Using Social Robots in Children With Rare Diseases and Their Parents: A Feasibility Study

National Yang Ming Chiao Tung University

Status: Enrolling

Conditions: Rare Diseases

Treatments: Behavioral: social robot intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06466109

2024-05-005B

Details and patient eligibility

About

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.

Full 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 two medical centers 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 8 to 19 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: social robot intervention