Sensory Room at an Acute Psychiatric Unit

NCT ID: NCT05512858

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-28
• Study Completion Date: 2023-06-25

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:

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.

Conditions

Psychiatric Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

sensory room

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Abarbanel Mental Health Center

OTHER_GOV

Sponsor Role: collaborator

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Tami Bar-Shalita

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liron Peretz, BOT

Role: STUDY_CHAIR

Tel Aviv University

Locations

Abarbanel Mental Health Center

Bat Yam, , Israel

Countries

Israel

References

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Related Links

http://doi.org/10.1016/j.biopsycho.2018.12.012

Skin conductance, heart rate and aggressive behavior type

http://doi.org/10.3389/fnint.2019.00027

Sensory modulation disorder (SMD) and pain: a new perspective.

http://www.ot-innovations.com/wp-ontent/uploads/2014/09/qi_study_sensory_room.pdf

The effects of the use of the sensory room in psychiatry

http://doi.org/10.1016/S0022-3956(99)00037-0

The responsiveness of the Hamilton depression rating scale.

http://doi.org/10.1109/PerComWorkshops48775.2020.9156176

Predicting Depression and Anxiety Mood by Wrist-Worn Sleep Sensor

http://doi.org/10.1016/j.biopsycho.2010.03.010

Autonomic nervous system activity in emotion: A review

http://doi.org/10.1038/sj.npp.1301147

Linking the PANSS, BPRS, and CGI: clinical implications

http://doi.org/10.1109/EMBSISC.2016.7508621

Validation of the Empatica E4 wristband.

http://doi.org/10.1016/j.pain.2009.06.020

Pain sensitivity can be assessed by self-rating: Development and validation of the Pain Sensitivity Questionnaire

http://doi.org/10.1007/s10916-020-01648-w

Validity of the Empatica E4 Wristband to Measure Heart Rate Variability (HRV) Parameters: A Comparison to Electrocardiography (ECG).

http://doi.org/10.1016/j.pnpbp.2017.05.012

Epidemiology of pain and relation to psychiatric disorders.

http://doi.org/10.1109/CSCWD.2016.7566067

Wearable devices and their applications in surgical robot control and p-medicine

http://doi.org/10.1016/j.comppsych.2014.12.009

Sensory modulation and daily-life participation in people with schizophrenia.

Other Identifiers

164

Identifier Type: -

Identifier Source: org_study_id