Sensory Room at an Acute Psychiatric Unit

July 29, 2023 updated by: Tami Bar-Shalita, Tel Aviv University

Exploring the Effectiveness of a Sensory Room in Reducing Seclusion, Restraint and Aggression at an Acute Psychiatric Unit

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Bat Yam, Israel, 5943601
        • Abarbanel Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: phase 1
Data on restrictions and aggression events in the department will be collected throughout the two phases, and the participants will undergo an evaluation process.
Experimental: phase 2
Data 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.
Behavioral: sensory room
the room has dimmed lighting, sensing games, essential oils, picture books and cookbooks, two heavy blankets (weighing 9 kg and 11 kg), a rocking chair, and a vestibular plate. The occupational therapist will accompany the first entry into the room to create a sensory profile, adjust and instruct on the means, and write a treatment card. The treatment card will record the patient's choices and instructions for arranging the room, and it will be used by the staff members who will admit the patient as needed. Each patient will be able to stay in the room for self-treatment according to the individual treatment card prepared at the first sensory room treatment, up to half an hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of restrictions
Time Frame: through 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.
through study completion, an average of 1 year
Number of aggression events
Time Frame: through 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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interview - qualitative measure
Time Frame: after 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.
after every intervention, an average of six months
Emptica-E4- physiological parameter (EDM)
Time Frame: 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.
during the intervention, an average of six months
Emptica-E4- physiological parameter (PPG)
Time Frame: 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.
during the intervention, an average of six months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression (CGI)
Time Frame: through study completion, an average of 1 year. Will be filled out for each participant once
A reliable and valid standard evaluation designed to assess the severity of psychiatric illness. The tool consists of three items: CGI-Severity of Illness (CGI-S), CGI-Global Improvement, and CGI-Efficacy Index ; only CGI-S will be used in this study. The psychiatrist should indicate in the range between 1 ("normal, no evidence of disease") and 7 ("among the most severe cases of patients") the patient's condition compared to patients with the same diagnosis with regards to the following parameters: symptoms, behavior, and function in the last week.
through study completion, an average of 1 year. Will be filled out for each participant once
Montreal Cognitive Assessment (MoCA)
Time Frame: through study completion, an average of 1 year. Each participant will answer once
A 10-minute cognitive screening tool assessment for detecting cognitive impairment. The MoCA items include short term memory recall, visuospatial ability, executive function, attention-concentration-working memory, language, and orientation to time and place.
through study completion, an average of 1 year. Each participant will answer once
The Sensory Responsiveness Questionnaire Intensity Scale (SRQ-IS)
Time Frame: through study completion, an average of 1 year. Each participant will answer once
A 58-item questionnaire aimed at clinically classifying sensory modulation dysfunction in adults. Items represent typical daily life situations involving auditory, visual, gustatory, olfactory, vestibular and somatosensory sensations, excluding pain. Items are phrased either in a hedonic or aversive valence and are graded on a 5-point Likert scale: 'not at all' (1) to 'very much' (5). Two cut-off scores are provided.
through study completion, an average of 1 year. Each participant will answer once
Pain Sensitivity Questionnaire (PSQ)
Time Frame: through study completion, an average of 1 year. Each participant will answer once
A 17 item questionnaire aimed to quantify everyday somatosensory pain sensitivity to imagined painful daily life situations. Participants rate the intensity of imagined pain on a 10-point scale: 'not painful at all' (0) to 'the worst pain imaginable' (10). The Pain Sensitivity Questionnaire provides a total score and two sub-scores.
through study completion, an average of 1 year. Each participant will answer once
State-Trait Anxiety Inventory (STAI)
Time Frame: through study completion, an average of 1 year. Each participant will answer once
Self-report questionnaire designed to determine the anxiety level of a patient and divides anxiety into state and trait anxieties. This study will use STAI-T only. Trait anxiety is the presence of disproportionately long-term and severe anxiety related to an objective cause. STAI has 20 items, each item is rated on a scale of 1 to 4, and the sum of all items determines the anxiety level. A score in the range of 20-80 is considered a high score and indicates intense anxiety.
through study completion, an average of 1 year. Each participant will answer once

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel Aviv University

Collaborators

Abarbanel Mental Health Center

Investigators

  • Study Chair: Liron Peretz, BOT, Tel Aviv University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2022

Primary Completion (Actual)

June 25, 2023

Study Completion (Actual)

June 25, 2023

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

August 21, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 29, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon personal request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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