An interventional study of Gamified Hybrid Escape Room-Based Neonatal Initial Care Education and Conventional Theoretical Neonatal Initial Care Education in Midwifery Education and Neonatal Care Education, sponsored by KTO Karatay University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by KTO Karatay University · Not applicable, Interventional, and Other
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.
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.
KTO Karatay University is the lead sponsor of 128 studies on the registry; 16 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Gamified Hybrid Escape Room-Based Neonatal Initial Care Education · Behavioral: Conventional Theoretical 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.
Behavioral: Conventional Theoretical Neonatal Initial Care Education
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.
Also known as: 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.
Change in Neonatal Initial Care Clinical Skills Score
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.
Time frame: Baseline (T0) and within 2 weeks after the intervention (T1)
Change in Neonatal Initial Care Knowledge Score
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.
Time frame: Baseline (T0), within 2 weeks post-intervention (T1), 1 month (T2), and 3 months (T3) post-intervention
Change in General Self-Efficacy Score
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.
Time frame: Baseline (T0), within 2 weeks post-intervention (T1), 1 month (T2), and 3 months (T3) post-intervention
Plan to share: No
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