Predicting Violent Outburst in Inpatient Pediatric Psychiatry Ward Using a Wearable Device.

NCT ID: NCT06474702

Last Updated: 2024-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-07-01

Brief Summary

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The investigator will investigate the use of non-invasive wearable device physiological measures. this in order to predict aggression, and violence outburst in children under 12 years old, which are admitted at an inpatient psychiatric ward. also, the investigator will try to do a characterization of those physiological measures in the prediction of aggression and violence outbursts.

Detailed Description

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Conditions

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Child Behavior Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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study arm

the investigator will utilize "Fitbit-Charge 4" a wearable 'smart-watch' in order to collect patients' physiological measurements, including continuous heart rate, heart-rate variability and breathing rate, as well as behavioral measurements such as movements and sleep pattern in order to predict aggression and violence outburst in children under 12 years old admitted at an inpatient psychiatric ward and characterization of those physiological measures in the prediction of aggression and violence outbursts.

'Fitbit charge 4' 'smart-watch'-

Intervention Type DEVICE

smartwatch device that collects physiological measures

Interventions

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'Fitbit charge 4' 'smart-watch'-

smartwatch device that collects physiological measures

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* the investigator will include patients under the age of 13 with various mental disorders admitted to our inpatient psychiatry ward at 'Edmond and Lily Safra' Children's Hospital, Sheba Medical Centre, Tel Hashomer, Ramat Gan, Israel during 2024.

Exclusion Criteria

* the investigator will exclude patients that were hospitalized but did not want to participate, or couldn't participate due to increased sensorial sensitive to the device. the investigator will exclude patients with no violence outburst or aggressive attitude that were hospitalized at our inpatient psychiatric ward during 2024. additional, patients who suffers dermatological illnesses and might show allergic reactions to the device material on their wrist will be excluded.
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Doron Gothelf MD

head of child and adolescent psychiatry division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doron Gothelf, M.D

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Central Contacts

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Doron Gothelf, M.D

Role: CONTACT

+972526669360

Other Identifiers

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1135-24-SMC

Identifier Type: -

Identifier Source: org_study_id

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