Efficacy of a Sensory Comfort Room in Agitation Control

NCT06547671 | Completed

• 1 other identifier: AGITCONF2024
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorders, Severe

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in the agitation level

  Through study completion, an average of 2 years

• Number of isolations

  Up to 24 months

• Number of patients who need Rescue medication

  Up to 24 months

Other Outcomes (7)

• Patients satisfaction questionnaire with confort room

  Through study completion, an average of 2 years

• Professionals satisfaction questionaire with confort room

  Through study completion, an average of 2 years

• Age

  At baseline

Study Arms (2)

Comfort room

EXPERIMENTAL

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.

Usual clinical practice

NO INTERVENTION

Follow up of patients, in the same way as in routine clinical practice.

Interventions

Employment of a confort room to help in anxiety and agitation moments. OTHER

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.

Comfort room

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioaraba Health Research Institute: lead

Study Sites (1)

Araba University Hospital

Vitoria-Gasteiz, Alava, Spain

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• MARIA OLÁRIZU OLALDE

  Basque Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse in Araba University Hospital

Model Details: Not randomized clinical trial in parallel groups

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: August 9, 2024
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

ES (1)