Usability and Utility of Mindfulness-based Life Management Social Robots for Children and Adolescents in the Long-term Treatment

NCT ID: NCT06763042

Last Updated: 2025-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2024-01-31

Brief Summary

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The purpose of this study is to apply social robot-based mindfulness-based life management content to pediatric and adolescent patients in the long-term disease treatment process and to assess usability and effectiveness of the social robot-based mindfulness-based life management content.

\[Question 1\] Effectiveness: Was the content on social robots effective in psychological adaptation of pediatric and adolescent patients?

\[Question 2\] Usability: Is there any difficulty in interacting through social robots applied in the hospital environment?

The participants conduct a preliminary survey and use robot content at least 10 times for the two weeks. Afterwards, follow-up surveys and in-depth interviews will be conducted.

Detailed Description

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The purpose of this study is to apply social robot-based mindfulness-based life management content to pediatric and adolescent patients in the long-term disease treatment process and to assess usability and effectiveness of the social robot-based mindfulness-based life management content.

\[Intervention\]

* Intervention period: 15-20 minutes or more per day for 14 days (at least 10 times in 2 weeks)
* Content: Life management content for mindfulness play and disease understanding
* Method of provision: Robot interaction using chatbot and remote conversation (mindfulness-based living management content and remote content will be provided for a total of 15 to 20 minutes)

\[Question 1\] Effectiveness: Was the content on social robots effective in psychological adaptation of pediatric and adolescent patients?

(Measure) Pre-post comparison of survey result values

* Child Emotional and Behavioral Disorder Assessment Scale (Korea-Child Behavior Checklist: K-CBCL) ② Child and Youth Mindfulness Scale (Korean Child and Adolescent Mindfulness Measure: K-CAMM) ③ Child and Youth Optimism Scale (The Children's Life Orientation Test: C-LOT)

\[Question 2\] Usability: Is there any difficulty in interacting through social robots applied in the hospital environment?

(Measure) User Experience Questionnaire(UEQ), In-depth Interview

Conditions

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Pediatric Cancer Psychology, Child

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Clinical trials with a single arm
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Groups that use the Mindfulness-based Life Management Social Robots

Intervention period: 15-20 minutes or more per day for 14 days (at least 10 times in 2 weeks)

Content: Life management content for mindfulness play and disease understanding

Method of provision: Robot interaction using chatbot and remote conversation (mindfulness-based living management content and remote content will be provided for a total of 15 to 20 minutes)

Group Type EXPERIMENTAL

Mindfulness-based Life Management Social Robots

Intervention Type DEVICE

Mindfulness-based life management contents for pediatric patients operated by Social Robots

Interventions

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Mindfulness-based Life Management Social Robots

Mindfulness-based life management contents for pediatric patients operated by Social Robots

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients aged 6 to 12 years old who is being treated after the diagnosis of a severe or chronic disease
* Pediatric patients who need hospital treatment, including inpatient or outpatient treatment, for more than 3 months
* Pediatric patients with a level of communication that can be understood and agreed to in this study

Exclusion Criteria

* Those who disagree with this study
* Pediatric patients who are judged to be difficult to interact with robots due to communication difficulties
* Pediatric patients who has been diagnosed with or is being treated for mental illness with psychotic characteristics
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meong Hi Son

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Centre

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2023-03-057-006

Identifier Type: -

Identifier Source: org_study_id

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