Clinical trial NCT06763042: Usability and Utility of Mindfulness-based Life Management Social Robots for Children and Adolescents in the Long-term Treatment
Official title: Evaluation of the Usability and Utility of Mindfulness-based Life Management Social Robots for Children and Adolescents in the Long-term Treatment Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Psychology, Child
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical trials with a single arm
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation Scale of Child Emotional and Behavioral Disorders
timeFrame: 14 days
measure: Measurement of Mindfulness Scale for Children and Adolescents
timeFrame: 14 days
measure: Measurement of optimism in children and adolescents
timeFrame: 14 days
Secondary outcomes:
measure: Measurement of Measurement User Experience Questionnaire Short Version (UEQs)
timeFrame: 14 days
measure: In-depth interview
timeFrame: 14 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre
Study officials:
affiliation: Samsung Medical Center
name: Meong Hi Son
role: PRINCIPAL_INVESTIGATOR
References: