Clinical trial NCT06547671: Efficacy of a Sensory Comfort Room in Agitation Control
Official title: Evaluation of the Effectiveness of a Comfort-sensory Room in the Control of Agitation in a Functional Mental Health Rehabilitation Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders, Severe
Lead sponsor: Bioaraba Health Research Institute
Sponsor class: NETWORK
First posted: 2024-08-09
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Not randomized clinical trial in parallel groups
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to functional rehabilitation area 1 presenting with questionable, mild or moderate Agitation (score less than or equal to 20 on the PEC scale) or at the patient's request.
* To have freely accepted to participate in the intervention and to have signed the informed consent. An information sheet will also be given to the patient and an information sheet to the tutor (APPENDIXES 1 and 2). Experts in easy reading are consulted to adapt this document.

Exclusion criteria:

* Severe and extremely severe agitation (score greater than or equal to 21 on the PEC scale). Immediate previous physical aggression.
* Declination of the signature of informed consent.
* Any participant who does not comply with the rules of use of the room will be excluded from the study.

Primary outcomes:
measure: Number of mechanical restraints
timeFrame: Up to 24 months
Secondary outcomes:
measure: Change in the agitation level
timeFrame: Through study completion, an average of 2 years
measure: Number of isolations
timeFrame: Up to 24 months
measure: Number of patients who need Rescue medication
timeFrame: Up to 24 months
Other outcomes:
measure: Patients satisfaction questionnaire with confort room
timeFrame: Through study completion, an average of 2 years
measure: Professionals satisfaction questionaire with confort room
timeFrame: Through study completion, an average of 2 years
measure: Age
timeFrame: At baseline
measure: Sex
timeFrame: At baseline
measure: Cognitive level with mini-mental scale.
timeFrame: At baseline
measure: Age of mental disease evolution
timeFrame: At baseline
measure: Diagnosis
timeFrame: At baseline
Locations:
city: Vitoria-gasteiz
country: Spain
facility: Araba University Hospital
state: Alava
Study officials:
affiliation: Basque Health Service
name: MARIA OLÁRIZU OLALDE
role: PRINCIPAL_INVESTIGATOR
References: