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

Rare Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466109
• Other study ID #: 2024-05-005B
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: June 15, 2025

Study information

• Verified date: May 2024
• Source: National Yang Ming Chiao Tung University
• Contact: Chi-Wen Chen, PhD
• Phone: 02-28267348
• Email: chiwenchen[@]ym.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: June 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rare Diseases

Intervention

Behavioral:
• social robot intervention
In the first course, the patient and their parents interact with the social robot PARO for 30 minutes. In the second course, the parent interacts with PARO individually for 10 minutes, then the parent and patient interact with PARO together for 10 minutes. At last, the patient interacts with PARO for 10 minutes. In the third course, the parent interacts with PARO individually for 10 minutes, then the parent and patient interact with PARO together for 10 minutes. At last, the patient interacts with PARO for 10 minutes. In the last course, the parent interacts with PARO individually for 10 minutes, and then the patient interacts with it. At last, they interact with PARO together for 10 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming Chiao Tung University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retention rate	The retention rate is the average percentage of the patient-parent dyads who complete the 4-course intervention.	immediately after the intervention
Primary	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
Primary	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
Primary	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
Primary	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	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