CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Inner Gardendevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04610281
NCT04610281N/ACompleted
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Pilot Study on the Care for Children With Moderate to Severe Agitation, With or Without the Use of a Semi-supervised Support Solution

Groupe Hospitalier de la Rochelle Ré Aunis·interventional·Posted Oct 30, 2020·Updated Aug 9, 2024

In Brief

A clinical study evaluating Inner Garden for Child Behavior Disorders. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChild Behavior Disorders
CountriesFrance
CollaboratorsUllo World

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 30, 2020
Enrollment StartNov 2, 2020
Primary CompletionJul 6, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.7 years ago

Interventions

Inner Gardendevice

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.)