- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07936539
Effects of a Digital Game-Based Educational Intervention on Midwifery Students' Perceptions of Respectful Maternity Care and Empathy
Evaluation of the Effect of a Digital Game-Based Instructional Design Developed for Respectful Maternity Care on Students' Perceptions of Respectful Maternity Care and Empathy Skills
This study aims to evaluate the effects of a digital game-based educational intervention developed to teach respectful maternity care on midwifery students' perceptions of respectful maternity care and empathy skills.
The study is designed as an interventional study involving fourth-year midwifery students. Participants will be assigned to an intervention group or a control group according to the study protocol. Students in the intervention group will receive digital game-based education focusing on respectful maternity care, including effective communication, informed decision-making, privacy, dignity, and supportive care during childbirth. Students in the control group will not receive the digital game-based intervention during the study period.
Participants' perceptions of respectful maternity care and empathy skills will be assessed before and after the intervention using the measurement instruments specified in the study protocol.
The findings are expected to provide evidence regarding the potential contribution of digital game-based education to respectful maternity care training in midwifery education.
Study Overview
Status
Conditions
Detailed Description
This study employs a mixed-methods design and consists of three phases.
Phase 1 - Digital Game Development
A web-based digital educational game focusing on respectful maternity care will be developed based on the World Health Organization recommendations on intrapartum care for a positive childbirth experience, the International Confederation of Midwives' principles of respectful care, the White Ribbon Alliance Respectful Maternity Care Charter, and relevant FIGO guidelines.
The game will consist of four levels covering admission, labor, birth, and postpartum care. Each level will include scenario-based clinical situations, decision-making options, and immediate feedback. Content validity will be evaluated through expert review, and the game will be finalized following pilot testing.
Phase 2 - Randomized Controlled Trial
Fourth-year midwifery students enrolled at Cukurova University Faculty of Health Sciences will be randomly allocated to an intervention group (n=49) or a control group (n=49). Simple randomization will be performed using randomizer.org by an independent statistician.
The sample size was calculated using G\*Power software, assuming an effect size of 0.5, a significance level of 0.05, and a statistical power of 80%, with an additional 10% allowance for potential data loss.
The intervention group will receive digital game-based education on respectful maternity care. The control group will receive traditional face-to-face education delivered through a PowerPoint presentation covering the same educational content. Following completion of the posttest assessments, students in the control group will also be offered access to the digital game-based education.
Outcome measures will be assessed before and immediately after the educational intervention.
Phase 3 - Qualitative Interviews
Qualitative interviews will be conducted with students from the intervention group to explore their experiences and perceptions of digital game-based learning.
Statistical Analysis
Quantitative data will be analyzed using SPSS version 22.0. The Shapiro-Wilk test will be used to assess normality. Depending on the distribution of the data, independent-samples and paired-samples t-tests or their nonparametric alternatives (Mann-Whitney U and Wilcoxon signed-rank tests) will be applied. Statistical significance will be set at p < 0.05.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Songul Kekil, MSc
- Phone Number: +90 544 548 24 60
- Email: kekilsongul@gmail.com
Study Contact Backup
- Name: Sule Gokyildiz Surucu, Phd
- Phone Number: 1161 +90 (322) 338 64 84
- Email: gokyildizsule@gmail.com
Study Locations
-
-
Adana
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Adana, Adana, Turkey (Türkiye), 01330
- Cukurova University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Volunteering to participate in the study
- Being a fourth-year midwifery student
- Having passed the Birth Knowledge IV course
Exclusion Criteria:
- Being a first-, second- or third-year midwifery student
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Digital Game-Based Education
Fourth-year midwifery students will receive education on respectful childbirth care through a web-based digital game consisting of four levels (admission, labor, birth and postpartum care) with scenario-based clinical situations, decision-making options and immediate feedback. |
A web-based digital educational game on respectful childbirth care consisting of four levels (admission, labor, birth and postpartum care). Each level includes scenario-based clinical situations in which students choose the most appropriate approach and receive immediate feedback. |
|
Active Comparator: Traditional Education
Fourth-year midwifery students will receive face-to-face education on respectful childbirth care using a PowerPoint presentation covering the same content as the digital game. After the posttest, students in this group will also be offered the digital game-based education. |
Face-to-face lecture on respectful childbirth care delivered with a PowerPoint presentation, covering the same content as the digital game. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Students' Perceptions of Respectful Maternity Care (SP-RMC) Scale Score
Time Frame: Baseline (before the education) and immediately after the education
|
Measured with the Students' Perceptions of Respectful Maternity Care (SP-RMC) Scale developed by Dhakal et al.; Turkish validity and reliability study by Camlibel and Uludag (2023). The scale consists of 18 items and three subscales (respectful care, safety and comfort, supportive care) rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree); items 1-10 are reverse-scored. Total scores range from 18 to 90; higher scores indicate more positive perceptions of respectful maternity care. |
Baseline (before the education) and immediately after the education
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jefferson Scale of Empathy (JSE)
Time Frame: Baseline (before the education) and immediately after the education
|
Measured with the Jefferson Scale of Empathy (JSE) developed by Hojat (2002); Turkish version: "Jefferson Empati Olcegi" (Yanik and Saygili, 2013). The scale consists of 20 items and three subscales (perspective taking, compassionate care, standing in the patient's shoes) rated on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). Total scores range from 20 to 140; higher scores indicate a higher level of empathy. |
Baseline (before the education) and immediately after the education
|
|
Respectful Childbirth Care Knowledge Form Score
Time Frame: Baseline (before the education) and immediately after the education
|
Measured with the Respectful Childbirth Care Knowledge Form ("Saygili Dogum Bakimina Iliskin Bilgi Formu") developed by the researchers based on WHO, ICM, White Ribbon Alliance and FIGO guidelines. The form consists of 41 statements answered as "Yes/No"; correct answers are scored 1 and incorrect or blank answers 0. Total scores range from 0 to 41; higher scores indicate a higher level of knowledge. Content validity will be assessed by at least five academic experts in women's health and childbirth. |
Baseline (before the education) and immediately after the education
|
|
Gameful Experience Scale (GAMEX) Score
Time Frame: Immediately after the education
|
Measured with the Gameful Experience Scale (GAMEX) developed by Eppmann et al. (2018); Turkish version: "Oyun Deneyimi Olcegi" (Donmez et al.). The scale consists of 27 items and six subscales (enjoyment, absorption, creative thinking, activation, absence of negative affect, dominance) rated on a 5-point Likert scale; items of the absence of negative affect subscale are reverse-scored. Total scores range from 27 to 135; higher scores indicate a better gameful experience. Applied only to the intervention group. |
Immediately after the education
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sule Gokyildiz Surucu, PhD, Cukurova University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 05.06.2026/167-47
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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