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

NCT06474702 | Not Yet Recruiting

• 1 other identifier: 1135-24-SMC
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Child Behavior Disorders

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• violence assessment with 'MOAS' score system.

  12 months (july 2024-july 2025)

Study Arms (1)

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'-

Interventions

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

smartwatch device that collects physiological measures

study arm

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children with mental ilnesses hospitalized at out inpatient psychiatric ward

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Child Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Doron Gothelf, M.D

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doron Gothelf, M.D

CONTACT

+972526669360; doron.gothelf@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of child and adolescent psychiatry division

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 26, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share