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Effect of Gamified Neonatal Initial Care Education on Midwifery Students

31. Oktober 2026 aktualisiert von: Hediye Karakoç, KTO Karatay University

Development and Evaluation of a Gamified Neonatal Initial Care Intervention: A Randomized Controlled Trial of Knowledge, Clinical Skills, and Self-Efficacy Among Midwifery Students

This randomized controlled trial aims to evaluate the effectiveness of a gamified neonatal initial care educational intervention on knowledge, clinical skills, and self-efficacy among undergraduate midwifery students.

Neonatal initial care requires appropriate clinical knowledge, practical skills, and timely decision-making. Gamification-based educational approaches may support active learning and provide opportunities to practice clinical decision-making in simulated environments.

The study is planned to include 68 undergraduate midwifery students at KTO Karatay University in Türkiye. Participants will be randomly assigned to an intervention group (n=34) or a control group (n=34).

Both groups will receive theoretical education on neonatal initial care. The intervention group will additionally participate in a hybrid escape room activity combining a web-based digital game with hands-on simulation using neonatal mannequins and clinical equipment. The control group will continue with conventional theoretical education without the additional gamified activity.

The primary outcome will be neonatal initial care clinical skills, assessed through an Objective Structured Clinical Examination (OSCE) before and shortly after the intervention. Secondary outcomes will include neonatal initial care knowledge and general self-efficacy, assessed at baseline, shortly after the intervention, and at one-month and three-month follow-up.

The study will examine whether adding a gamified hybrid escape room activity to conventional theoretical education improves learning outcomes among midwifery students.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study is designed as a prospective, two-arm, parallel-group randomized controlled trial to evaluate the effectiveness of gamified neonatal initial care education on knowledge, clinical skills, and self-efficacy among undergraduate midwifery students.

The study will be conducted at KTO Karatay University, Türkiye. A total of 68 undergraduate midwifery students who meet the eligibility criteria and provide informed consent will be enrolled. Participants will be allocated to the intervention group (n=34) or the control group (n=34) using a 1:1 allocation ratio.

Stratified randomization will be performed according to academic semester (fifth, sixth, seventh, or eighth) and type of high school completed (health vocational high school or other). Eight strata will be established, and random assignment within each stratum will be conducted using a computerized random-number generator by an independent researcher.

Both groups will receive theoretical education on neonatal initial care.

The intervention group will additionally participate in a gamified hybrid escape room activity integrating digital learning with physical simulation. The educational intervention will be developed using the D6 gamification framework and delivered through the ActionBound web-based platform and a clinical skills laboratory.

The activity will include clinical scenarios and tasks related to equipment selection, thermal protection, APGAR assessment, airway suctioning decisions, physical examination and identification, immunization, eye and umbilical cord care, and initiation of mother-infant contact and breastfeeding.

Students in the intervention group will participate in teams of three. They will complete interactive digital tasks and perform corresponding practical procedures using neonatal mannequins and clinical equipment. Gamification elements will include points, levels, immediate feedback, badges, and leaderboards. The escape room activity will last no longer than 30 minutes.

The control group will receive conventional theoretical education on neonatal initial care and continue their regular educational activities without the additional gamified intervention.

The primary outcome will be neonatal initial care clinical skills, assessed using an Objective Structured Clinical Examination (OSCE). Clinical skills will be evaluated at baseline (T0) and during the short-term post-intervention assessment (T1). The structured OSCE assessment will include a procedural checklist, clinical interpretation criteria, and a global performance rating. The total score will range from 0 to 41, with higher scores indicating better performance.

Secondary outcomes will include neonatal initial care knowledge and general self-efficacy. Knowledge will be assessed using a researcher-developed multiple-choice questionnaire. General self-efficacy will be evaluated using the 23-item General Self-Efficacy Scale, with total scores ranging from 23 to 115.

Knowledge and self-efficacy will be assessed at four time points: baseline (T0), short-term post-intervention (T1), one-month follow-up (T2), and three-month follow-up (T3). Clinical skills will be assessed only at T0 and T1 to minimize potential learning effects associated with repeated practical examinations.

Statistical analyses will compare changes in outcomes between the intervention and control groups. Group-by-time effects will be examined using statistical models appropriate to the number of repeated measurements for each outcome. An intention-to-treat approach will be used, and results will be reported with effect estimates and 95% confidence intervals.

The study aims to determine whether a hybrid gamified educational intervention provides additional benefits compared with conventional theoretical education in undergraduate midwifery training.

Studientyp

Interventionell

Einschreibung (Geschätzt)

68

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Being an undergraduate student enrolled in a midwifery program in the fifth semester or higher.
  • Having no courses that need to be repeated.
  • Voluntarily agreeing to participate in the study and providing informed consent.

Exclusion Criteria:

  • Currently working or having previously worked in a neonatal unit or delivery room.
  • Having attendance-related absences from the educational activities required for the study.
  • Holding a certificate related to neonatal initial care practices.
  • Not having sufficient Turkish language proficiency in reading, listening, writing, speaking, or comprehension.
  • Having a hearing or visual impairment.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Gamified Neonatal Initial Care Education

Participants allocated to the intervention group will receive theoretical education on neonatal initial care followed by a gamified hybrid escape room activity integrating web-based digital learning and hands-on simulation. Students will participate in teams of three and complete interactive clinical scenarios and practical tasks using neonatal mannequins and clinical equipment. The activity will include points, badges, immediate feedback, and leaderboards and will last no longer than 30 minutes.

A gamified neonatal initial care educational intervention delivered through a hybrid escape room combining a web-based digital platform (ActionBound) with physical simulation in a clinical skills laboratory. The activity consists of sequential clinical tasks addressing equipment preparation, thermal protection, APGAR assessment, airway suctioning decisions, physical examination and identification, immunization, eye and umbilical cord care, and initiation of mother-infant contact and breastfeeding.

Students will work in teams of three and perform practical procedures using neonatal mannequins and clinical equipment. Gamification elements include points, badges, levels, immediate feedback, and leaderboards. The activity will be supervised by researchers and completed within a maximum of 30 minutes.

Andere Namen:
  • Gamified Neonatal Initial Care Education

Conventional theoretical education covering essential neonatal initial care practices, including preparation for newborn care, thermal protection, assessment of neonatal adaptation, airway and respiratory assessment, physical examination, routine neonatal care, and initiation of breastfeeding. The same theoretical education will be provided to participants in both the intervention and control groups.

Aktiver Komparator: Conventional Neonatal Initial Care Education

Participants allocated to the control group will receive conventional theoretical education on neonatal initial care. They will continue their regular educational activities without participating in the additional gamified hybrid escape room intervention.

Conventional theoretical education covering essential neonatal initial care practices, including preparation for newborn care, thermal protection, assessment of neonatal adaptation, airway and respiratory assessment, physical examination, routine neonatal care, and initiation of breastfeeding. The same theoretical education will be provided to participants in both the intervention and control groups.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Neonatal Initial Care Clinical Skills Score
Zeitfenster: Baseline (T0) and within 2 weeks after the intervention (T1)

Change in neonatal initial care clinical skills will be assessed using an Objective Structured Clinical Examination (OSCE) conducted in a simulated clinical environment. The assessment includes a procedural performance checklist (0-28 points), clinical interpretation criteria (0-8 points), and a global performance rating (1-5 points). The total score ranges from 1 to 41, with higher scores indicating better clinical performance. The primary outcome will be the change in total OSCE score from baseline to the short-term post-intervention assessment. The difference in score changes between the intervention and control groups will be evaluated.

Baseline (T0) and within 2 weeks after the intervention (T1)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Neonatal Initial Care Knowledge Score
Zeitfenster: Baseline (T0), within 2 weeks post-intervention (T1), 1 month (T2), and 3 months (T3) post-intervention

Neonatal initial care knowledge will be assessed using a researcher-developed multiple-choice questionnaire covering essential neonatal initial care practices. Each question has one correct answer. Correct responses will receive 1 point, while incorrect responses will receive 0 points, with no penalty for incorrect answers. The total score will be calculated as the sum of correct responses, with higher scores indicating greater knowledge. A score of at least 70% of the maximum possible score will be considered satisfactory. Changes in knowledge scores from baseline to post-intervention and follow-up assessments will be compared between the intervention and control groups.

Baseline (T0), within 2 weeks post-intervention (T1), 1 month (T2), and 3 months (T3) post-intervention
Change in General Self-Efficacy Score
Zeitfenster: Baseline (T0), within 2 weeks post-intervention (T1), 1 month (T2), and 3 months (T3) post-intervention

General self-efficacy will be assessed using the 23-item General Self-Efficacy Scale developed by Sherer and colleagues and adapted into Turkish by Gözüm and Aksayan. Each item is rated on a 5-point Likert scale. Negatively worded items are reverse-scored according to the scale instructions. Total scores range from 23 to 115, with higher scores indicating greater perceived general self-efficacy. Changes in total scores from baseline to post-intervention and follow-up assessments will be compared between the intervention and control groups.

Baseline (T0), within 2 weeks post-intervention (T1), 1 month (T2), and 3 months (T3) post-intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mitarbeiter

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Dezember 2026

Primärer Abschluss (Geschätzt)

1. März 2027

Studienabschluss (Geschätzt)

1. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

27. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Oktober 2026

Zuerst gepostet (Tatsächlich)

2. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • AY-NEONATAL-2026-001

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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