NCT04610281 - The Inner Garden and Care for Children With Moderate to Severe Agitation | Crick

Overview

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.

Psychiatric illnesses affect more than one person in five each year. In France, the majority of disorders among minors under the care of child psychiatry in full or part-time hospitalization are disorders of psychological development (32%) and behavioural and emotional disorders (24.6%). Hospitalisation is reserved for the most complex acute crisis situations, as well as for children who need to be cared for by a multidisciplinary team several times a week to support their psychological development. In our study, the investigators focus on one of the clinical manifestations regularly present: the state of agitation when its intensity is moderate to severe. "The state of agitation is defined as a psychic, motor and relational behavioural disorder that leads to a reaction of intolerance on the part of people in the entourage". The care teams will then implement care actions that will be a graduated response adapted to the intensity of these states of agitation. In addition to the support provided by a caregiver, the investigators propose to use the "Inner Garden" system developed in 2014 at the laboratory of National Institute for Research in Digital Science and Technology in Bordeaux. It is an interactive Zen garden allowing to present feedback (topographical, physiological) under different sensory modalities.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

63

Conditions

Child Behavior Disorders

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.)

Eligibility

Sex: ALLMin age: 3 YearsMax age: 12 Years

Medical Language ↔ Plain English

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).

Locations (1)

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

Outcomes

Primary Outcomes

Number of Crises

Agitation crises of moderate to severe intensity, which did not allow the child to reintegrate the group of care during the sessions A mild state of agitation does not require the child to be removed from the group and from the common place of care; A moderate agitation requires removal of the child from the group but not from the common place of care; In case of serious agitation, the child must be removed from the group and from the common care area to a "calming" room where the caregiver will take care of him/her individually.

Time frame: 8 months after inclusion

Secondary Outcomes

Score at the Emotion Regulation Checklist

The ERC items assess affective stability, intensity, valence, flexibility, and situational appropriateness of children between the ages of 6 to 12 years. Items are rated by a parent on a 4-point scale (1=never, 2=sometimes, 3=often, 4=almost always) and are weighted both negatively and positively. The ERC is comprised of two scales: emotion regulation (10 items) and emotional lability/negativity (14 items). The former scale assesses expression of emotions, empathy, and emotional self-awareness, with higher scores indicating greater adaptive regulatory processes (range 10-40). The latter scale assesses lack of flexibility, anger dysregulation, and mood lability, with higher scores indicating greater emotion dysregulation (range 14-56). The Composite emotional regulation score is the sum of the emotion regulation score and the inverted emotional lability score with higher scores indicating greater adaptive regulatory processes (range 24-96).

Time frame: 4 months after inclusion

Score at the Emotion Regulation Checklist

The ERC items assess affective stability, intensity, valence, flexibility, and situational appropriateness of children between the ages of 6 to 12 years. Items are rated by a parent on a 4-point scale (1=never, 2=sometimes, 3=often, 4=almost always) and are weighted both negatively and positively. The ERC is comprised of two scales: emotion regulation (10 items) and emotional lability/negativity (14 items). The former scale assesses expression of emotions, empathy, and emotional self-awareness, with higher scores indicating greater adaptive regulatory processes (range 10-40). The latter scale assesses lack of flexibility, anger dysregulation, and mood lability, with higher scores indicating greater emotion dysregulation (range 14-56). The Composite emotional regulation score is the sum of the emotion regulation score and the inverted emotional lability score with higher scores indicating greater adaptive regulatory processes (range 24-96).