NCT06405620

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

April 29, 2024

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Psychological impact of the use of a social assistance robot on the child, his parents and his siblings

    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

    Visit 2 between Day 21 and Day 45

Study Arms (1)

Robot intervention

EXPERIMENTAL

the child uses the assistance robot

Other: Assistance robot

Interventions

the child controls the robot at his parent's home from his room

Robot intervention

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Rémi IZOULET

    Toulouse Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 8, 2024

Study Start

June 1, 2024

Primary Completion

July 1, 2024

Study Completion

January 1, 2026

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share