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

Not yet recruiting

• Conditions: Child Behavior Disorders
• Interventions: Device: 'Fitbit charge 4' 'smart-watch'-

• Registration Number: NCT06474702
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-23
• Last Update Submitted: 2024-06-23
• Study First Posted: 2024-06-26
• Last Update Posted: 2024-06-26
• Study Start: 2024-07-01
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study arm	'Fitbit charge 4' 'smart-watch'-	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.

Primary Outcome Measures

Name	Time	Method
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.
physiological parameter	12 months (july 2024-july 2025)	sleep patterns, the data of sleep pattern is based on movements (outcome 5) and heart rate (outcome 1)

Secondary Outcome Measures

Name	Time	Method
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.