NCT07806747

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of serious game-based learning compared with conventional learning in improving clinical reasoning among nursing students in Vietnam. Additionally, the study will assess students' self-confidence in pediatric nursing care, intrinsic motivation, and satisfaction with the learning experience. A minimum of 104 second-year nursing students will be randomly assigned to either the intervention group (serious game-based learning) or the control group (conventional learning). Both groups will receive six teaching sessions based on the content of the Pediatric Care Nursing curriculum, conducted outside the formal curriculum, with each session lasting approximately three hours. Outcomes will be measured at multiple time points, while learning satisfaction will be assessed immediately after completion of the intervention.

Trial Health

63
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Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

September 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 1, 2026

Last Update Submit

September 22, 2026

Conditions

Keywords

clinical reasoningserious gamesnursing studentsnursing education

Outcome Measures

Primary Outcomes (2)

  • Clinical reasoning

    This study will use the Vietnamese version of the 16-item Clinical Reasoning Scale (CRS) to measure nursing students' clinical reasoning ability. Each item is rated on a five-point Likert scale. Total scores range from 16 to 80, with higher scores indicating greater clinical reasoning ability.

    Baseline, immediately after intervention, and follow up at one-month post intervention.

  • clinical reasoning

    This study will use the Clinical Reasoning Performance Rubric (CRPR) to provide an objective assessment of nursing students' clinical reasoning. The rubric consists of eight domains, each rated from 0 to 3. Total scores range from 0 to 24, with higher scores indicating better clinical reasoning.

    Baseline, immediately after intervention, and follow-up at one-month post-intervention.

Secondary Outcomes (3)

  • Confidence

    Baseline, immediately after intervention, and follow-up at one-month post-intervention.

  • motivation

    Baseline, immediately after intervention, and follow-up at one-month post-intervention.

  • Student Satisfaction

    Immediately after intervention

Study Arms (2)

Serious Games

EXPERIMENTAL

Participants assigned to this group will receive serious game-based learning based on the content of the Pediatric Care Nursing course. The intervention will be delivered over six teaching sessions conducted outside the formal curriculum, with each session lasting approximately three hours.

Behavioral: Serious game - based learning

Conventional Teaching

ACTIVE COMPARATOR

Participants assigned to this group will receive conventional learning based on the same Pediatric Care Nursing course content over six teaching sessions conducted outside the formal curriculum, with each session lasting approximately three hours.

Behavioral: Conventional teaching

Interventions

Participants in the control group will receive traditional teaching covering the same topics as the intervention group. The intervention will be delivered in one 3-hour session per week for up to 6 weeks. Each session will consist primarily of instructor-led lectures using presentation slides. Clinical scenarios will be presented by the instructor through lecture slides without small-group discussion. Question-and-answer activities will be conducted after the lecture.

Conventional Teaching

Participants in the intervention group will receive six weekly serious game-based learning sessions. Each 3-hour session will include a lecture, serious game play, group presentation, discussion, and reflection.

Serious Games

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Second-year undergraduate nursing students.
  • Students who have not previously taken the Pediatric Care Nursing course

You may not qualify if:

  • Students who do not agree to participate in the study.
  • Students who are repeating the Pediatric Care Nursing course.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bach Mai Medical college, Bach Mai hospital

Hà Nội, Vietnam

Location

Study Officials

  • Thi Kim Chi Do

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two teaching methods will be compared: serious game-based teaching as the intervention and conventional teaching as the control.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 8, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data from this study.

Locations