Effect of Mosaic Art on Episiotomy Repair Skills, Anxiety, and Learning Attitudes in Midwifery Students (MOSAIC-EPI)

August 31, 2026 updated by: Mine Gokduman Keles, Kahramanmaras Sutcu Imam University

The Effect of Mosaic Art Practice on Fine Motor Skills, Anxiety Levels, and Learning Attitudes in Episiotomy Repair Among Midwifery Students: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mosaic Art Group
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 Practice
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.
Behavioral: Standard Episiotomy Repair Training
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.
Active Comparator: Control Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Episiotomy Self-Efficacy
Time Frame: Immediately before and immediately after the episiotomy repair training
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
Time Frame: Baseline and immediately post-intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
State Anxiety (STAI Form TX-I)
Time Frame: Baseline and immediately post-intervention
State anxiety will be assessed using the State-Trait Anxiety Inventory, State Anxiety Form (STAI Form TX-I). The scale consists of 20 items rated on a 4-point scale. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety.
Baseline and immediately post-intervention
Attitudes Toward Learning
Time Frame: Baseline and immediately post-intervention
Attitudes toward learning will be assessed using the Attitudes Toward Learning Scale developed by Kara (2010). The scale consists of 40 items and four subdimensions: Nature of Learning (7 items), Anxiety About Learning (13 items), Expectations About Learning (9 items), and Openness to Learning (11 items). Items are rated on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree). Eleven negatively worded items are reverse scored. Higher scores indicate more positive attitudes toward learning.
Baseline and immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KSÜ-MOSAIC-EPI-2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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