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

G

Groupe Hospitalier de la Rochelle Ré Aunis

Status

Completed

Conditions

Child Behavior Disorders

Treatments

Device: Inner Garden

Study type

Interventional

Funder types

Other

Identifiers

NCT04610281
2019/P08/360

Details and patient eligibility

About

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.

Full description

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.

Enrollment

63 patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 2 patient groups

Control
No Intervention group
Description:
Wards without the "Inner Garden" biofeedback tool
Inner Garden
Experimental group
Description:
Wards with the "Inner Garden" biofeedback tool
Treatment:
Device: Inner Garden

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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