Using Social Robots in Children With Rare Diseases and Their Parents: A Feasibility Study
NCT Number: NCT06466109
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Rare Diseases
Interventions: BEHAVIORAL: social robot intervention
Sponsor: National Yang Ming Chiao Tung University
Sex: ALL
Age: CHILD, ADULT
Enrollment: 21
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-12
Completion Date: 2025-06-15
Locations: Taipei Veterans General Hospital, Taipei, 11217, Taiwan

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.

Primary Outcome Measures: 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: 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