Sensory Room at an Acute Psychiatric Unit

NCT05512858 | Completed DMC

• 1 other identifier: 164
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychiatric Disorder

Keywords

psychiatric disorder; sensory processing; sensory room; seclusion; restraint; aggression; acute psychiatric ward

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Interview - qualitative measure

  after every intervention, an average of six months

• Emptica-E4- physiological parameter (EDM)

  during the intervention, an average of six months

• Emptica-E4- physiological parameter (PPG)

  during the intervention, an average of six months

Other Outcomes (5)

• Clinical Global Impression (CGI)

  through study completion, an average of 1 year. Will be filled out for each participant once

• Montreal Cognitive Assessment (MoCA)

  through study completion, an average of 1 year. Each participant will answer once

• The Sensory Responsiveness Questionnaire Intensity Scale (SRQ-IS)

  through study completion, an average of 1 year. Each participant will answer once

Study Arms (2)

phase 1

NO INTERVENTION

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

phase 2

EXPERIMENTAL

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

Interventions

sensory room BEHAVIORAL

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.

phase 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Hebrew language Proficiency receiving psychiatric medication of any kind regularly for at least 14 days hospitalized in full hospitalization for up to 70 days.

You may not qualify if:

• chronic pain, neurodevelopmental syndrome active use of psychoactive substances.

Sponsors & Collaborators

• Tel Aviv University: lead
• Abarbanel Mental Health Center: collaborator

Study Sites (1)

Abarbanel Mental Health Center

Bat Yam, 5943601, Israel

Location

Related 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.

  PMID: 19227108 BACKGROUND

• 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.

  PMID: 18462279 BACKGROUND

• 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.

  PMID: 31184379 BACKGROUND

• 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.

  PMID: 23124009 BACKGROUND

• 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.

  PMID: 31332802 BACKGROUND

• 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.

  PMID: 15817019 BACKGROUND

• 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.

  PMID: 30666885 BACKGROUND

• 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.

  PMID: 30931543 BACKGROUND

• 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.

  PMID: 22357673 BACKGROUND

• 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.

  PMID: 27237722 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Mental Disorders; Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Liron Peretz, BOT

  Tel Aviv University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two phases, First with no intervention (=control group), second with intervention(study group).

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 23, 2022
• Study Start: August 28, 2022
• Primary Completion: June 25, 2023
• Study Completion: June 25, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)