UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000051784
Receipt number R000058839
Scientific Title Psychosocial Effects of Sony's Entertainment Robot "aibo" Intervention in Pediatric Care: As a New Intervention in Pediatric Consultation and Liaison Activities
Date of disclosure of the study information 2023/08/01
Last modified on 2023/08/01 20:03:22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The psychosocial effects of aibo on long-term hospitalized patients and their caregivers.

Acronym

Effects of aibo intervention on patients and caregivers

Scientific Title

Psychosocial Effects of Sony's Entertainment Robot "aibo" Intervention in Pediatric Care: As a New Intervention in Pediatric Consultation and Liaison Activities

Scientific Title:Acronym

aibo intervention in pediatric liaison medicine

Region

Japan


Condition

Condition

no limited

Classification by specialty

Pediatrics Child

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aibo developed at SONY will be introduced as a liaison medical treatment for children with chronic diseases requiring long-term hospitalization and for children and their families staying in medical short-term residential facilities, and its effectiveness will be examined qualitatively and quantitatively using biopsychosocial methods.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Questionnaire on aibo (parents' version, children's version, and hospital staff version)
Evaluation of the use of aibo by hospitalized and outpatient children, their parents, and staff through play using aibo

Key secondary outcomes

Behavioral Analysis
(1) Developmental screening: Denver II Developmental Determination Method
2) Qualitative analysis of interpersonal communication in play sessions
(iii) Qualitative analysis of the relationship between developmental age and interpersonal communication skills with Ivo


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

1) Children, guardians, and staff staying at the "Momiji no Ie" medical short-term care facility
2) Children, guardians, and ward staff who are hospitalized in the wards of the center (East and West wards on the 7th-10th floors of the center and Momiji no Ie)
(3) Children, guardians, and ward staff who receive outpatient care at the center
(4) Children hospitalized at Juntendo University Hospital, their guardians and ward staff

In (1) and (2), the Aibo will be introduced into the regular play activities that are currently being conducted as a pilot study.
(iii) will be a play-based intervention using Aibo in the plaza on the first floor of the outpatient wing of the center.
(iv) Introduce Aibo to the Children's Medical Center of the hospital, and conduct staff surveys and questionnaires to children and their parents.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Children and their guardians who are hospitalized at the National Center for Child Health and Development (NCCHD) or staying at Momiji no Ie, children and their guardians who are attending our center as outpatients, or children and their guardians who are hospitalized within Juntendo University Hospital Pediatric Medical Center, all of whom have had the opportunity to play with aibo.

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

400


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

Email

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


Email

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

Email

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


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

Open public recruiting

Date of protocol fixation

2020 Year 03 Month 27 Day

Date of IRB

2020 Year 03 Month 27 Day

Anticipated trial start date

2022 Year 04 Month 01 Day

Last follow-up date

2026 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 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058839


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name