UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051781 |
|---|---|
| Receipt number | R000058928 |
| Scientific Title | Distraction healing effect by aibo during immunization |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/08/01 19:49:21 |
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Basic information
Public title
Healing effect of aibo to alleviate anxiety and prevent trauma before and after immunization.
Acronym
Anxiety-reducing effects of aibo
Scientific Title
Distraction healing effect by aibo during immunization
Scientific Title:Acronym
Distraction using aibo
Region
| Japan |
Condition
Condition
no limitation
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of whether aibo intervention can be an alternative to the distraction role
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain assessment using visual analog scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group:vaccination with aibo present
Interventions/Control_2
Control group: vaccination with a stuffed dog
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Clinic visits for vaccinations
Key exclusion criteria
Those with underlying diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Tanaka |
Organization
National Center for Child Health and Development
Division name
Division of Mental Health Care, Department of Child and Adolescent Liaison
Zip code
1578535
Address
2-10-1, Okura, Setagaya-ku, Tokyo
TEL
0334160181
tanaka-kyo@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Tanaka |
Organization
National Center for Child Health and Development
Division name
Division of Mental Health Care, Department of Child and Adolescent Liaison
Zip code
1578535
Address
2-10-1, Okura, Setagaya-ku, Tokyo
TEL
0334160181
Homepage URL
tanaka-kyo@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Cabinet Office
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
National Center for Child Health and Development
Address
2-10-1, Okura, Setagaya-ku, Tokyo
Tel
0334160181
tanaka-kyo@ncchd.go.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
| 2023 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://capmh.biomedcentral.com/articles/10.1186/s13034-022-00519-1
Publication of results
Published
Result
URL related to results and publications
https://capmh.biomedcentral.com/articles/10.1186/s13034-022-00519-1
Number of participants that the trial has enrolled
57
Results
There were 57 participants in the study. The intervention group consisted of 32 participants and the control group consisted of 25 participants. Results of a comparison between the two groups on each measure showed that on the face scale, the intervention group was significantly lower than the control group after vaccination . Also, on the psychologist's behavioral observation scale, the intervention group was significantly lower than the control group after 5 minutes of vaccination.
Results date posted
| 2023 | Year | 07 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
There were 57 participants in the study, with participant ages ranging from 3 to 12 years. The intervention group consisted of 32 participants with a mean age of 4.41 years (3-12 years, median 3 years) and the control group consisted of 25 participants with a mean age of 3.96 years (3-9 years, median 3 years).
Participant flow
Children and their parents who visited the hospital in even-number months were assigned to the control group, while children and their parents who visited in odd-numbered months were assigned to the intervention group. Intervention and observation conducted pre and post vaccination.
no one was excluded, no one was lost to follow-up and no one was discontinued intervention.
Adverse events
There were no adverse events associated with the intervention.
Outcome measures
Results of a comparison between the two groups on each measure showed that on the face scale, the intervention group was significantly lower than the control group after vaccination (t(55) =2.582, p =0.0125, d=0.69). Also, on the psychologist's behavioral observation scale, the intervention group was significantly lower than the control group after 5 minutes of vaccination (t(55) =2.772, p = .00759, d=0.74).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058928
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