- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07804108
Effect of Mosaic Art on Episiotomy Repair Skills, Anxiety, and Learning Attitudes in Midwifery Students (MOSAIC-EPI)
31. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Typ studie
Intervenční
Zápis (Odhadovaný)
106
Fáze
- Nelze použít
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
|
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.
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.
|
|
Aktivní komparátor: 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
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Episiotomy Self-Efficacy
Časové okno: 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
|
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Episiotomy Repair Skill Performance
Časové okno: 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
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Baseline and immediately post-intervention
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
State Anxiety (STAI Form TX-I)
Časové okno: 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
|
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Attitudes Toward Learning
Časové okno: 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
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
28. září 2026
Primární dokončení (Odhadovaný)
30. prosince 2026
Dokončení studie (Odhadovaný)
30. prosince 2026
Termíny zápisu do studia
První předloženo
27. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
31. srpna 2026
První zveřejněno (Aktuální)
4. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
4. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
31. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- KSÜ-MOSAIC-EPI-2026
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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