Psychiatric Disorder
Conditions
Keywords
psychiatric disorder, sensory processing, sensory room, seclusion, restraint, aggression, acute psychiatric ward
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.
Interventions
BEHAVIORALsensory 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.
Sponsors
Abarbanel Mental Health Center
Tel Aviv University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Two phases, First with no intervention (=control group), second with intervention(study group).
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of restrictions | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Interview - qualitative measure | 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. |
| Emptica-E4- physiological parameter (EDM) | 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. |
| Emptica-E4- physiological parameter (PPG) | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression (CGI) | 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. |
| The Sensory Responsiveness Questionnaire Intensity Scale (SRQ-IS) | 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. |
| Montreal Cognitive Assessment (MoCA) | 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. |
| Pain Sensitivity Questionnaire (PSQ) | 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. |
| State-Trait Anxiety Inventory (STAI) | 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. |
Countries
Israel
Outcome results
None listed