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NCT Number: NCT06999421

The Impact of Robot-assisted Digital Education on Prenatal Women's Health Literacy

This randomized controlled trial evaluates the effectiveness of a robot-assisted digital education program for pregnant women diagnosed with gestational diabetes mellitus (GDM). The intervention aims to reduce anxiety, improve health literacy, and increase satisfaction and acceptance of digital health technologies. Participants are randomly assigned to either a robot-assisted education group or a conventional tablet-based video education group. Outcome measures include anxiety scores, health literacy scores, and educational satisfaction.

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

21 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nursing Department

Taipei, 110, Taiwan

About this study

This study implemented a robot-assisted digital education method for teaching about gestational diabetes mellitus (GDM) that was intended to reduce anxiety and encourage healthy behaviors among pregnant women. A randomized controlled trial was conducted to assess the effectiveness of the intervention, where 66 pregnant women from a single hospital were randomly assigned to either the experimental group (n = 32) or the control group (n = 34). The experimental group received health education about GDM using a robot, while the control group received the same health education through video presentations on a tablet. The results showed that the implemented robot-assisted digital education method not only reduced anxiety levels among pregnant women, but also influences their health education satisfaction, health literacy, and acceptance of technology. In the global information age, this study can serve as a reference for educators and researchers at medical institutions interested in tracking long-term health education through technological tools.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women aged ≥21 years
  • Diagnosed with gestational diabetes mellitus (GDM)
  • Normal first prenatal ultrasound
  • Taiwanese nationality
  • Provided informed consent

Exclusion criteria

  • Non-Taiwanese nationality
  • Chronic disease history
  • Cognitive impairment or psychiatric disorder
  • Declined participation

Treatment and study plan

Robot with interactive animations, gesture recognition, and touch/voice-based input

Device

A humanoid educational robot that provides GDM-related content using animated videos, emotional facial expressions, gesture movements, and voice/touch-based interaction. Designed to increase engagement, reduce anxiety, and improve health literacy among pregnant women.

Standard tablet (video playback only).

Device

A standard touchscreen tablet used to deliver pre-recorded educational videos on GDM. This intervention provides passive viewing without any robot interaction or feedback.

Primary outcomes

  1. Anxiety Level

    Time frame: Immediately post-intervention

    Anxiety levels were assessed using a Likert-type scale ranging from 1 (no symptoms) to 5 (severe anxiety).

  2. Health Literacy

    Time frame: Immediately post-intervention

    Health literacy, which also used a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree)

Secondary outcomes

  1. Health education Satisfaction

    Time frame: Immediately post-intervention

    Health education satisfaction was using a Likert scale ranging from 1 (very satisfied) to 5 (very dissatisfied)

  2. Technology Acceptance

    Time frame: Immediately post-intervention

    technology acceptance of the pregnant women was measured using another Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree)

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

The Impact of Robot-assisted Digital Education on Prenatal Women's Health Literacy: A Randomized Controlled Trial

Acronym: RADE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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