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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06763042
Enrollment
50
Registered
2025-01-08
Start date
2023-09-20
Completion date
2024-01-31
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cancer, Psychology, Child

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

Interventions

DEVICEMindfulness-based Life Management Social Robots

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

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Clinical trials with a single arm

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation Scale of Child Emotional and Behavioral Disorders14 daysMeasure 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 Adolescents14 daysMeasure 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 adolescents14 daysMeasure 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

MeasureTime frameDescription
Measurement of Measurement User Experience Questionnaire Short Version (UEQs)14 daysMeasurement 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 interview14 daysInterviews with study subjects based on the overall contents of the study

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026