Psychiatric DisorderNCT05512858
Sensory Room at an Acute Psychiatric Unit
A study testing sensory room in people with Psychiatric Disorder, run by Tel Aviv University at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- sensory room
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Aug 2022to 25 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Hebrew language Proficiency receiving psychiatric medication of any kind regularly for at least 14 days hospitalized in full hospitalization for up to 70 days.
Who cannot join
- chronic pain, neurodevelopmental syndrome active use of psychoactive substances.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychiatric Disorder
- Being tested
- sensory room
- Keywords
- psychiatric disorder, sensory processing, sensory room, seclusion, restraint, aggression, acute psychiatric ward
- Medical subject headings
- Mental Disorders, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory roomBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: sensory room |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
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.
Measured: after every intervention, an average of six months
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.
Measured: during the intervention, an average of six months
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.
Measured: during the intervention, an average of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start28 Aug 2022
- Primary completion25 Jun 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Two phases, First with no intervention (=control group), second with intervention(study group).
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Abarbanel Mental Health Center
- Responsible party
- Principal investigator, Tami Bar-Shalita, Tel Aviv University
- Investigators
- Liron Peretz, BOT, Study chair, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512858
- Sponsor's protocol ID
- 164
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon personal request
Publications
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.
PubMed 19227108Berk 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.
PubMed 18462279de 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.
PubMed 31184379Lifshitz 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.
PubMed 23124009Menghini 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.
PubMed 31332802Nasreddine 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.
PubMed 15817019Salzmann-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.
PubMed 30666885Hedlund 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.
PubMed 30931543Chalmers 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.
PubMed 22357673Wiglesworth 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.
PubMed 27237722
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of a Sensory Room in Reducing Seclusion, Restraint and Aggression at an Acute Psychiatric Unit
- ClinicalTrials.gov ID
- NCT05512858
- Acronym / sponsor ID
- 164
- Conditions
- Psychiatric Disorder
- Keywords
- psychiatric disorder, sensory processing, sensory room, seclusion, restraint, aggression, acute psychiatric ward
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Abarbanel Mental Health Center
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two phases, First with no intervention (=control group), second with intervention(study group).
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: sensory roomData 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Hebrew language Proficiency receiving psychiatric medication of any kind regularly for at least 14 days hospitalized in full hospitalization for up to 70 days.
Key exclusion criteria (1 listed)
- chronic pain, neurodevelopmental syndrome active use of psychoactive substances.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sensory roomthe 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. | Behavioural | phase 2 |
Primary outcome
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.
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.
3 secondary outcomes
Interview - qualitative measure
Time frame: after every intervention, an average of six months
Emptica-E4- physiological parameter (EDM)
Time frame: during the intervention, an average of six months
Emptica-E4- physiological parameter (PPG)
Time frame: during the intervention, an average of six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 19227108Barton 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.
- Background: PubMed 18462279Berk 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.
- Background: PubMed 31184379de 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.
- Background: PubMed 23124009Lifshitz 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.
- Background: PubMed 31332802Menghini 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.
- Background: PubMed 15817019Nasreddine 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.
- Background: PubMed 30666885Salzmann-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.
- Background: PubMed 30931543Hedlund 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.
- Background: PubMed 22357673Chalmers 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.
- Background: PubMed 27237722Wiglesworth 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.
- Skin conductance, heart rate and aggressive behavior typeLink provided by the sponsor.
- Sensory modulation disorder (SMD) and pain: a new perspective.Link provided by the sponsor.
- The effects of the use of the sensory room in psychiatryLink provided by the sponsor.
- The responsiveness of the Hamilton depression rating scale.Link provided by the sponsor.
- Predicting Depression and Anxiety Mood by Wrist-Worn Sleep SensorLink provided by the sponsor.
- Autonomic nervous system activity in emotion: A reviewLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be available upon personal request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liron Peretz, BOT study chair
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensory room in people with Psychiatric Disorder, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of restrictions (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05512858, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.