation phase will begin. During the application period (practical phase), students in this group will be shown a 'video recording' of episiotomy repair prepared by the researchers as educational material. Thus, students in the experimental group will be able to watch episiotomy repairs whenever and however many times they want, in addition to researcher support throughout the application, and improve their application skills.

Other: Video assisted episiotomy repair training

Control group

NO INTERVENTION

Students in the control group will be given standard episiotomy repair training using the calf tongue simulator. After the theoretical phase is completed, the implementation phase will begin. Researcher support will be provided throughout the implementation period.

Interventions

Midwifery Intervention The 'video recording' prepared by researchers specialized in the field of midwifery to increase the episiotomy repair skills of midwifery students will be used as training material. The content of the video recording is as follows: control before episiotomy repair, episiotomy repair, subcutaneous suturing, skin suturing, suturing techniques (Continuous, Simple Intermittent, Mattress). After the video recording is completed, it will be restarted and shown to the students in the experimental group continuously throughout the application period. At the end of the application period, students will be re-evaluated.

Experimental group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Midwifery students who are studying in the 3rd year, have taken the normal birth and postpartum period course and are registered for the risky birth and postpartum period course
  • Those who volunteer to participate in the study

You may not qualify if:

  • Those who did not agree to participate in the research
  • Those who have an active working life as midwives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University

Amasya, Center, 05000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 5, 2024

Study Start

March 25, 2024

Primary Completion

April 5, 2024

Study Completion

May 15, 2024

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations