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

Using Social Robots to Improve the Relationship and Alleviate Anxiety and Stress in Children With Rare Diseases and Their Parents: A Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Rare Diseases
• Intervention / Treatment: Behavioral: social robot intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 100226
    • National Taiwan University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retention rate	The retention rate is the average percentage of the patient-parent dyads who complete the 4-course intervention.	immediately after the intervention
acceptability	The unified theory of acceptance and use of technology (UTAUT) scale will measure participants' acceptability of the social robot intervention. The chosen domains of this scale are perceived sociability (4 items), social presence (5 items), and perceived enjoyment (5 items) due to the importance of social robot interaction and sociability. Each item is assessed on a 5-point Likert scale, varying from 1 to 5; each domain's score is summed up individually; higher scores represent more agreement with this domain.	immediately after the intervention
parent-child relationship	The elementary school student parent-child relationship scale will measure the patient's perceived parent-child relationship. The scale is composed of a 25-item questionnaire. Each item is assessed on a 5-point Likert scale, varying from 1 to 5, with total points ranging from 25 to 125, with higher scores representing better parent-child relationships. As for the parent's perceived parent-child relationship, the researcher modified part of the elementary school student parent-child relationship scale, and a psychological specialist validated the content. The score calculation is similar to the elementary school student parent-child relationship scale.	immediately after the intervention
anxiety	The Chinese Version of the State Anxiety Scale for Children will measure the patient's anxiety. The scale is composed of a 20-item questionnaire. Each item is assessed on a 3-point Likert scale, varying from 1 to 3, with total points ranging from 20 to 60, with higher scores representing higher anxiety. The State-Trait Anxiety Inventory-State Anxiety will measure the parent's anxiety. The scale is composed of a 20-item questionnaire. Each item is assessed on a 4-point Likert scale, varying from 1 to 4, with total points ranging from 20 to 80, with higher scores representing higher anxiety.	immediately after the intervention
stress	The heart rate variability and the Perceived Stress Scale will measure the patient's and the parent's stress. The researcher uses " Taiwan Scientific" Non-invasive Blood Pressure Meter to measure the heart rate variability, recording the low frequency power (LF), high frequency power (HF), and the ratio LF (ms2)/HF (ms2). The Perceived Stress Scale is composed of a 10-item questionnaire. Each item is assessed on a 5-point Likert scale, varying from 0 to 4, with total points ranging from 0 to 40, with higher scores representing higher perceived stress.	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
child-parent-robot interaction	A self-designed questionnaire and an interview framework are used to explore the child-parent-robot interaction and the effectiveness of the social robot intervention in the patients and the parents individually. The 6-item questionnaire is assessed on a Visual Analogue Scale, ranging from 0 to 10. A higher score for each item represents being more engaged in the interaction with PARO, enjoying this intervention more, or being more willing to talk about the study with each other at home. The interview framework has six open-ended questions to delve into the patient's and the parent's experiences of the intervention.	immediately after the intervention

Collaborators and Investigators

• Sponsor: National Yang Ming Chiao Tung University

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Actual): August 27, 2025
• Study Completion (Actual): August 27, 2025

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Anxiety; Robotics; Stress, Psychological; Rare Diseases; Parent-Child Relations
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Anxiety Disorders; Rare Diseases; Stress, Psychological
• Other Study ID Numbers: 2024-05-005B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No