UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051783 |
|---|---|
| Receipt number | R000058985 |
| Scientific Title | Psychological effects of group intervention therapy with aibo for long-term hospitalized patients |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/08/02 08:59:31 |
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Basic information
Public title
Psychosocial benefits of aibo for a small group of long-term hospitalized children
Acronym
group therapy with aibo
Scientific Title
Psychological effects of group intervention therapy with aibo for long-term hospitalized patients
Scientific Title:Acronym
group intervention therapy with aibo
Region
| Japan |
Condition
Condition
no limitation
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Group intervention therapy using aibo, a robot developed by SONY, will be conducted to examine the healing effects on children and their families qualitatively and quantitatively using biopsychosocial methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Biological indicators
Stress-related substances: serotonin, noradrenaline, cortisol, chromogranin A, etc.
Immunity: secreted immunoglobulin (s-IgA), cytokines such as interleukin, TNF, etc.
Autonomic nervous system: HVA, MHPG, blood pressure, pulse rate change (R-R interval)
Emotional function: blood dynamics of neurotransmitters such as serotonin, noradrenaline, and dopamine, and neuropeptides such as BDNF and vasopressin
Attachment: oxytocin
Key secondary outcomes
(2) Psychological Indicators
Child Anxiety (STAI)
Pain in children (VAS)
Depression in children (Japanese version of DSRS-C)
Children's quality of life (QOL): Infant version of the QOL scale (for children and parents), Elementary and middle school QOL scale (for children and parents)
Children's behavior assessment (Children's Behavior Questionnaire: CBCL)
Social indicators
Family relationships (FDT: Family Diagnostic test)
Family QOL (WHO SUBI: The Subjective Well-being Inventory: a measure of mental health based on 11 sub-items recommended by WHO)
Length of hospital stay, presence of complications, etc.
(4)
Interpersonal Interaction Style Analysis Items
Interpersonal Interaction Style Analysis Items
Joint attention with others
Prosocial Behavior
Aggressive behavior
Sharing one's feelings (non-verbal)
Self-emotional sharing (verbal)
Questioning/help-seeking behavior
Situation awareness and sharing
Recognizing and sharing others' behaviors and situations
Imitation of actions and sounds
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group: Group intervention therapy using Aibo (30 minutes) x 6 times (twice a week)
Interventions/Control_2
Control group: Group therapy using regular play (30 min) x 6 times (twice a week)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Children with physical illness (pediatric cancer, transplant surgery) who have been hospitalized for more than one month at our center and their families
2) Children hospitalized for more than 1 month in our department (mainly adjustment disorder, depression, etc.)
Key exclusion criteria
Patients who are 18 years of age or older at the time consent is obtained, or who are otherwise judged by the principal investigator to be unsuitable as subjects.
Target sample size
30
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
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
Results
Results of Behavior Analysis (Interim Report)
No difference in age between intervention and non-intervention groups
No differences by age between intervention and non-intervention groups.
Joint gazing with others and prosocial behaviors were more common in the intervention group
More in the intervention group than in the non-intervention group in sharing one's feelings (verbal) and questioning/need for help behavior
Results date posted
| 2023 | Year | 08 | Month | 01 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Analysis in progress Comparison between the two groups is in progress.
Date of the first journal publication of results
| 2021 | Year | 10 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2020 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2021 | 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
| 2023 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058985
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
