Use of a Social Assistance Robot in a Population of Children Subjected to Prolonged Isolation

Social Isolation Clinical Trial

— BUDDY-GUARD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405620
• Other study ID #: RC31/23/0168
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Toulouse
• Contact: Nadege ALGANS
• Phone: 0561777204
• Email: algans.n[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: January 1, 2026
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Social Isolation

Intervention

Other:
• Assistance robot
the child controls the robot at his parent's home from his room

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the use of a social assistance robot with children hospitalized in the hemato-oncology department and subjected to prolonged isolation	number of activations of the robot and duration of the activations	1 month
Secondary	Psychological impact of the use of a social assistance robot on the child, his parents and his siblings	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
Secondary	Psychological effect of the use of a social assistance robot on the practice of nursing professionals in the service	The effects will be explored through semi-structured interviews of nursing professionnals.	Visit 2 between Day 21 and Day 45