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

NCT ID: NCT06999421

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gestational Diabetes Mellitus (GDM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm parallel group design: one experimental (robot-assisted) and one control (tablet-based video)
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participant

Study Groups

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Robot-Assisted Education Group

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Tablet-Based Education Group (Control)

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.

Group Type EXPERIMENTAL

Standard tablet (video playback only).

Intervention Type 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.

Interventions

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

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.

Intervention Type DEVICE

Standard tablet (video playback only).

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nursing Department

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 40510888 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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https://orcid.org/0000-0002-3146-2270

https://orcid.org/0000-0002-3146-2270

Other Identifiers

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N202309040

Identifier Type: REGISTRY

Identifier Source: secondary_id

N202309040

Identifier Type: -

Identifier Source: org_study_id