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Effect of Gamified Neonatal Initial Care Education on Midwifery Students

2026年10月31日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

68

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

他の名前:
  • 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.

アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Neonatal Initial Care Clinical Skills Score
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Neonatal Initial Care Knowledge Score
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年12月1日

一次修了 (推定)

2027年3月1日

研究の完了 (推定)

2027年7月1日

試験登録日

最初に提出

2026年10月27日

QC基準を満たした最初の提出物

2026年10月27日

最初の投稿 (実際)

2026年11月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年10月31日

最終確認日

2026年10月1日

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