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Completed

NCT Number: NCT04610281

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

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.

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Key information

Conditions

Child Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Inner Garden

Device

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 outcomes

  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

    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

  1. Score at the Emotion Regulation Checklist

    Time frame: 4 months after inclusion

    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).

  2. Score at the Emotion Regulation Checklist

    Time frame: 8 months after inclusion

    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).

  3. Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported

    Time frame: 9 months after inclusion

    Assault or violence against health professional with a statement in the dedicated application.

    In cases of severe agitation, the child's hetero-aggressive actions may injure the caregiver.

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Collaborators

  • Ullo World

Registry information

Official study title

Pilot Study on the Care for Children With Moderate to Severe Agitation, With or Without the Use of a Semi-supervised Support Solution

Acronym: ESSAIMS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2020
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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