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

NCT04610281 | Completed Results

• 1 other identifier: 2019/P08/360
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Behavior Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Score at the Emotion Regulation Checklist

  4 months after inclusion

• Score at the Emotion Regulation Checklist

  8 months after inclusion

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

  9 months after inclusion

Study Arms (2)

Control

NO INTERVENTION

Wards without the "Inner Garden" biofeedback tool

Inner Garden

EXPERIMENTAL

Wards with the "Inner Garden" biofeedback tool

Device: Inner Garden

Interventions

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.)

Inner Garden

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Refusal to participate on the part of the child and/or legal representative(s).

Sponsors & Collaborators

• Groupe Hospitalier de la Rochelle Ré Aunis: lead
• Ullo World: collaborator

Study Sites (1)

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

Location

Related Publications (9)

• 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.

  PMID: 32549935 BACKGROUND

• 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.

  PMID: 17892148 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.

  PMID: 17879224 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.

  PMID: 26095854 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.

  PMID: 12149977 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.

  PMID: 26339283 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.

  PMID: 24624073 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.

  PMID: 23173347 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.

  PMID: 3418327 BACKGROUND

MeSH Terms

Conditions

Child Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Brigitte Laurent
• Organization: Ullo World

brigitte@ullo.fr

+33782096875

Study Officials

• Nordine Benmabrouk, RN

  Groupe Hospitalier de la Rochelle Ré Aunis

  STUDY DIRECTOR

• Brigitte Laurent, PhD

  Ullo World

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: November 2, 2020
• Primary Completion: July 6, 2021
• Study Completion: July 6, 2021
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• 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

Locations

FR (1)