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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Child Behavior Disorders
• Intervention / Treatment: Device: 'Fitbit charge 4' 'smart-watch'-

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Doron Gothelf, M.D; Phone Number: +972526669360; Email: doron.gothelf@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

children with mental ilnesses hospitalized at out inpatient psychiatric ward

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: 'Fitbit charge 4' 'smart-watch'-; smartwatch device that collects physiological measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physiological parameter	Heart rate	12 months (july 2024-july 2025)
physiological parameter	heart rate variability, the data of heart rate variability is based on respiratory rate (outcome 3) and heart rate (outcome 1)	12 months (july 2024-july 2025)
physiological parameter	respiratory rate	12 months (july 2024-july 2025)
physiological parameter	sleep patterns, the data of sleep pattern is based on movements (outcome 5) and heart rate (outcome 1)	12 months (july 2024-july 2025)
movements.	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.	12 months (july 2024-july 2025)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
violence assessment with 'MOAS' score system.	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.	12 months (july 2024-july 2025)

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: Doron Gothelf, M.D, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 23, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 23, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurodevelopmental Disorders; Mental Disorders; Child Behavior Disorders
• Other Study ID Numbers: 1135-24-SMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No