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

Not Applicable

Completed

• Conditions: Pediatric Cancer; Psychology, Child

• Registration Number: NCT06763042
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-30
• Study Start: 2023-09-20
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation Scale of Child Emotional and Behavioral Disorders	14 days	Measure and compare the score of Korea-Child Behavior Checklist (K-CBCL) before and after intervention. Change in psychological adaptation scores among pediatric and adolescent patients as measured by a validated psychological adaptation questionnaire. The questionnaire includes subscales for emotional regulation, coping mechanisms, and social engagement. Results will be reported as mean changes in scores from baseline to 14 days.
Measurement of Mindfulness Scale for Children and Adolescents	14 days	Measure and compare the score of Korean Child and Adolescent Mindfulness Measure (K-CAMM) before and after intervention. Change in psychological adaptation scores among pediatric and adolescent patients as measured by a validated psychological adaptation questionnaire. The questionnaire includes subscales for emotional regulation, coping mechanisms, and social engagement. Results will be reported as mean changes in scores from baseline to 14 days.
Measurement of optimism in children and adolescents	14 days	Measure and compare the score of The Children's Life Orientation Test (CLOT) before and after intervention. Change in psychological adaptation scores among pediatric and adolescent patients as measured by a validated psychological adaptation questionnaire. The questionnaire includes subscales for emotional regulation, coping mechanisms, and social engagement. Results will be reported as mean changes in scores from baseline to 14 days.

Secondary Outcome Measures

Name	Time	Method
Measurement of Measurement User Experience Questionnaire Short Version (UEQs)	14 days	Measurement of Measurement User Experience Questionnaire Short Version (UEQs) after intervention. Number of reported difficulties in interacting with the social robot, as assessed by a semi-structured usability survey. The survey includes items on ease of interaction, clarity of instructions, and overall user satisfaction. Responses will be quantified on a Likert scale (1 = very difficult, 5 = very easy).
In-depth interview	14 days	Interviews with study subjects based on the overall contents of the study

Trial Locations

Locations (1)

Samsung Medical Centre; 🇰🇷 Seoul, Korea, Republic of