Effect of Gamified Neonatal Initial Care Education on Midwifery Students

October 31, 2026 updated by: 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.

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.

Detailed Description

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.

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.
68

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: None (Open Label)

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: 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.
Behavioral: Gamified Hybrid Escape Room-Based 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.

Other Names:
  • Gamified Neonatal Initial Care Education
Behavioral: Conventional Theoretical 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.
Active Comparator: 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.
Behavioral: Conventional Theoretical 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.

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
Change in Neonatal Initial Care Clinical Skills Score
Time Frame: 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)

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
Change in Neonatal Initial Care Knowledge Score
Time Frame: 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
Time Frame: 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

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.
KTO Karatay University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

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.
December 1, 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.
March 1, 2027

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.
July 1, 2027

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).
October 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.
October 27, 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.
November 2, 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.
November 3, 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.
October 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.
October 1, 2026

More Information

Terms related to this study

Keywords

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.
  • AY-NEONATAL-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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