NCT06999421

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 4, 2025

Last Update Submit

May 22, 2025

Conditions

Gestational Diabetes Mellitus (GDM)

Outcome Measures

Primary Outcomes (2)

  • Anxiety Level

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

    Immediately post-intervention

  • Health Literacy

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

    Immediately post-intervention

Secondary Outcomes (2)

  • Health education Satisfaction

    Immediately post-intervention

  • Technology Acceptance

    Immediately post-intervention

Study Arms (2)

Robot-Assisted Education Group

EXPERIMENTAL

Participants in this group receive a 30-minute robot-assisted digital health education session about gestational diabetes mellitus (GDM). The robot delivers content using animated videos, emotional facial expressions, gesture recognition, and interactive responses via touch and voice input.

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

Tablet-Based Education Group (Control)

EXPERIMENTAL

Participants in this group receive the same 30-minute health education content about GDM via a standard tablet. The video is identical to that in the experimental group but lacks interactive features such as gesture recognition or robot expressions.

Device: Standard tablet (video playback only).

Interventions

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

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.

Robot-Assisted Education Group
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.

Tablet-Based Education Group (Control)

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing Department

Taipei, 110, Taiwan

Location

Related Publications (1)

  • Yang CL, Xu ZY, Chang CY. The Impact of Robot-Assisted Digital Education on Prenatal Women's Health Literacy: A Randomized Controlled Trial. J Nurs Manag. 2025 Jun 5;2025:8865606. doi: 10.1155/jonm/8865606. eCollection 2025.

    PMID: 40510888DERIVED

Related Links

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two-arm parallel group design: one experimental (robot-assisted) and one control (tablet-based video)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2025

First Posted

May 31, 2025

Study Start

November 1, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)