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临床试验/NCT06763042
NCT06763042已完成不适用

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

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Evaluation Scale of Child Emotional and Behavioral Disorders

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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)

干预措施: Mindfulness-based Life Management Social Robots (Device)

结局指标

主要结局

Evaluation Scale of Child Emotional and Behavioral Disorders

时间窗: 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.

Measurement of Mindfulness Scale for Children and Adolescents

时间窗: 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.

Measurement of optimism in children and adolescents

时间窗: 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.

次要结局

  • Measurement of Measurement User Experience Questionnaire Short Version (UEQs)(14 days)
  • In-depth interview(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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