UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058004 |
|---|---|
| Receipt number | R000066306 |
| Scientific Title | An Investigation into the Effectiveness of Two-screen Projection Distraction in Reducing Stress in Pediatric Patients with Activity Restrictions |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/11/27 09:02:34 |
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Basic information
Public title
An Investigation into the Effectiveness of Two-screen Projection Distraction in Reducing Stress in Pediatric Patients with Activity Restrictions
Acronym
A Study on Two-Screen Projection to Reduce Stress in Pediatric Patients with Activity Restrictions
Scientific Title
An Investigation into the Effectiveness of Two-screen Projection Distraction in Reducing Stress in Pediatric Patients with Activity Restrictions
Scientific Title:Acronym
A Study on Two-Screen Projection to Reduce Stress in Pediatric Patients with Activity Restrictions
Region
| Japan |
Condition
Condition
Pediatric patients with activity restrictions
Classification by specialty
| Nursing | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the effectiveness of distraction using two-screen projection to reduce stress in pediatric patients with activity restrictions. Based on a novel method that utilizes both wall and ceiling screens for projection, the study explores the development of an environment suitable for children experiencing limited physical activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in salivary alpha-amylase activity and KOKORO scale scores before and after viewing the two-screen projection.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants perform either a mental arithmetic or maze task, followed by simultaneous saliva collection and KOKORO scale assessment. Participants watch the two-screen projection for 10 minutes, followed by simultaneous saliva collection and KOKORO scale assessment.
Interventions/Control_2
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
| 3 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patients with activity restrictions
Key exclusion criteria
Those who could not agree to the purpose and methods of this research. Those who reported feeling unwell on the day of the study. Those who are expected to suffer from motion sickness.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ogihara |
Organization
Asahikawa Medical University
Division name
Nursing Course, School of Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, JAPAN
TEL
0166-68-2936
h-ogihara@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ogihara |
Organization
Asahikawa Medical University
Division name
Nursing Course, School of Medicine
Zip code
078-8510
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, JAPAN
TEL
0166-68-2936
Homepage URL
h-ogihara@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Hokkaido, JAPAN
Tel
0166-68-2297
rs-kp.g@asahikawa-med.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 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 05 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066306
