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

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ClinicalTrials.gov Identifier: NCT04610281
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Ullo World
Information provided by (Responsible Party):
Groupe Hospitalier de la Rochelle Ré Aunis

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.

Condition or disease Intervention/treatment Phase
Child Behavior Disorders Device: Inner Garden Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : November 2, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
No Intervention: Control
Wards without the "Inner Garden" biofeedback tool
Experimental: Inner Garden
Wards with the "Inner Garden" biofeedback tool
Device: Inner Garden
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 Measures :
  1. 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


Secondary Outcome Measures :
  1. Score at the Emotion Regulation Checklist [ Time Frame: 4 months after inclusion ]
    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".

  2. Score at the Emotion Regulation Checklist [ Time Frame: 8 months after inclusion ]
    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".

  3. Number of adverse events related to aggression/violence during group care sessions [ Time Frame: 9 months after inclusion ]
    Assault or violence against health professional with a statement in the dedicated application



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610281


Contacts
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Contact: Caroline Allix-Béguec, PhD +33516494246 caroline.allix-beguec@ght-atlantique17.fr

Locations
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France
Groupe Hospitalier de la Rochelle Ré Aunis Recruiting
La Rochelle, France
Sponsors and Collaborators
Groupe Hospitalier de la Rochelle Ré Aunis
Ullo World
Investigators
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Study Director: Nordine Benmabrouk, RN Groupe Hospitalier de la Rochelle Ré Aunis
Study Director: Brigitte Laurent, PhD Ullo World
Publications:

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Responsible Party: Groupe Hospitalier de la Rochelle Ré Aunis
ClinicalTrials.gov Identifier: NCT04610281    
Other Study ID Numbers: 2019/P08/360
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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.
Access Criteria: The database will be made available by the study director upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders
Child Behavior Disorders
Neurodevelopmental Disorders