Sensory Room at an Acute Psychiatric Unit

Psychiatric Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05512858
• Other study ID #: 164
• Status: Completed
• Phase: N/A
• Start date: August 28, 2022
• Est. completion date: June 25, 2023

Study information

• Verified date: July 2023
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 25, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

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.

Locations

Country	Name	City	State
Israel	Abarbanel Mental Health Center	Bat Yam

Sponsors (2)

Lead Sponsor	Collaborator
Tel Aviv University	Abarbanel Mental Health Center

Country where clinical trial is conducted

Israel, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Wiglesworth S, Farnworth L. An Exploration of the Use of a Sensory Room in a Forensic Mental Health Setting: Staff and Patient Perspectives. Occup Ther Int. 2016 Sep;23(3):255-64. doi: 10.1002/oti.1428. Epub 2016 May 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Global Impression (CGI)	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
Other	Montreal Cognitive Assessment (MoCA)	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
Other	The Sensory Responsiveness Questionnaire Intensity Scale (SRQ-IS)	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
Other	Pain Sensitivity Questionnaire (PSQ)	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
Other	State-Trait Anxiety Inventory (STAI)	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
Primary	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.	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year
Secondary	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.	after every intervention, an average of six months
Secondary	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.	during the intervention, an average of six months
Secondary	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.	during the intervention, an average of six months

External Links

•   Autonomic nervous system activity in emotion: A review
•   Epidemiology of pain and relation to psychiatric disorders.
•   Linking the PANSS, BPRS, and CGI: clinical implications
•   Pain sensitivity can be assessed by self-rating: Development and validation of the Pain Sensitivity Questionnaire
•   Predicting Depression and Anxiety Mood by Wrist-Worn Sleep Sensor
•   Sensory modulation and daily-life participation in people with schizophrenia.
•   Sensory modulation disorder (SMD) and pain: a new perspective.
•   Skin conductance, heart rate and aggressive behavior type
•   The effects of the use of the sensory room in psychiatry
•   The responsiveness of the Hamilton depression rating scale.
•   Validation of the Empatica E4 wristband.
•   Validity of the Empatica E4 Wristband to Measure Heart Rate Variability (HRV) Parameters: A Comparison to Electrocardiography (ECG).
•   Wearable devices and their applications in surgical robot control and p-medicine