Clinical trial NCT06466109: Using Social Robots in Children With Rare Diseases and Their Parents: A Feasibility Study
Official title: Using Social Robots to Improve the Relationship and Alleviate Anxiety and Stress in Children With Rare Diseases and Their Parents: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rare Diseases
Keywords: Robotics
Parent-Child Relations
Anxiety
Stress, Psychological
Rare Diseases
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 21
Sex: ALL
Minimum age (years): 8
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-group, pretest-posttest clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goals of this clinical trial are to (a) evaluate the feasibility and acceptability of a social robot intervention for providing family-based care for rare diseases families and (b) explore the effectiveness of the social robot intervention in improving the parent-child relationships and alleviating stress and anxiety for rare diseases patients and their parents. The main questions are:

* Is the social robot intervention suitable for and acceptable to rare disease patients and parents?
* Does the social robot intervention improve the parent-child relationship of rare disease patients and their parents?
* Does the social robot intervention alleviate the stress and anxiety of rare disease patients and their parents? Patients and their parents will interact with the social robot PARO separately and together in each 30-minute course every two weeks for four courses.

Detailed description: Children with rare disease and their caregivers are distressed and stressed to deal with the disease and daily life, and their parent-child relationships are also challenging. Although social robots have been used to improve patients' and caregivers' well-being in clinical settings, there still needs to be family-centered, child-friendly, convenient, and feasible interventions for patients with rare diseases and their families. This study aims to evaluate the feasibility and acceptability of a social robot intervention for providing family-based care for rare disease families and explore the effectiveness of the social robot intervention in improving the parent-child relationships and alleviating stress and anxiety for rare disease patients and their parents. A single-group, pretest-posttest feasibility study will be conducted in a medical center in Northern Taiwan. Of 21 dyads of 8- to 19-year-old children with rare diseases and their parents will be enrolled. The dyads will interact with the social robot PARO in each 30-minute course every two weeks for four courses. The retention rate will be calculated after the study, and the Friedman's test and Wilcoxon signed rank test will analyze the changes in the parent-child relationship, the anxiety, the perceived stress scales, and the heart rate variability. The content analysis will be used to analyze the interview data to delve into the child-parent-robot interaction and the effectiveness of the social robot intervention in the patients and the parents. This study is expected to provide a feasible and effective intervention to improve the psychological and social health of children with rare diseases and their caregivers and provide a reference for future randomized controlled trials of social robots in pediatric care.

Eligibility criteria: Inclusion Criteria:

\[Patients\]

* Aged 8 to 19 years.
* Diagnosed with a rare disease.
* Be Able to communicate in Chinese. \[Parents\]
* A father or a mother of a child with a rare disease.
* Be Able to communicate in Chinese.

Exclusion Criteria:

\[Patients\]

* Have a pacemaker.
* Have open wounds.
* Being infected with infectious diseases.
* Be unable to participate in social activities due to severe psychological disorder or cognitive dysfunction.

\[Parents\]

* Have a pacemaker.
* Have open wounds.
* Being infected with infectious diseases.
* Be unable to participate in social activities due to severe psychological disorder or cognitive dysfunction.

Primary outcomes:
measure: retention rate
timeFrame: immediately after the intervention
measure: acceptability
timeFrame: immediately after the intervention
measure: parent-child relationship
timeFrame: immediately after the intervention
measure: anxiety
timeFrame: immediately after the intervention
measure: stress
timeFrame: immediately after the intervention
Secondary outcomes:
measure: child-parent-robot interaction
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: