N/A
Completed N=63
The Inner Garden and Care for Children With Moderate to Severe Agitation
Child Behavior Disorders
Source: ClinicalTrials.gov NCT04610281 ↗
Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Number of Crises — 97; 35 crises
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Crises |
97; 35 | — |
| SECONDARY Score at the Emotion Regulation Checklist |
21.6; 22.5; 32.0; 34.5; 53.6; 56.7 | — |
| SECONDARY Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported |
2; 1; 28; 32 | — |
Eligibility Criteria
Inclusion Criteria
- Taken care in Children's Hospitalization Unit of Child Psychiatry Department,
- Parent affiliated or beneficiary of social security,
- Information to the child and the legal representative(s) and signed consent by the legal representative(s).
Exclusion Criteria
- Refusal to participate on the part of the child and/or legal representative(s).
Data sourced from ClinicalTrials.gov (NCT04610281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.