The Impact of Robot-assisted Digital Education on Prenatal Women's Health Literacy: A Randomized Controlled Trial
Phase: NA
Conditions: Gestational Diabetes Mellitus (GDM)
Sponsor: Taipei Medical University

Study Protocol 
Title: The Impact of Robot-assisted Digital Education on Prenatal Women’s Health Literacy 
NCT Number: NCT20230940 
Document Date: 2025-05-04 
1. Background and Rationale 
The study addresses the increasing need for efficient, standardized prenatal health 
education, especially in light of nursing workforce shortages. Robot-assisted education 
presents a novel digital solution that may reduce anxiety and enhance health literacy among 
pregnant women, particularly those diagnosed with gestational diabetes mellitus (GDM). 
2. Study Objectives 
- Primary Objective: To evaluate whether robot-assisted digital education reduces anxiety 
among pregnant women with GDM. 
- Secondary Objectives: To examine the impact on health literacy, satisfaction with health 
education, and acceptance of digital technologies. 
3. Study Design 
Type: Randomized Controlled Trial (RCT) 
Setting: Obstetrics outpatient clinic of a regional hospital in Taiwan 
Duration: November 2023 to January 2024 
Groups: 
   - Experimental group: Robot-assisted education 
   - Control group: Tablet-based video education 
Blinding: Single-blind (participant and assessor) 
4. Participants 
Inclusion Criteria: 
- Pregnant women aged ≥21 
- GDM diagnosis 
- Taiwanese nationality 
Exclusion Criteria: 
- Chronic illness 
- Cognitive impairment or language barrier 

5. Intervention 
A 30-minute robot-assisted session on GDM information using visual, audio, and interactive 
storytelling features. 
6. Outcomes 
Primary: Hamilton Anxiety Rating Scale (HAMA) 
Secondary: Health Literacy Questionnaire (HLQ), Satisfaction (adapted Black et al.), 
Technology Acceptance 
7. Ethics 
Approved by the Institutional Review Board of Taipei Medical University. Informed consent 
obtained(ethical approval number N202309040). 
8. Data Availability 
Available upon reasonable request to the corresponding author. 

Statistical Analysis Plan 
Title: Statistical Analysis Plan for the RCT “The Impact of Robot-assisted Digital Education 
on Prenatal Women’s Health Literacy” 
NCT Number: NCT20230940 
Document Date: 2025-05-04 
1. Sample Size Calculation 
Using G*Power with a medium effect size (d = 0.5), alpha = 0.05, power = 0.80. Minimum of 
64 participants required. Target recruitment: 80 (to allow for dropouts). 
2. Randomization 
Block randomization via computer-generated sequence. Allocation concealed until 
participant assignment. 
3. Analysis Methods 
Baseline Characteristics: Independent t-tests or chi-square 
Primary Outcome (Anxiety): Independent samples t-test 
Secondary Outcomes: 
   - Health literacy, satisfaction, technology acceptance: t-tests 
   - Associations: One-way ANOVA and chi-square tests 
Software Used: SPSS v25 
Missing Data: Excluded from per-protocol; ITT analysis with multiple imputation 
recommended in future studies 
4. Significance Level 
Two-tailed tests with α = 0.05.