Efficacy of a Sensory Comfort Room in Agitation Control

NCT ID: NCT06547671

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-05-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Usual clinical practice

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioaraba Health Research Institute

NETWORK

Sponsor Role: lead

Responsible Party

Maria Olárizu Olalde Ortiz

Nurse in Araba University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MARIA OLÁRIZU OLALDE

Role: PRINCIPAL_INVESTIGATOR

Basque Health Service

Locations

Araba University Hospital

Vitoria-Gasteiz, Alava, Spain

Countries

Spain

Other Identifiers

AGITCONF2024

Identifier Type: -

Identifier Source: org_study_id