MedTrace Logo

The Inner Garden and Care for Children With Moderate to Severe Agitation

NCT04610281 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-08-09

Study results available
· View outcomes & findings →

Summary

The objective is to compare the care including the solution of ambient sensory biofeedback "Inner Garden", compared to the care without this solution, on the regulation of behavioral disorders during a crisis requiring to take the child out of group care. The nursing support with the "Inner Garden" tool in three care units will be compared with the practice in six other units not equipped with this tool.

Conditions

  • Child Behavior Disorders

Interventions

DEVICE

Inner Garden

Care actions adapted to the intensity of the states of agitation (The child can be removed from the group while remaining in the same room on a chair with a caregiver. If the problems are too serious, the child can be accompanied to a "soothing" room where the carer will take care of him/her individually. In units equipped with Inner Garden, the child can use it under semi- supervision of nurses.)

Sponsors & Collaborators

  • Ullo World

    collaborator INDUSTRY

  • Groupe Hospitalier de la Rochelle Ré Aunis

    lead OTHER

Principal Investigators

  • Nordine Benmabrouk, RN · Groupe Hospitalier de la Rochelle Ré Aunis

  • Brigitte Laurent, PhD · Ullo World

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2021-07-06
Completion
2021-07-06

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04610281 on ClinicalTrials.gov