Efficacy of a Sensory Comfort Room in Agitation Control

Evaluation of the Effectiveness of a Comfort-sensory Room in the Control of Agitation in a Functional Mental Health Rehabilitation Area

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorders, Severe
• Intervention / Treatment: Other: Employment of a confort room to help in anxiety and agitation moments.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alava
    • Vitoria-gasteiz, Alava, Spain
      • Araba University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comfort room; Use of the sensory comfort room located in the unit itself, decorated in soft and relaxing tones with motifs inspired by nature. It has relaxation sofas, rocking chair, aromatherapy, chromotherapy, projector, music of the user's choice, weighted blanket mats, balls of various sizes......... to teach people admitted to the area alternatives to cope and control anxiety and prevent the escalation of agitation, as well as to guide them in strategies to help them relax. In addition, as usual clinical practice, both before and after the intervention, verbal de-escalation techniques will be used, for which the professionals in the area have been trained with a verbal de-escalation course specifically for working in the area. The intervention is not unique but in several uses of the sensory comfort room in each patient. The intervention will last approximately 30 minutes and can be used several times during the day. Furthermore, patients received the same follow up than the control group.	Other: Employment of a confort room to help in anxiety and agitation moments.; Use of the sensory comfort room located in the unit itself, decorated in soft and relaxing tones with motifs inspired by nature. It has relaxation sofas, rocking chair, aromatherapy, chromotherapy, projector, music of the user's choice, weighted blanket mats, balls of various sizes......... to teach people admitted to the area alternatives to cope and control anxiety and prevent the escalation of agitation, as well as to guide them in strategies to help them relax.
No Intervention: Usual clinical practice; Follow up of patients, in the same way as in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bioaraba Health Research Institute
• Investigators: Principal Investigator: MARIA OLÁRIZU OLALDE, Basque Health Service

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: AGITCONF2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No