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Sensory Room at an Acute Psychiatric Unit

Not Applicable
Completed
Conditions
Psychiatric Disorder
Interventions
Behavioral: sensory room
Registration Number
NCT05512858
Lead Sponsor
Tel Aviv University
Brief Summary

the aim of the presented study is to explore the effectiveness of a sensory room in reducing seclusion, restraint and aggression at an acute psychiatric ward.

Detailed Description

Background In recent years, there has been an increase in violence in mental health centers in Israel. Until recently, the phenomenon was treated under mechanical restrictions and patient isolation. Today the trend is to reduce the use of restrictions, with the main alternative being the provision of medication and de-escalation techniques, one of which is sensory stimulation using sensory rooms. A sensory room in the psychiatric unit has been found as an effective intervention for reducing patients' distress and aggression. However, the effectiveness of using the room has not yet been studied in Israel and in relation to pain.

Method

The experimental study will be conducted in two phases each lasting three months in an acute psychiatric ward:

1. Without intervention (control group).

2. With intervention. Data on restrictions and aggression events will be collected throughout the two phases, and the participants will undergo an evaluation process using self reports.

In addition,subjects who will participate in the intervention (study group) will wear an Empatica-E4 wristband to monitor autonomous metrics during their stay in the sensory stimulation room and will undergo a brief interview regarding their experience using the room.Thus the intervention phase (Study group) will comprise mixed methods.

Population Eighty men aged 18-50, a convenience sample, who speaks Hebrew; treated with psychiatric medication for at least two weeks; and hospitalized for up to 70 days.

Expected results:

Statistical significant group differences will be found in the sum of ward restrictions (i.e., sedatives, physical restraint, and seclusion), showing less during phase 2 (study group): The study group (2nd phase) will receive fewer sedatives and use less physical restraint and seclusion.

Statistical significant group differences will be found in the aggression incidents showing fewer reports of aggression in the study group.

Statistical significant differences will be found in the HRV indices between pre and post sensory room treatment, showing reduced values post treatment.

statistically significant correlations will be found between sensory over-responsivity and the number of aggression events so that higher sensory responsiveness (SOR) will be correlated with more aggression events.

statistically significant correlations will be found between sensitivity to pain and the number of aggression incidents: higher pain sensitivity will be correlated with fewer incidents of aggression.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
80
Inclusion Criteria
  • Hebrew language Proficiency receiving psychiatric medication of any kind regularly for at least 14 days hospitalized in full hospitalization for up to 70 days.
Exclusion Criteria
  • chronic pain, neurodevelopmental syndrome active use of psychoactive substances.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
phase 2sensory roomData on restrictions and aggression events in the department will be collected throughout the two phases, and the participants will undergo an evaluation process. n addition, the subjects who participate in the intervention will wear an Empatica-E4 wristband to monitor autonomous metrics during their stay in the sensory stimulation room and will undergo a brief interview regarding their experience using the room.
Primary Outcome Measures
NameTimeMethod
Number of restrictionsthrough study completion, an average of 1 year

In this study, restrictions are defined as incidents of entering confinement in an isolation room and as taking additional sedative medication. The data collection for the entrance to isolation and tying rooms will be done through a tying notebook managed by the nursing staff; in the notebook, the events are recorded and signed by a doctor. Monitoring of taking the additional drug treatment will be done through the center's computerized system.

Number of aggression eventsthrough study completion, an average of 1 year

Aggression incidents are "exceptional incidents" in the ward, an incident in which a person or an object was harmed. These events are logged in the center's computer system.

Secondary Outcome Measures
NameTimeMethod
Interview - qualitative measureafter every intervention, an average of six months

In order to understand the subject's experience of using the room, an occupational therapist will conduct a semi-structured five-question interview when the subject leaves the sensory stimulation room.

Emptica-E4- physiological parameter (EDM)during the intervention, an average of six months

A medical-grade wearable device that offers real-time physiological data acquisition. Wearable tool, bracelet, battery chargedwill be used to measure electrodermal activity (EDM). Data will automatically be uploaded to E4 connect, a cloud platform after the session ends. The analysis will be done using Kubios software.

Emptica-E4- physiological parameter (PPG)during the intervention, an average of six months

A medical-grade wearable device that offers real-time physiological data acquisition. Wearable tool, bracelet, battery charged, will be used to measure Blood Volume Pulse (BVP), from which heart rate variability can be derived. Data will automatically be uploaded to E4 connect, a cloud platform after the session ends. The analysis will be done using Kubios software.

Trial Locations

Locations (1)

Abarbanel Mental Health Center

🇮🇱

Bat Yam, Israel

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