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

NCT06466109 | Completed

• 1 other identifier: 2024-05-005B
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Rare Diseases

Keywords

Robotics; Parent-Child Relations; Anxiety; Stress, Psychological; Rare Diseases

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• child-parent-robot interaction

  immediately after the intervention

Study Arms (1)

intervention group

EXPERIMENTAL

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

Interventions

social robot intervention 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.

intervention group

Eligibility Criteria

• Age: 8 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \[Patients\]
• 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.

You may not qualify if:

• \[Patients\]
• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (2)

National Taiwan University Children's Hospital

Taipei, 100226, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Rare Diseases; Anxiety Disorders; Stress, Psychological

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-group, pretest-posttest clinical trial

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 20, 2024
• Study Start: July 12, 2024
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: April 13, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)