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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06474702
Enrollment
30
Registered
2024-06-26
Start date
2024-07-01
Completion date
2026-07-01
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Behavior Disorders

Brief summary

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.

Interventions

DEVICE'Fitbit charge 4' 'smart-watch'-

smartwatch device that collects physiological measures

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
physiological parameter12 months (july 2024-july 2025)Heart rate
movements.12 months (july 2024-july 2025)movements frequency of the patient, collected by the smart-watch using 3 axis-accelerometer that can detect movements in 3 dimensions. for example, number of steps taken.

Secondary

MeasureTime frameDescription
violence assessment with 'MOAS' score system.12 months (july 2024-july 2025)using 'MOAS', the Modified Overt Aggression Scale score system filled by the department staff manually on each day and outburst description. the score system is made up of four categories (verbal aggression, aggression against objects, aggression against self, and aggression against others. each category is ranked by numbers. range of total score is between 0-40. higher score usually higher than 20 indicating more aggressive behavior which means worse outcome.

Contacts

Primary ContactDoron Gothelf, M.D
doron.gothelf@sheba.health.gov.il+972526669360

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026