Use of a Social Assistance Robot in a Population of Children Subjected to Prolonged Isolation (BUDDY-GUARD)

May 6, 2024 updated by: University Hospital, Toulouse

Mixed Observational Study Evaluating the Use of a Social Assistance Robot in a Population of Children Subjected to Prolonged Isolation

During the period of isolation of the hospitalized child, contacts between the child and his family are impaired. Being away from home as well as from the social and family circle can be harmful for the hospitalized child. It seems necessary to measure the impact of the use of such an assistance robot both on the user himself and his family. Thus, it seems relevant to scientifically validate the benefit of using such an assistance robot to break iatrogenic social isolation and to measure the impact of this use.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children hospitalized in the pediatric hemato-oncology department whose duration of isolation is estimated to be greater than two weeks.
  • Children who have accepted the robot and whose parents have accepted its use in their home.
  • Agreement of holders of parental authority for the inclusion of the hospitalized child.

Exclusion Criteria:

  • Patient or two parents who do not have a sufficient level of French for research.
  • Cognitive or motor disorders in children, not allowing the use of the robot and/or the carrying out of semi-structured interviews.
  • Cognitive disorders in parents and/or siblings that do not allow semi-structured interviews to be carried out.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot intervention
the child uses the assistance robot
Other: Assistance robot
the child controls the robot at his parent's home from his room

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the use of a social assistance robot with children hospitalized in the hemato-oncology department and subjected to prolonged isolation
Time Frame: 1 month
number of activations of the robot and duration of the activations
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological impact of the use of a social assistance robot on the child, his parents and his siblings
Time Frame: Visit 1 between Day 10 and Day 20 et visit 2 between Day 21 and Day 45
psychological effects measured by semi-directive interviews of the parents and the brothers and sisters
Visit 1 between Day 10 and Day 20 et visit 2 between Day 21 and Day 45
Psychological effect of the use of a social assistance robot on the practice of nursing professionals in the service
Time Frame: Visit 2 between Day 21 and Day 45
The effects will be explored through semi-structured interviews of nursing professionnals.
Visit 2 between Day 21 and Day 45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Rémi IZOULET, Toulouse Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • RC31/23/0168

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Social Isolation

Clinical Trials on Assistance robot

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe