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NCT Number: NCT06763042

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

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.

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Key information

Conditions

Pediatric Cancer Neoplasms Psychology, Child

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Centre

Seoul, 06351, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based Life Management Social Robots

Device

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

Primary outcomes

  1. Evaluation Scale of Child Emotional and Behavioral Disorders

    Time frame: 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.

  2. Measurement of Mindfulness Scale for Children and Adolescents

    Time frame: 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.

  3. Measurement of optimism in children and adolescents

    Time frame: 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 outcomes

  1. Measurement of Measurement User Experience Questionnaire Short Version (UEQs)

    Time frame: 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).

  2. In-depth interview

    Time frame: 14 days

    Interviews with study subjects based on the overall contents of the study

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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