UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058156 |
|---|---|
| Receipt number | R000066474 |
| Scientific Title | Effectiveness of group occupational therapy using Minecraft |
| Date of disclosure of the study information | 2025/06/12 |
| Last modified on | 2025/06/12 10:57:28 |
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Basic information
Public title
Effectiveness of group occupational therapy using Minecraft
Acronym
Effectiveness of group occupational therapy using Minecraft
Scientific Title
Effectiveness of group occupational therapy using Minecraft
Scientific Title:Acronym
Effectiveness of group occupational therapy using Minecraft
Region
| Japan |
Condition
Condition
Neurodevelopmental disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a Minecraft-based group occupational therapy program on social adjustment, anxiety, and sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Comparison of the two groups of differences in the mean of KIDSCREEN 27
2) Comparison of the individual values of KIDSCREEN 27 before and after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Group occupational therapy using Minecraft
Interventions/Control_2
No intervention
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with neurodevelopmental disorders
2. Patients who are between 12 and 19 years old during the period of study
3. Patients who are able to visit the Department of Children's Mental Health Care, Shinshu University Hospital.
4. Patients who can give written consent to participate in this study after receiving a full explanation of the study. Patients aged 12 years to before completion of junior high school will be asked to give written consent by a proxy and written assent by the patient himself/herself. For patients after completion of junior high school and under 19 years of age, written consent will be obtained from the patient and his/her surrogate.
Key exclusion criteria
1. Patients diagnosed with intellectual developmental disorder
2. Those who have participated in group occupational therapy using Minecraft before
3. Those who do not have a parent or guardian living with them
4. Those who are unable to wear a wearable device
5. Any other person whom the child's physician deems inappropriate as a subject
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Shiraishi |
Organization
Shinshu University
Division name
Department of Psychiatry, School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture
TEL
0263372638
kshiraishi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Shiraishi |
Organization
Shinshu University
Division name
Department of Psychiatry, School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture
TEL
0263372638
Homepage URL
kshiraishi@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Daimei Sasayama
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and
Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Biological and Medical Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture
Tel
0263-37-2572
mdrinri@shinshu-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.shinshu-u.ac.jp/tradefair/research-seeds/category/c04/post-25.html
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
20
Results
No significant differences were observed between the two groups in either the primary outcome measure (KIDSCREEN) or the OSA. A comparison between Pre-treatment and Post-treatment revealed significant improvements in Physical Well-being and Total scores of the KIDSCREEN (primary outcome measure), as well as a significant increase in sleep duration as measured by the OSA.
Results date posted
| 2025 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty junior high and high school students (6 female and 14 male participants; mean age 14.5 years, standard deviation (SD) 1.8, range 12-18 years) diagnosed with neurodevelopmental disorders.
Participant flow
Nine participants were assigned to the intervention group and eleven to the control group. No participants withdrew after consent was given.
Adverse events
No adverse events were reported.
Outcome measures
No significant differences were observed between the two groups in either the primary outcome measure (KIDSCREEN) or the OSA. No significant differences were observed in any of the categories between Baseline and Pre-treatment or between Pre-treatment and Follow-up. However, a comparison between Pre-treatment and Post-treatment revealed significant improvements in Physical Well-being and Total scores of the KIDSCREEN (primary outcome measure), as well as a significant increase in sleep duration as measured by the OSA.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066474
