NCT07804108

Brief Summary

Objective: The aim of this study is to evaluate the effect of mosaic art in midwifery education on episiotomy repair performance, self-efficacy, and anxiety: a randomized controlled trial. Method/Data Collection Techniques: The study was planned in a two-parallel-group randomized controlled experimental design including pre-test and post-test measurements. The study will be conducted with third-year students studying in the Midwifery Department of the Faculty of Health Sciences at Kahramanmaraş Sütçü İmam University during the fall semester of the 2026-2027 academic year. The sample size was calculated using the G\*Power 3.1.9.7 program, and based on Cohen's effect size d=0.55, α=0.05, and 80% power, a total of 106 students were planned to be included in the study, with 53 students in each group. Participants will be assigned to intervention and control groups using a simple randomization method. The intervention group will receive structured mosaic art training for six weeks, with two sessions per week, while the control group will not receive any art-based application during this period. Following the intervention, both groups will receive theoretical and practical training in standard episiotomy repair. Data will be collected using the Participant Information Form, State Anxiety Scale (STAI-TX I), Episiotomy Self-Efficacy Scale, Attitudes Towards Learning Scale, and Episiotomy Repair Skill Assessment Form. Appropriate descriptive statistics and parametric or non-parametric comparison tests will be used in the analysis of the data, with a statistical significance level of p\<0.05. Expected Results: This research is expected to provide scientific evidence regarding the use of art-based teaching methods in midwifery education by revealing the effect of mosaic art application on midwifery students' episiotomy repair skills, self-efficacy, attitudes towards learning, and state anxiety levels. It is anticipated that the research results will contribute to the development of effective teaching strategies in psychomotor skills training and the strengthening of midwifery education programs.

Trial Health

65
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Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Sep 2026

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

Study Progress7%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

August 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

September 28, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 4, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 27, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

Mosaic ArtMidwifery StudentsEpisiotomy RepairAnxietyimulation-Based Education

Outcome Measures

Primary Outcomes (2)

  • Episiotomy Self-Efficacy

    Episiotomy self-efficacy will be assessed using the Episiotomy Self-Efficacy Scale developed by Yolcu et al. (2025). The scale consists of 17 items across four subdimensions: cognitive (5 items), affective (5 items), motivation (3 items), and psychomotor (4 items). Each item is rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). There are no reverse-scored items. The total score ranges from 17 to 85, with higher scores indicating greater episiotomy self-efficacy.

    Immediately before and immediately after the episiotomy repair training

  • Episiotomy Repair Skill Performance

    Episiotomy repair skill performance will be assessed using the Episiotomy Repair Skill Assessment Form developed by the researchers based on the relevant literature and expert review. The form consists of 20 procedural steps assessing the performance of

    Baseline and immediately post-intervention

Secondary Outcomes (2)

  • State Anxiety (STAI Form TX-I)

    Baseline and immediately post-intervention

  • Attitudes Toward Learning

    Baseline and immediately post-intervention

Study Arms (2)

Mosaic Art Group

EXPERIMENTAL

Participants in this group will receive the planned mosaic art intervention before episiotomy repair training. The mosaic art program will be conducted for 6 weeks, with two 45-minute sessions per week. Following the intervention, participants will receive the standard theoretical and practical episiotomy repair training.

Behavioral: Mosaic Art PracticeBehavioral: Standard Episiotomy Repair Training

Control Group

ACTIVE COMPARATOR

Participants in the control group will not receive the mosaic art intervention. They will receive the same standard theoretical and practical episiotomy repair training as the intervention group

Behavioral: Standard Episiotomy Repair Training

Interventions

Participants assigned to the intervention group will participate in a structured mosaic art program for six weeks before episiotomy repair training. The program will consist of two 45-minute sessions per week (12 sessions in total). Participants will engage in mosaic art activities requiring coordinated hand and finger movements and fine motor control. After completion of the mosaic art program, participants will receive the same theoretical and practical episiotomy repair training provided to the control group.

Mosaic Art Group

Participants will receive standardized theoretical and practical episiotomy repair training. The training will include 2 hours of theoretical instruction and 6 hours of practical training using a silicone episiotomy repair model. The same standardized episiotomy repair training will be provided to participants in both study groups.

Control GroupMosaic Art Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being enrolled as a third-year student in the Department of Midwifery, Faculty of -Health Sciences, Kahramanmaraş Sütçü İmam University, during the Fall -semester of the 2026-2027 academic year.
  • Volunteering to participate in the study.
  • Providing written informed consent.
  • Having no previous clinical practice experience in episiotomy repair.
  • Having no previous participation in a structured training program involving mosaic art or similar activities requiring fine motor skills.

You may not qualify if:

  • Having previous clinical practice experience in episiotomy repair.
  • Having previously participated in a structured mosaic art training program or a similar structured program requiring fine motor skills.
  • Having a condition that prevents participation in the mosaic art activities or episiotomy repair simulation practice.
  • Declining or withdrawing consent to participate in the study

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
OUTCOMES ASSESSOR
Masking Details
The outcome assessor evaluating episiotomy repair performance will be blinded to the participants' group assignments. Due to the nature of the mosaic art intervention, participants and the researchers administering the intervention cannot be blinded
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 4, 2026

Study Start

September 28, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 4, 2026

Record last verified: 2026-08