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

NCT ID: NCT06466109

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-12
• Study Completion Date: 2025-12-31

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 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.

Conditions

Rare Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

intervention group

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.

Group Type: EXPERIMENTAL

social robot intervention

Intervention Type: BEHAVIORAL

In the first and second courses, the patients and their parents freely interact with the social robot PARO for 30 minutes.

In the third course, patients and their parents interact with PARO for 30 minutes using a worksheet that includes naming and recording characteristics of PARO.

In the last course, patients and their parents interact with PARO for 30 minutes using a worksheet that freely recorded their observations about PARO and say goodbye to it.

Interventions

social robot intervention

In the first and second courses, the patients and their parents freely interact with the social robot PARO for 30 minutes.

In the third course, patients and their parents interact with PARO for 30 minutes using a worksheet that includes naming and recording characteristics of PARO.

In the last course, patients and their parents interact with PARO for 30 minutes using a worksheet that freely recorded their observations about PARO and say goodbye to it.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Children's Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chi-Wen Chen, PhD

Role: CONTACT

chiwenchen@ym.edu.tw

02-28267348

Facility Contacts

Tsai-Jung Wu, PhD student

Role: primary

wtj.ns13@nycu.edu.tw

+886989685387

Tsai-Jung Wu, MS

Role: primary

wtj.ns13@nycu.edu.tw

0989685387 ext. 65355

Other Identifiers

2024-05-005B

Identifier Type: -

Identifier Source: org_study_id