UMIN-ICDS Clinical Trial

Public title

Psychosocial benefits of aibo for long-term hospitalized children

Acronym

aibo Individual Psychotherapy

Scientific Title

Effectiveness of individualized intervention therapy with aibo in long-term hospitalized patients

Scientific Title:Acronym

individualized intervention therapy with aibo

Region

Japan

Condition

no limitation

Classification by specialty

Pediatrics

Child

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aibo, developed by SONY, will be introduced as a liaison medical treatment for children with chronic diseases requiring long-term hospitalization, and the healing effects on the children and their families will be examined qualitatively and quantitatively using biopsychosocial methods. In this study, individual intervention therapy will be examined.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Blood (serotonin, noradrenaline, cortisol, chromogranin A, secreted immunoglobulin levels (s-IgA), interleukin, TNF, HVA, MHPG measurements, oxytocin equivalent)
At session initial intervention, after 1 week of intervention, after 4 weeks of intervention, after 6 weeks of intervention, after 8 weeks of intervention, after 10 weeks of intervention, and after 12 weeks of intervention.

Key secondary outcomes

STAI, VAS, Japanese version of DSRS-C, infant version of QOL scale (for parents), elementary and middle school QOL scale (for parents), CBCL
FDT, SUBI, length of hospitalization, complications, etc.
Children: number of utterances and emotional expressions (positive and negative in two directions), etc., eye contact, voice, touching, emotional parameters of aibo, etc., by participant observation

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Individualized interactive play (20 minutes) for children using Aibo twice a week for a minimum of 4 weeks starting after obtaining consent during the hospitalization period.

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Children who have been hospitalized at the center for at least one month and whose parents were able to obtain research consent

Key exclusion criteria

Patients who are 18 years of age or older at the time consent is obtained, other patients who are deemed inappropriate as subjects by the principal investigator, and patients who are discharged from the hospital within one month of the start of the study.

Target sample size

10

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

Email

tanaka-kyo@ncchd.go.jp

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

Email

tanaka-kyo@ncchd.go.jp

Institute

National Center for Child Health and Development

Institute

Department

Personal name

Organization

Cabinet Office

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Center for Child Health and Development

Address

2-10-1, Okura, Setagaya-ku, Tokyo

Tel

0334160181

Email

tanaka-kyo@ncchd.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

08

Month

01

Day

URL releasing protocol

https://onlinelibrary.wiley.com/doi/10.1111/ped.15064

Publication of results

Partially published

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1111/ped.15064

Number of participants that the trial has enrolled

1

Results

127 hospitalized children (0-6 months to 13 years old) and 116 of their caregivers were recruited as participants.
Results showed that 2/3 of the children had positive expressions and 1/4 had negative expressions, but negative children were seen to eventually become positive. Caregivers were 2/3 active expressions such as "participate" and "explore" and 1/3 were calm expressions such as "watch over" and "encourage".

Results date posted

2023

Year

07

Month

19

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2022

Year

05

Month

04

Day

Baseline Characteristics

A total of 127 children (aged 0.6 months to 13 years) and 116 caregivers who were admitted to the medical and surgical wards of the NCCHD were recruited as participants. This number included children and caregivers who participated in multiple sessions; the number of children and caregivers who participated in a single intervention ranged from 1 to 15 (median 4.5) and from 1 to 10 (median 4.5), respectively.

Participant flow

From March 14 to April 12 2018, 24 series of GRI were conducted for 30 min at a time during 14:00 to 15:30 in the playrooms of nine medical wards of Internal Medicine and Surgery, at NCCHD. One child psychiatrist or a clinical psychologist attended as an assistant and an observer (AO). The size of the ward playroom is about 3 by 5 m. At the fixed time, the AO turned on aibo to begin the GRI. The AO saw to it to ensure that no harm would be caused upon children, caregivers, and aibo. At every session, the AO explained to children and caregivers aibo's basic movements, how to touch aibo to please him, and how to bring out songs, poses, or dances that aibo expresses. The AO observed the children and caregivers as they naturally played with aibo and recorded their words and behaviour on the behaviour observation records . At the end of 30 min, the A/O made a statement such as time for aibo to go to bed and turned off aibo, stroking and wiping it with clean cloth to finish.

Adverse events

There were no adverse events associated with the intervention.

Outcome measures

Results showed that 2/3 of the children had positive expressions and 1/4 had negative expressions, but negative children were seen to eventually become positive. Caregivers were 2/3 active expressions such as "participate" and "explore" and 1/3 were calm expressions such as "watch over" and "encourage

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

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

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related 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=R000058937