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| Name | Class |
|---|---|
| Ullo World | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Wards without the "Inner Garden" biofeedback tool | |
| Inner Garden | Experimental | Wards with the "Inner Garden" biofeedback tool |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | 8 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Score at the Emotion Regulation Checklist | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nordine Benmabrouk, RN | Groupe Hospitalier de la Rochelle Ré Aunis | Study Director |
| Brigitte Laurent, PhD | Ullo World | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier de la Rochelle Ré Aunis | La Rochelle | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32549935 | Background | Domon-Archambault V, Terradas MM, Drieu D, De Fleurian A, Achim J, Poulain S, Jerrar-Oulidi J. Mentalization-Based Training Program for Child Care Workers in Residential Settings. J Child Adolesc Trauma. 2019 Jun 21;13(2):239-248. doi: 10.1007/s40653-019-00269-x. eCollection 2020 Jun. | |
| 17892148 | Background |
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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.
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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.
The database will be made available by the study director upon request
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Wards without the "Inner Garden" biofeedback tool |
| FG001 | Inner Garden | Wards with the "Inner Garden" biofeedback tool 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.) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Wards without the "Inner Garden" biofeedback tool |
| BG001 | Inner Garden | Wards with the "Inner Garden" biofeedback tool 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.) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 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. | Posted | Number | crises | 8 months after inclusion |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Wards without the "Inner Garden" biofeedback tool | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brigitte Laurent | Ullo World | +33782096875 | brigitte@ullo.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2020 | Feb 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002653 | Child Behavior Disorders |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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|
| 4 months after inclusion |
| Score at the Emotion Regulation Checklist | 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). | 8 months after inclusion |
| Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported | 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. | 9 months after inclusion |
| Niquille M, Gremion C, Welker S, Damsa C. [Agitation in prehospital setting: view of emergency physicians]. Rev Med Suisse. 2007 Aug 15;3(121):1839-46. French. |
| 17879224 | Background | Tereno S, Soares I, Martins C, Celani M, Sampaio D. Attachment styles, memories of parental rearing and therapeutic bond: a study with eating disordered patients, their parents and therapists. Eur Eat Disord Rev. 2008 Jan;16(1):49-58. doi: 10.1002/erv.801. |
| 26095854 | Background | Lewis GF, Hourani L, Tueller S, Kizakevich P, Bryant S, Weimer B, Strange L. Relaxation training assisted by heart rate variability biofeedback: Implication for a military predeployment stress inoculation protocol. Psychophysiology. 2015 Sep;52(9):1167-74. doi: 10.1111/psyp.12455. Epub 2015 Jun 11. |
| 12149977 | Background | Zeman J, Shipman K, Suveg C. Anger and sadness regulation: predictions to internalizing and externalizing symptoms in children. J Clin Child Adolesc Psychol. 2002 Sep;31(3):393-8. doi: 10.1207/S15374424JCCP3103_11. |
| 26339283 | Background | Chicchi Giglioli IA, Pallavicini F, Pedroli E, Serino S, Riva G. Augmented Reality: A Brand New Challenge for the Assessment and Treatment of Psychological Disorders. Comput Math Methods Med. 2015;2015:862942. doi: 10.1155/2015/862942. Epub 2015 Aug 3. |
| 24624073 | Background | Baus O, Bouchard S. Moving from virtual reality exposure-based therapy to augmented reality exposure-based therapy: a review. Front Hum Neurosci. 2014 Mar 4;8:112. doi: 10.3389/fnhum.2014.00112. eCollection 2014. |
| 23173347 | Background | Gold G, Fazio L, Stolz JH, Herrman FR, Gattelet P, Zekry D. [Assessment of behavior in non-psychiatric settings: use of a simple and reliable method]. Rev Med Suisse. 2012 Nov 7;8(361):2119-21. French. |
| 3418327 | Background | Kay SR, Wolkenfeld F, Murrill LM. Profiles of aggression among psychiatric patients. I. Nature and prevalence. J Nerv Ment Dis. 1988 Sep;176(9):539-46. doi: 10.1097/00005053-198809000-00007. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Home | Count of Participants | Participants |
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| Enrolled in school | Count of Participants | Participants |
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| Reason for hospitalisation | Count of Participants | Participants |
|
| Number of years of inpatient care for children | Mean | Standard Deviation | years |
|
Wards with the "Inner Garden" biofeedback tool
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.)
|
|
| Secondary | Score at the Emotion Regulation Checklist | 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). | Posted | Mean | Standard Deviation | score on a scale | 4 months after inclusion |
|
|
|
| Secondary | Score at the Emotion Regulation Checklist | 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). | Posted | Mean | Standard Deviation | score on a scale | 8 months after inclusion |
|
|
|
| Secondary | Number of Child for Which Assault or Violence Against Health Care Professionals Was Reported | 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. | Posted | Count of Participants | Participants | 9 months after inclusion |
|
|
|
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Inner Garden | Wards with the "Inner Garden" biofeedback tool 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.) | 0 | 33 | 0 | 33 | 0 | 33 |
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| Family home |
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| Other (mental retardation, hyperkinetic, social, adjustment disorders, congenital malformations) |
|
| Observation for suspected psychiatric illness, unspecified |
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| Composite emotional regulation score |
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| Composite emotional regulation score |
|