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Completed

NCT Number: NCT05512858

Sensory Room 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.

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Key information

Conditions

Psychiatric Disorder Aberrant Motor Behavior in Dementia Aggression Behavior Behavioral Symptoms Mental Disorders Social Behavior

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Abarbanel Mental Health Center

Bat Yam, 5943601, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Interview - qualitative measure

    Time frame: after every intervention, an average of six months

    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.

  2. Emptica-E4- physiological parameter (EDM)

    Time frame: during the intervention, an average of six months

    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.

  3. Emptica-E4- physiological parameter (PPG)

    Time frame: during the intervention, an average of six months

    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.

Other outcomes

  1. Clinical Global Impression (CGI)

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

    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.

  2. Montreal Cognitive Assessment (MoCA)

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

    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.

  3. The Sensory Responsiveness Questionnaire Intensity Scale (SRQ-IS)

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

    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.

  4. Pain Sensitivity Questionnaire (PSQ)

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

    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.

  5. State-Trait Anxiety Inventory (STAI)

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

    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.

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Collaborators

  • Abarbanel Mental Health Center

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2022
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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