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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-13
SponsorSheba Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

children with mental ilnesses hospitalized at out inpatient psychiatric ward

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

  • 'Fitbit charge 4' 'smart-watch'-

    Device

    smartwatch device that collects physiological measures

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: study arm1 intervention

Trial outcomes

Primary outcomes

1

physiological parameter

Heart rate

Time frame
12 months (july 2024-july 2025)
2

physiological parameter

heart rate variability, the data of heart rate variability is based on respiratory rate (outcome 3) and heart rate (outcome 1)

Time frame
12 months (july 2024-july 2025)
3

physiological parameter

respiratory rate

Time frame
12 months (july 2024-july 2025)
4

physiological parameter

sleep patterns, the data of sleep pattern is based on movements (outcome 5) and heart rate (outcome 1)

Time frame
12 months (july 2024-july 2025)

Secondary outcomes

1

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.

Time frame
12 months (july 2024-july 2025)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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