An interventional study of Mindfulness-based Life Management Social Robots in Pediatric Cancer and Psychology, Child, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Supportive care
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.
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]
[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
[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
Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
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)
Device: Mindfulness-based Life Management Social Robots
Mindfulness-based life management contents for pediatric patients operated by Social Robots
Evaluation Scale of Child Emotional and Behavioral Disorders
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.
Time frame: 14 days
Measurement of Mindfulness Scale for Children and Adolescents
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.
Time frame: 14 days
Measurement of optimism in children and adolescents
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.
Time frame: 14 days
Measurement of Measurement User Experience Questionnaire Short Version (UEQs)
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).
Time frame: 14 days
In-depth interview
Interviews with study subjects based on the overall contents of the study
Time frame: 14 days
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center