Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466109
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-24
Brief Title:
Using Social Robots in Children With Rare Diseases and Their Parents A Feasibility Study
Sponsor:
National Yang Ming Chiao Tung University
Organization:
National Yang Ming Chiao Tung University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 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 Friedmans 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None