UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063452 |
|---|---|
| Receipt number | R000072629 |
| Scientific Title | Effectiveness of a Serious Game-Based E-Learning Program for Ventilator Weaning Assessment Among Nurses: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/11/10 |
| Last modified on | 2026/10/29 11:41:48 |
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Basic information
Public title
Effects of a Serious Game on Learning Ventilator Weaning Assessment Among Nurses: A Randomized Controlled Trial
Acronym
RESPI-RCT
Scientific Title
Effectiveness of a Serious Game-Based E-Learning Program for Ventilator Weaning Assessment Among Nurses: A Randomized Controlled Trial
Scientific Title:Acronym
RESPI-RCT
Region
| Japan |
Condition
Condition
Nursing education for ventilator weaning assessment
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the learning effectiveness of a serious game-based e-learning program designed to teach ventilator weaning assessment to nurses with clinical experience in mechanical ventilation management, compared with a conventional e-learning program, through a randomized controlled trial. Clinical judgment using a test case and perceptions and behaviors related to ventilator weaning assessment will be assessed at baseline and two weeks after the learning materials are provided, and changes will be compared between groups. Learners' attention, relevance to clinical practice, confidence, satisfaction, and willingness to use the learning materials in the future will also be compared between groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in clinical judgment regarding ventilator weaning assessment using a test case from baseline to two weeks after provision of the learning materials. The same test case will be administered at both time points to assess nurses' judgments of the patient's condition regarding ventilator weaning and their identification of clinical information supporting those judgments. Changes from baseline will be compared between the two groups.
Key secondary outcomes
1.Perceptions and behaviors related to ventilator weaning assessment: Items based on the Theoretical Domains Framework (TDF) will be assessed at baseline and two weeks after provision of the learning materials. Changes will be compared between groups. 2.Learning motivation: Attention, Relevance, Confidence, and Satisfaction, based on the ARCS model, will be assessed two weeks after provision of the learning materials and compared between groups.3.Willingness to use the learning materials in the future: Assessed two weeks after provision of the learning materials and compared between groups.4.Participants' feedback on the learning materials: Open-ended responses will be collected two weeks after provision of the learning materials and categorized according to similarities in content.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Serious game group
Participants in the intervention group will receive education on ventilator weaning assessment using a serious game-based e-learning program. The program uses scenarios simulating clinical situations to facilitate learning about patient assessment, integration of clinical information, clinical judgment, and the rationale for decision-making. Participants will access the program using their own internet-connected devices. The learning objectives and core educational content will be equivalent to those of the control group. A textbook on ventilator weaning assessment written by the researcher will be provided to both groups as supplementary learning material. Post-intervention assessment will be conducted two weeks after provision of the learning materials.
Interventions/Control_2
Conventional e-learning group
Participants in the control group will receive education on ventilator weaning assessment using a conventional e-learning program without game-based features. The learning objectives and core educational content will be equivalent to those of the serious game group. Participants will access the program using their own internet-connected devices. A textbook on ventilator weaning assessment written by the researcher will be provided to both groups as supplementary learning material. Post-intervention assessment will be conducted two weeks after provision of the learning materials.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria:
1. Nurses with clinical experience in the management of patients receiving mechanical ventilation.
2. Ability to complete the e-learning program and respond to questionnaires in Japanese.
3. Ability to access and complete the e-learning program using an internet-connected device.
Key exclusion criteria
Participants meeting either of the following criteria will be excluded:
1. Individuals who do not provide informed consent to participate in the study.
2. Individuals deemed ineligible by the principal investigator for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Rika |
| Middle name | |
| Last name | Kimura |
Organization
St. Luke's International University
Division name
College of Nursing
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
03-3543-6391
rikakimura@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Rika |
| Middle name | |
| Last name | Kimura |
Organization
St.Luke's International University
Division name
College of Nursing
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
03-3543-6391
Homepage URL
rikakimura@slcn.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Rika Kimura
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Luke's International University
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
Tel
03-3543-6391
rikakimura@slcn.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
聖路加国際大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
No plan to share individual participant data.
IPD sharing Plan description
Individual participant data collected in this study will not be shared with external researchers.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 29 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072629
