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CompletedNCT06999421RADEUpdated May 31, 2025

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

An interventional study of Robot with interactive animations, gesture recognition, and touch/voice-based input and Standard tablet (video playback only). in Gestational Diabetes Mellitus (GDM), sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to female participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Nov 2023, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Gestational Diabetes Mellitus (GDM)

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03

In context

Diabetes, Gestational

857 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.

This study's enrollment of 80 is below the median of 110 across 560 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 256 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Non-Taiwanese nationality
  • Chronic disease history
  • Cognitive impairment or psychiatric disorder
  • Declined participation
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    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.

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

  • Experimental
    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.

    Device: Standard tablet (video playback only).

Interventions

  • DeviceRobot 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.

  • DeviceStandard 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.

06

What researchers measure

Primary outcomes

  1. Anxiety Level

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

    Time frame: Immediately post-intervention

  2. Health Literacy

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

    Time frame: Immediately post-intervention

Secondary outcomes

  1. Health education Satisfaction

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

    Time frame: Immediately post-intervention

  2. Technology Acceptance

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

    Time frame: Immediately post-intervention

07

Study locations

1 site
  • Nursing Department
    Taipei, 110, Taiwan
08

References and documents

Publications

  • 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. PubMed 40510888 ↗

Study documents

  • Study protocol · May 4, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2023 to primary completion in Jan 2024, 2 months.

Of 303 non-industry interventional studies with no phase under Diabetes, Gestational, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 48. This study's 2 months is below that.

Counting every sponsor, half of 306 studies reached it within 28 months; a quarter within 13 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
May 4, 2025
First posted
May 31, 2025
StartActual
Nov 1, 2023
Primary completionActual
Jan 31, 2024
CompletionActual
Jan 31, 2024
Last update
May 31, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06999421
Responsible party
Sponsor
First posted
May 31, 2025
Start date
Nov 1, 2023
Primary completion
Jan 31, 2024
Completion
Jan 31, 2024
Last update
May 31, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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