Pilot Study on the Care for Children With Moderate to Severe Agitation, With or Without the Use of a Semi-supervised Support Solution
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Number of Crises
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Control
Wards without the "Inner Garden" biofeedback tool
Inner Garden
Wards with the "Inner Garden" biofeedback tool
Intervention: Inner Garden (Device)
Outcomes
Primary Outcomes
Number of Crises
Time Frame: 8 months after inclusion
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.
Secondary Outcomes
- Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported(9 months after inclusion)
- Score at the Emotion Regulation Checklist(8 months after inclusion)
- Score at the Emotion Regulation Checklist(4 months after inclusion)