UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056250 |
|---|---|
| Receipt number | R000063450 |
| Scientific Title | The Effect of Playing Video Games in the High Care Unit on the Reduction of Post-Spinal Surgery Pain |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/11/25 08:06:32 |
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Basic information
Public title
The Effect of Playing Video Games in the High Care Unit on the Reduction of Post-Spinal Surgery Pain
Acronym
The Effect of Playing Video Games in the High Care Unit on the Reduction of Post-Spinal Surgery Pain
Scientific Title
The Effect of Playing Video Games in the High Care Unit on the Reduction of Post-Spinal Surgery Pain
Scientific Title:Acronym
The Effect of Playing Video Games in the High Care Unit on the Reduction of Post-Spinal Surgery Pain
Region
| Japan |
Condition
Condition
Spinal Deseases
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate whether playing video games in the high-care unit contributes to pain relief in adult patients after spinal surgery and whether it interferes with care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average VAS score immediately after entering the GHCU and the morning after, and maximum VAS score from the time of entering the GHCU to the morning after
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Playing video games
Interventions/Control_2
Provide regular care
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are extubated after spinal surgery and admitted to the hospital's intensive care center (GHCU)
Key exclusion criteria
(1) Significant history of central nervous system disease (stroke, head injury, central nervous system infection, brain tumor, after brain surgery, after cardiopulmonary resuscitation, etc.), (2) history of psychiatric disease or dementia, (3) alcohol or other addicts, (4) patients with delirium at the time of obtaining consent, (5) patients who have never played video games , (6) patients suspected of having internet gaming disorder (screened using the NineItem Internet Gaming Disorder ScaleShort Form: IGDS9SF), (7) patients with visual impairment or dexterity problems that make it difficult to play games, (8) patients who the principal investigator deems unsuitable as research subjects for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Sato |
Organization
St. Marianna University School of Medicine
Division name
Department of Anesthesiology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
TEL
044-977-8111
nobuo.sato@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuo |
| Middle name | |
| Last name | Sato |
Organization
St. Marianna Univesrity School of Medicine
Division name
Department of Anesthesiology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
TEL
044-977-8111
Homepage URL
nobuo.sato@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Trials Committee, St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa Prefecture
Tel
044-977-8111
k-sienbu.mail@marianna-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 | 01 | Month | 01 | 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
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 23 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063450
