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

NCT06763042 | Completed

• 1 other identifier: 2023-03-057-006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer; Psychology, Child

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  14 days

Secondary Outcomes (2)

• Measurement of Measurement User Experience Questionnaire Short Version (UEQs)

  14 days

• In-depth interview

  14 days

Study Arms (1)

Groups that use the Mindfulness-based Life Management Social Robots

EXPERIMENTAL

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

Interventions

Mindfulness-based Life Management Social Robots DEVICE

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

Groups that use the Mindfulness-based Life Management Social Robots

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Centre

Seoul, Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Meong Hi Son

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trials with a single arm

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: January 8, 2025
• Study Start: September 20, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: January 8, 2025

Record last verified: 2023-08

Locations

KR (1)