Clinical trial NCT05512858: Sensory Room at an Acute Psychiatric Unit
Official title: Exploring the Effectiveness of a Sensory Room in Reducing Seclusion, Restraint and Aggression at an Acute Psychiatric Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric Disorder
Keywords: psychiatric disorder
sensory processing
sensory room
seclusion
restraint
aggression
acute psychiatric ward
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Abarbanel Mental Health Center
First posted: 2022-08-23
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Two phases, First with no intervention (=control group), second with intervention(study group).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of restrictions
timeFrame: through study completion, an average of 1 year
measure: Number of aggression events
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Interview - qualitative measure
timeFrame: after every intervention, an average of six months
measure: Emptica-E4- physiological parameter (EDM)
timeFrame: during the intervention, an average of six months
measure: Emptica-E4- physiological parameter (PPG)
timeFrame: during the intervention, an average of six months
Other outcomes:
measure: Clinical Global Impression (CGI)
timeFrame: through study completion, an average of 1 year. Will be filled out for each participant once
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: through study completion, an average of 1 year. Each participant will answer once
measure: The Sensory Responsiveness Questionnaire Intensity Scale (SRQ-IS)
timeFrame: through study completion, an average of 1 year. Each participant will answer once
measure: Pain Sensitivity Questionnaire (PSQ)
timeFrame: through study completion, an average of 1 year. Each participant will answer once
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: through study completion, an average of 1 year. Each participant will answer once
Locations:
city: Bat Yam
country: Israel
facility: Abarbanel Mental Health Center
Study officials:
affiliation: Tel Aviv University
name: Liron Peretz, BOT
role: STUDY_CHAIR
References:
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