ClinicalTrials.gg
Not yet recruitingNCT06474702Updated Jun 26, 2024

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

An observational study in Child Behavior Disorders, sponsored by Sheba Medical Center. Not yet recruiting. Open to participants aged 6 Years to 13 Years. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by Sheba Medical Center · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
30
Ages
6 Years to 13 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Child Behavior Disorders
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In context

Child Behavior Disorders

35 studies on the registry are indexed under Child Behavior Disorders; 10 are open to participants now.

This study's planned enrollment of 30 is below the median of 350 across 10 observational studies indexed under Child Behavior Disorders.

Browse Child Behavior Disorders studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

children with mental ilnesses hospitalized at out inpatient psychiatric ward

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Device'Fitbit charge 4' 'smart-watch'-

    smartwatch device that collects physiological measures

06

What researchers measure

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)

  5. 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.

    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)

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2024; primary completion for Jul 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2024
First posted
Jun 26, 2024
StartEst.
Jul 1, 2024
Primary completionEst.
Jul 1, 2025
CompletionEst.
Jul 1, 2026
Last update
Jun 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06474702
Responsible party
Prof. Doron Gothelf MD (head of child and adolescent psychiatry division, Sheba Medical Center) — Principal investigator
First posted
Jun 26, 2024
Start date
Jul 1, 2024 (estimated)
Primary completion
Jul 1, 2025 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Jun 26, 2024

Study contacts

Doron Gothelf, M.D
Contact
doron.gothelf@sheba.health.gov.il
+972526669360
Doron Gothelf, M.D
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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