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

Primary Purpose

Child Behavior Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Inner Garden
Sponsored by
Groupe Hospitalier de la Rochelle Ré Aunis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Child Behavior Disorders

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept 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).

Sites / Locations

  • Groupe Hospitalier de la Rochelle Ré Aunis

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Inner Garden

Arm Description

Wards without the "Inner Garden" biofeedback tool

Wards with the "Inner Garden" biofeedback tool

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Score at the Emotion Regulation Checklist
This questionnaire measures the perception of adults close to children about their ability to regulate their emotions in everyday life. It proposes 24 behavioural statements that refer to emotional responses and reactions of joy, anger, empathy with peers and adults, frustration, and activity transitions. For each statement, the adult rates the frequency of the behaviour on a 4-point Likert scale: "never", "sometimes", "often", "almost always".
Score at the Emotion Regulation Checklist
This questionnaire measures the perception of adults close to children about their ability to regulate their emotions in everyday life. It proposes 24 behavioural statements that refer to emotional responses and reactions of joy, anger, empathy with peers and adults, frustration, and activity transitions. For each statement, the adult rates the frequency of the behaviour on a 4-point Likert scale: "never", "sometimes", "often", "almost always".
Number of adverse events related to aggression/violence during group care sessions
Assault or violence against health professional with a statement in the dedicated application

Full Information

First Posted
October 26, 2020
Last Updated
September 2, 2021
Sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Collaborators
Ullo World
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1. Study Identification

Unique Protocol Identification Number
NCT04610281
Brief Title
The Inner Garden and Care for Children With Moderate to Severe Agitation
Acronym
ESSAIMS
Official Title
Pilot Study on the Care for Children With Moderate to Severe Agitation, With or Without the Use of a Semi-supervised Support Solution
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
July 6, 2021 (Actual)
Study Completion Date
July 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Collaborators
Ullo World

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior Disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Wards without the "Inner Garden" biofeedback tool
Arm Title
Inner Garden
Arm Type
Experimental
Arm Description
Wards with the "Inner Garden" biofeedback tool
Intervention Type
Device
Intervention Name(s)
Inner Garden
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Number of crises
Description
Agitation crises of moderate to severe intensity, which did not allow the child to reintegrate the group of care during the sessions
Time Frame
8 months after inclusion
Secondary Outcome Measure Information:
Title
Score at the Emotion Regulation Checklist
Description
This questionnaire measures the perception of adults close to children about their ability to regulate their emotions in everyday life. It proposes 24 behavioural statements that refer to emotional responses and reactions of joy, anger, empathy with peers and adults, frustration, and activity transitions. For each statement, the adult rates the frequency of the behaviour on a 4-point Likert scale: "never", "sometimes", "often", "almost always".
Time Frame
4 months after inclusion
Title
Score at the Emotion Regulation Checklist
Description
This questionnaire measures the perception of adults close to children about their ability to regulate their emotions in everyday life. It proposes 24 behavioural statements that refer to emotional responses and reactions of joy, anger, empathy with peers and adults, frustration, and activity transitions. For each statement, the adult rates the frequency of the behaviour on a 4-point Likert scale: "never", "sometimes", "often", "almost always".
Time Frame
8 months after inclusion
Title
Number of adverse events related to aggression/violence during group care sessions
Description
Assault or violence against health professional with a statement in the dedicated application
Time Frame
9 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nordine Benmabrouk, RN
Organizational Affiliation
Groupe Hospitalier de la Rochelle Ré Aunis
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Brigitte Laurent, PhD
Organizational Affiliation
Ullo World
Official's Role
Study Director
Facility Information:
Facility Name
Groupe Hospitalier de la Rochelle Ré Aunis
City
La Rochelle
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available with publication. Keyword are Child Behavior, Psychomotor Agitation, Psychiatric Nursing, Child Day Care Center, Tool Use Behavior, Emotional Regulation. The available version will be the locked database. The database will be made available by the study director upon request up to 15 years after publication. Medical Subject Headings (MESH) terms will be used to describe clinical data. Methodology for will be provided in the publication. International standard unit will be used.
IPD Sharing Time Frame
Data will be made available with publication (expected at the end of 2021 or beginning of 2022) and up to 15 years after the end of the study.
IPD Sharing Access Criteria
The database will be made available by the study director upon request
Citations:
PubMed Identifier
32549935
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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PubMed Identifier
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Citation
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PubMed Identifier
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Results Reference
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Results Reference
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The Inner Garden and Care for Children With Moderate to Severe Agitation

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