Efficacy of a Sensory Comfort Room in Agitation Control
NCT Number: NCT06547671
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Disorders, Severe
Interventions: OTHER: Employment of a confort room to help in anxiety and agitation moments.
Sponsor: Bioaraba Health Research Institute
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-05-01
Completion Date: 2023-05-01
Locations: Araba University Hospital, Vitoria-gasteiz, Alava, Spain

Summary:
In the initial approach of the study, it was considered that the comfort room would be used by all patients with GCT treated in the Functional Rehabilitation Area 1 (ARF 1) of the Álava Psychiatric Hospital. However, with the onset of the covid-19 pandemic, the service itself decided to separate the patients into two units, in order to reduce positive contacts. Consequently, the use of the comfort room will only be available for one of the two units, which will be considered as the intervention group, while the other unit will be considered as the control group. It is also important to note that the patients in the intervention group unit have a more severe mental state than those in the control group. The control group are older and more psychopathologically stable patients. So already from the initial moment of the study they are two populations with different characteristics.

Main Objective:

To determine the effectiveness of the use of a sensory comfort room in the functional rehabilitation area 1 of the HPA. It would be considered effective if mechanical restraints decrease by 5% in the intervention group with respect to the previous year.

Primary Outcome Measures: Number of mechanical restraints, Mechanical restraint is understood as the extreme therapeutic intervention, through the application of immobilizing restrictive devices to limit a patient's freedom and, in turn, allows us to ensure their own safety and/or that of other, Up to 24 months
Secondary Outcome Measures: Change in the agitation level, Agitation Score in Positive and Negative Symptoms Scale, Excitement Component (PEC) It is a scale with five items: Tension; Uncooperativeness; Hostility; Poor impulse control; and Excitement. Each of these items is rated with the following scores: 1. Absent. 2. Minimal. 3. Mild. 4. Moderate. Moderately severe. 6. Severe. 7. Extreme.

A higher score on the PEC scale indicates greater agitation. The classification of the level of agitation is as follows: Questionable (5-10 points), mild (11-15 points) Moderate (16-20 points) Moderately severe (20-25 points) Severe (26-30 points or Item "impulse control" \> 4) Extremely severe (30-35 points).

Whether or not the score on the PEC scale is lower before using the room and afterwards will be evaluated (15). It is considered that there is a decrease in the PEC scale if it is lower by one point. Before room use and afterwards., Through study completion, an average of 2 years|Number of isolations, Defined as the supervised confinement of a patient in a locked room alone for a period of time to protect the patient, or staff, from serious harm, Up to 24 months|Number of patients who need Rescue medication, Rescue medication to overcome the crisis, Up to 24 months
Other Outcome Measures: Patients satisfaction questionnaire with confort room, Satisfaction and Proposals for room improvement, completed after each use, Through study completion, an average of 2 years|Professionals satisfaction questionaire with confort room, About their experience with the employment of room, completed after each use, Through study completion, an average of 2 years|Age, Numerical variable, At baseline|Sex, Male, famale, At baseline|Cognitive level with mini-mental scale., This is the most widely used brief cognitive test in Spain. It is mainly used to detect cognitive disorders associated with neurodegenerative diseases such as Alzheimer's disease. There are 2 versions of 30 and 35 points. The test has 5 items (orientation, fixation, concentration and calculation, memory, language and construction). Impairment is considered to be present when the score is less than 23 points, At baseline|Age of mental disease evolution, Numerical variable, At baseline|Diagnosis, According to the International Classification of Diseases, At baseline