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Sensory Room at an Acute Psychiatric Unit

Primary Purpose

Psychiatric Disorder

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
sensory room
Sponsored by
Tel Aviv University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Psychiatric Disorder focused on measuring psychiatric disorder, sensory processing, sensory room, seclusion, restraint, aggression, acute psychiatric ward

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Abarbanel Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

phase 1

phase 2

Arm Description

Data on restrictions and aggression events in the department will be collected throughout the two phases, and the participants will undergo an evaluation process.

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.

Outcomes

Primary Outcome Measures

Number of restrictions
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 events
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

Interview - qualitative measure
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)
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)
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.

Full Information

First Posted
July 25, 2022
Last Updated
July 29, 2023
Sponsor
Tel Aviv University
Collaborators
Abarbanel Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05512858
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 28, 2022 (Actual)
Primary Completion Date
June 25, 2023 (Actual)
Study Completion Date
June 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
Collaborators
Abarbanel Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Without intervention (control group). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder
Keywords
psychiatric disorder, sensory processing, sensory room, seclusion, restraint, aggression, acute psychiatric ward

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Two phases, First with no intervention (=control group), second with intervention(study group).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
phase 1
Arm Type
No Intervention
Arm Description
Data on restrictions and aggression events in the department will be collected throughout the two phases, and the participants will undergo an evaluation process.
Arm Title
phase 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
sensory room
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of restrictions
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Number of aggression events
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Interview - qualitative measure
Description
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.
Time Frame
after every intervention, an average of six months
Title
Emptica-E4- physiological parameter (EDM)
Description
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.
Time Frame
during the intervention, an average of six months
Title
Emptica-E4- physiological parameter (PPG)
Description
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.
Time Frame
during the intervention, an average of six months
Other Pre-specified Outcome Measures:
Title
Clinical Global Impression (CGI)
Description
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.
Time Frame
through study completion, an average of 1 year. Will be filled out for each participant once
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
through study completion, an average of 1 year. Each participant will answer once
Title
The Sensory Responsiveness Questionnaire Intensity Scale (SRQ-IS)
Description
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.
Time Frame
through study completion, an average of 1 year. Each participant will answer once
Title
Pain Sensitivity Questionnaire (PSQ)
Description
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.
Time Frame
through study completion, an average of 1 year. Each participant will answer once
Title
State-Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
through study completion, an average of 1 year. Each participant will answer once

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liron Peretz, BOT
Organizational Affiliation
Tel Aviv University
Official's Role
Study Chair
Facility Information:
Facility Name
Abarbanel Mental Health Center
City
Bat Yam
ZIP/Postal Code
5943601
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon personal request
Citations:
PubMed Identifier
19227108
Citation
Barton SA, Johnson MR, Price LV. Achieving restraint-free on an inpatient behavioral health unit. J Psychosoc Nurs Ment Health Serv. 2009 Jan;47(1):34-40. doi: 10.3928/02793695-20090101-01.
Results Reference
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18462279
Citation
Berk M, Ng F, Dodd S, Callaly T, Campbell S, Bernardo M, Trauer T. The validity of the CGI severity and improvement scales as measures of clinical effectiveness suitable for routine clinical use. J Eval Clin Pract. 2008 Dec;14(6):979-83. doi: 10.1111/j.1365-2753.2007.00921.x. Epub 2008 May 2.
Results Reference
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PubMed Identifier
31184379
Citation
de Looff P, Noordzij ML, Moerbeek M, Nijman H, Didden R, Embregts P. Changes in heart rate and skin conductance in the 30 min preceding aggressive behavior. Psychophysiology. 2019 Oct;56(10):e13420. doi: 10.1111/psyp.13420. Epub 2019 Jun 11.
Results Reference
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PubMed Identifier
23124009
Citation
Lifshitz M, Dwolatzky T, Press Y. Validation of the Hebrew version of the MoCA test as a screening instrument for the early detection of mild cognitive impairment in elderly individuals. J Geriatr Psychiatry Neurol. 2012 Sep;25(3):155-61. doi: 10.1177/0891988712457047.
Results Reference
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PubMed Identifier
31332802
Citation
Menghini L, Gianfranchi E, Cellini N, Patron E, Tagliabue M, Sarlo M. Stressing the accuracy: Wrist-worn wearable sensor validation over different conditions. Psychophysiology. 2019 Nov;56(11):e13441. doi: 10.1111/psyp.13441. Epub 2019 Jul 23.
Results Reference
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PubMed Identifier
15817019
Citation
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
Results Reference
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PubMed Identifier
30666885
Citation
Salzmann-Erikson M, Yifter L. Risk Factors and Triggers That May Result in Patient-Initiated Violence on Inpatient Psychiatric Units: An Integrative Review. Clin Nurs Res. 2020 Sep;29(7):504-520. doi: 10.1177/1054773818823333. Epub 2019 Jan 22.
Results Reference
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PubMed Identifier
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Citation
Hedlund Lindberg M, Samuelsson M, Perseius KI, Bjorkdahl A. The experiences of patients in using sensory rooms in psychiatric inpatient care. Int J Ment Health Nurs. 2019 Aug;28(4):930-939. doi: 10.1111/inm.12593. Epub 2019 Mar 31.
Results Reference
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PubMed Identifier
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Citation
Chalmers A, Harrison S, Mollison K, Molloy N, Gray K. Establishing sensory-based approaches in mental health inpatient care: a multidisciplinary approach. Australas Psychiatry. 2012 Feb;20(1):35-9. doi: 10.1177/1039856211430146. Epub 2012 Jan 5.
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Results Reference
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Links:
URL
http://doi.org/10.1016/j.biopsycho.2018.12.012
Description
Skin conductance, heart rate and aggressive behavior type
URL
http://doi.org/10.3389/fnint.2019.00027
Description
Sensory modulation disorder (SMD) and pain: a new perspective.
URL
http://www.ot-innovations.com/wp-ontent/uploads/2014/09/qi_study_sensory_room.pdf
Description
The effects of the use of the sensory room in psychiatry
URL
http://doi.org/10.1016/S0022-3956(99)00037-0
Description
The responsiveness of the Hamilton depression rating scale.
URL
http://doi.org/10.1109/PerComWorkshops48775.2020.9156176
Description
Predicting Depression and Anxiety Mood by Wrist-Worn Sleep Sensor
URL
http://doi.org/10.1016/j.biopsycho.2010.03.010
Description
Autonomic nervous system activity in emotion: A review
URL
http://doi.org/10.1038/sj.npp.1301147
Description
Linking the PANSS, BPRS, and CGI: clinical implications
URL
http://doi.org/10.1109/EMBSISC.2016.7508621
Description
Validation of the Empatica E4 wristband.
URL
http://doi.org/10.1016/j.pain.2009.06.020
Description
Pain sensitivity can be assessed by self-rating: Development and validation of the Pain Sensitivity Questionnaire
URL
http://doi.org/10.1007/s10916-020-01648-w
Description
Validity of the Empatica E4 Wristband to Measure Heart Rate Variability (HRV) Parameters: A Comparison to Electrocardiography (ECG).
URL
http://doi.org/10.1016/j.pnpbp.2017.05.012
Description
Epidemiology of pain and relation to psychiatric disorders.
URL
http://doi.org/10.1109/CSCWD.2016.7566067
Description
Wearable devices and their applications in surgical robot control and p-medicine
URL
http://doi.org/10.1016/j.comppsych.2014.12.009
Description
Sensory modulation and daily-life participation in people with schizophrenia.

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Sensory Room at an Acute Psychiatric Unit

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