Midwifery EducationNCT07910929
Effect of Gamified Neonatal Initial Care Education on Midwifery Students
A study testing Gamified Hybrid Escape Room-Based Neonatal Initial Care Education and Conventional Theoretical Neonatal Initial Care Education in people with Midwifery Education and Neonatal Care Education, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Midwifery Education, Neonatal Care Education
- What is being tested?
- Gamified Hybrid Escape Room-Based Neonatal Initial Care Education and Conventional Theoretical Neonatal Initial Care Education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
KTO Karatay University
Konya, Karatay, 42020
HEDİYE KARAKOÇ, PhD, 05412291726, hediye.bekmezci@karatay.edu.tr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Midwifery Education, Neonatal Care Education
- Being tested
- Gamified Hybrid Escape Room-Based Neonatal Initial Care Education, Conventional Theoretical Neonatal Initial Care Education
- Keywords
- Gamification, Neonatal Initial Care, Midwifery Students, Escape Room, Simulation-Based Education, Clinical Skills, Self-Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Hybrid Escape Room-Based Neonatal Initial Care EducationBehavioural
Also called Gamified 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.
Conventional Theoretical Neonatal Initial Care EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Gamified Neonatal Initial Care Education | Experimental | 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. Receives: Behavioral: Gamified Hybrid Escape Room-Based Neonatal Initial Care Education; Behavioral: Conventional Theoretical Neonatal Initial Care Education |
| Conventional Neonatal Initial Care Education | Active comparator | 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. Receives: Behavioral: Conventional Theoretical Neonatal Initial Care Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0) and within 2 weeks after the intervention (T1)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (T0), within 2 weeks post-intervention (T1), 1 month (T2), and 3 months (T3) post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midwifery EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Hediye Karakoç, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910929
- Sponsor's protocol ID
- AY-NEONATAL-2026-001
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Gamified Neonatal Initial Care Intervention: A Randomized Controlled Trial of Knowledge, Clinical Skills, and Self-Efficacy Among Midwifery Students
- ClinicalTrials.gov ID
- NCT07910929
- Acronym / sponsor ID
- AY-NEONATAL-2026-001
- Conditions
- Midwifery Education, Neonatal Care Education
- Keywords
- Gamification, Neonatal Initial Care, Midwifery Students, Escape Room, Simulation-Based Education, Clinical Skills, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamified Neonatal Initial Care Education | Experimental | Behavioral: Gamified Hybrid Escape Room-Based Neonatal Initial Care Education, Behavioral: Conventional Theoretical Neonatal Initial Care EducationParticipants 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. |
| Conventional Neonatal Initial Care Education | Active comparator | Behavioral: Conventional Theoretical Neonatal Initial Care EducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified Hybrid Escape Room-Based Neonatal Initial Care EducationAlso: Gamified Neonatal Initial Care EducationA 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. | Behavioural | Gamified Neonatal Initial Care Education |
| Conventional Theoretical Neonatal Initial Care EducationConventional 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. | Behavioural | Conventional Neonatal Initial Care Education, Gamified Neonatal Initial Care Education |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Midwifery Education
Not yet recruiting
Effects of EbeCast Digital Learning on Midwifery Students' Women's Health Skills
Midwifery Education, Clinical Skills Training
Not yet recruiting
Psychosocial Effects of Empathy-Based Midwifery Education on Midwifery Students and Pregnant Women
Empathy, Anxiety
Enrolling by invitation
Low-Fidelity Simulation Training for Leopold Maneuvers in Midwifery Students
Clinical Skills Training, Midwifery Education
Not yet recruiting
Roy Adaptation Model-Based Prenatal Education in Hypertensive Pregnant Women
Hypertensive Disorders of Pregnancy (HDP)
Not yet recruiting
Effect of Mosaic Art on Episiotomy Repair Skills, Anxiety, and Learning Attitudes in Midwifery Students
Education, Nursing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Hybrid Escape Room-Based Neonatal Initial Care Education and Conventional Theoretical Neonatal Initial Care Education in people with Midwifery Education and Neonatal Care Education, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HEDİYE KARAKOÇ, PhD (5412291726, hediye.bekmezci@karatay.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neonatal Initial Care Clinical Skills Score (time frame: Baseline (T0) and within 2 weeks after the intervention (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.