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

S

Sheba Medical Center

Status

Not yet enrolling

Conditions

Child Behavior Disorders

Treatments

Device: 'Fitbit charge 4' 'smart-watch'-

Study type

Observational

Funder types

Other

Identifiers

NCT06474702
1135-24-SMC

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

6 to 13 years old

Volunteers

No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

study arm
Description:
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.
Treatment:
Device: 'Fitbit charge 4' 'smart-watch'-

Trial contacts and locations

0

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Central trial contact

Doron Gothelf, M.D

Data sourced from clinicaltrials.gov

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