UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049577 |
|---|---|
| Receipt number | R000056464 |
| Scientific Title | Investigation of stress reduction effect by subjective evaluation of two-screen image projection |
| Date of disclosure of the study information | 2022/11/25 |
| Last modified on | 2023/07/31 19:25:37 |
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Basic information
Public title
Investigation of stress reduction effect by subjective evaluation of two-screen image projection
Acronym
Subjective evaluation of two-sided image projection
Scientific Title
Investigation of stress reduction effect by subjective evaluation of two-screen image projection
Scientific Title:Acronym
Subjective evaluation of two-sided image projection
Region
| Japan |
Condition
Condition
Child in medical care
Classification by specialty
| Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the stress reduction effect of two-sided video projection on the wall and the floor by obtaining the subjective evaluation of three persons: children with medical care, their parents, and professional staff who interact with children with medical care on a daily basis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The independent variable is a two-sided video projection that serves as a visual stimulus, and the dependent variable is a subjective evaluation using the KOKORO scale, which is common to medical care children, parents, and professional staff.
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
Before viewing the 2-sided video projection, the subject completes the KOKORO scale in 1 minute and views the 2-sided video projection. After that, the participants again fill in the KOKORO scale in one minute.
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Medically cared children under 18 years of age and their parents or guardians, who are professional staff
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
30
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Oku |
Organization
Gunma University
Division name
Faculty of Informatics
Zip code
376-8515
Address
1-5-1 Tenjin-cho, Kiryu-shi, Gunma
TEL
0277-30-1940
h.oku@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Oku |
Organization
Gunma University
Division name
Faculty of Informatics
Zip code
376-8515
Address
1-5-1 Tenjin-cho, Kiryu-shi, Gunma
TEL
0277-30-1940
Homepage URL
h.oku@gunma-u.ac.jp
Sponsor or person
Institute
Gunma 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
Ethical Guidelines for Medical and Health Research Involving Human Subjects
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
| 2022 | Year | 11 | Month | 25 | 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
24
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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | 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
| 2022 | Year | 11 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056464
