Vaginal Breech Birth Management Educational Mobile Game Design and Evaluation for Midwifery Students
Phase: NA
Conditions: Vaginal Breech Delivery Management, Mobile Game
Sponsor: Eskisehir Osmangazi University

STUDY PROTOCOL WITH STATISTICAL ANALYSIS PLAN 
 
Study Title: Vaginal Breech Birth Management: serious mobile game design and evaluation 
for midwifery students 
 
 
NCT Number: NCT05551611   
Document Date: March 14, 2025 
 
 

1. Background and Rationale 
Vaginal breech birth (VBB) is now an infrequent clinical event; consequently, midwifery 
students have limited real-life learning opportunities. Serious games offer cost-effective, 
repeatable simulation experiences that can enhance knowledge acquisition. This study evaluates 
a bespoke mobile serious game designed to teach VBB management and compares it with 
traditional lecture-based instruction. 
2. Aims 
• To determine whether the serious mobile game improves short-term knowledge of VBB 
management compared with a traditional lecture. 
• To compare knowledge retention at 14 days and 7 months post-intervention between 
groups. 
3. Study Design 
Prospective, 
parallel-group, 
randomised 
controlled 
quasi-experimental 
trial 
with 
pre-test/post-test assessments. 
• 
Setting: Midwifery departments of two Turkish universities (Kocaeli University & 
Eskişehir Osmangazi University). 
• 
Duration: February 2022 – December 2022 (follow-up to July 2023). 
4. Study Population and Eligibility Criteria 
Third-year midwifery students. 
Inclusion:  
• Completed “Normal Childbirth & Postpartum” course.  
• Provide written informed consent. 
Exclusion: Previous theoretical or practical training on breech presentation. 
5. Interventions 
5.1. Experimental Arm – “Game Group” 

Students play the Vaginal Breech Birth Management Serious Mobile Game once (≈ 30–
45 min) under supervised classroom conditions. Headphones supplied; individual play; no time 
limit. 
5.2. Control Arm – “Lecture Group” 
Traditional 45-min lecture covering identical VBB content, delivered by the same investigator 
with slides & discussion. 
6. Outcome Measures 
Type 
Name 
Description 
Scale (range) Direction 
Primary 
Vaginal Breech 
Birth 
Management 
Knowledge Test 
47-item multiple-choice test 
assessing knowledge of trauma 
& management in VBB. Each 
correct answer = 1 point; Total 
score 0–47. No subscales; 
higher scores = better 
knowledge/outcome. 
0–47 scores 
on a scale 
Higher = better 
Assessments at baseline (pre-test), Day 0 (immediately after intervention), Day 14, and 
Month 7. 
7. Sample Size & Power Calculation 
Using Day 0 pilot means (Game=40.5±4.2; Control=37.8±5.1), α=0.05, two-sided Mann–
Whitney U, power=0.80 required n=35 per group. Allowing 10 % attrition, recruitment target 
set at 40 per group (total 80). Final analysed: Game=39; Control=40. 
8. Randomisation and Allocation 
Simple randomisation (1:1) using computer-generated list by independent statistician. Group 
assignment placed in sealed opaque envelopes; opened by researcher immediately before 
session. 
9. Data Collection Procedures 

Knowledge test administered on paper. Unique codes used instead of names. Data entered twice 
into SPSS 20.0; discrepancies resolved by audit. 
10. Statistical Analysis Plan (SAP) 
10.1. Primary Outcome Analysis 
• 
Between-group comparison (Day 0): Mann–Whitney U test. 
• 
Report Median (IQR) & Mean ± SD. 
10.2. Secondary/Exploratory Analyses 
• 
Within-group change over time: Friedman two-way repeated measures ANOVA 
(pre, Day 0, Day 14, Month 7). Post-hoc Dunn-Bonferroni pairwise tests. 
• 
Between-group at Day 14 & Month 7: Mann–Whitney U. 
10.3. Assumptions & Checking 
• 
Normality checked via Shapiro–Wilk; non-normal distribution anticipated ⇒ 
non-parametric tests chosen. 
10.4. Handling Missing Data 
Complete-case analysis. Participants with missing follow-up tests excluded from that specific 
time-point analysis; no imputation performed (anticipated < 5 % missing). 
10.5. Software 
IBM SPSS Statistics v20.0 (Armonk, NY, USA). 
10.6. Interim Analysis 
None planned; single-session educational intervention with minimal risk. 
11. Ethical Considerations 

Ethics approval: Kocaeli University Non-Interventional Clinical Research Ethics Committee 
(28 Jan 2022; GOKAEK-2022/02.11). Study conducted by Declaration of Helsinki. Written 
informed consent obtained. Data anonymised. 
12. Data Monitoring & Safety 
Minimal-risk educational study; no independent DSMB. Adverse events unlikely; any 
unanticipated problems to be reported to ethics committee within 7 days. 
13. Administrative Information & Protocol Amendments 
All substantial amendments approved by ethics committee and recorded in ClinicalTrials.gov 
history.