UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059038 |
|---|---|
| Receipt number | R000067534 |
| Scientific Title | Effects of Distraction Intervention Using Real-Time Two-screen Projection on Stress Reduction and Social Interaction in Pediatric Patients |
| Date of disclosure of the study information | 2025/09/09 |
| Last modified on | 2025/09/09 20:53:18 |
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Basic information
Public title
Effects of Distraction Intervention Using Real-Time Two-screen Projection on Stress Reduction and Social Interaction in Pediatric Patients
Acronym
Real-Time Two-Screen Projection for Stress Reduction and Social Interaction Support in Pediatric Patients
Scientific Title
Effects of Distraction Intervention Using Real-Time Two-screen Projection on Stress Reduction and Social Interaction in Pediatric Patients
Scientific Title:Acronym
Real-Time Two-Screen Projection for Stress Reduction and Social Interaction Support in Pediatric Patients
Region
| Japan |
Condition
Condition
Pediatric patients
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to compare and evaluate the stress-reducing effects of recorded playback versus real-time two-screen projection in pediatric patients, and to examine whether real-time two-screen projection can serve as a tool to promote social interaction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The outcome measures of this study were changes in salivary alpha-amylase activity and KOKORO scale scores measured before and after viewing recorded playback and real-time two-screen projection. The outcome measures also included, based on behavioral observation, the duration of gaze at the projection screen, the frequency of verbal and nonverbal communication such as spontaneous verbal initiations and waving with a smile, the number of verbal utterances, and their content.
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
The procedure of performing a mental arithmetic or maze task, followed by simultaneous salivary collection and KOKORO scale assessment, then viewing a 5-minute recorded playback or real-time two-screen projection and repeating the salivary collection and assessment, was conducted twice. This procedure was divided into Pattern A and Pattern B depending on whether the recorded playback or the real-time projection was viewed first.
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
Key exclusion criteria
Individuals who did not provide consent for the purpose and procedures of this study.
Individuals using medications that affect the autonomic nervous system.
Individuals who reported poor health on the day of the study.
Individuals predicted to experience severe 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 | 09 | Month | 09 | 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 | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067534
