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Completed

NCT Number: NCT06547671

Efficacy of a Sensory Comfort Room in Agitation Control

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.

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Key information

Conditions

Mental Disorders, Severe Mental Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Araba University Hospital

Vitoria-Gasteiz, Alava, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of mechanical restraints

    Time frame: Up to 24 months

    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

Secondary outcomes

  1. Change in the agitation level

    Time frame: Through study completion, an average of 2 years

    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.

  2. Number of isolations

    Time frame: Up to 24 months

    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

  3. Number of patients who need Rescue medication

    Time frame: Up to 24 months

    Rescue medication to overcome the crisis

Other outcomes

  1. Patients satisfaction questionnaire with confort room

    Time frame: Through study completion, an average of 2 years

    Satisfaction and Proposals for room improvement, completed after each use

  2. Professionals satisfaction questionaire with confort room

    Time frame: Through study completion, an average of 2 years

    About their experience with the employment of room, completed after each use

  3. Age

    Time frame: At baseline

    Numerical variable

  4. Sex

    Time frame: At baseline

    Male, famale

  5. Cognitive level with mini-mental scale.

    Time frame: At baseline

    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

  6. Age of mental disease evolution

    Time frame: At baseline

    Numerical variable

  7. Diagnosis

    Time frame: At baseline

    According to the International Classification of Diseases

Sponsors and collaborators

Lead sponsor

Bioaraba Health Research Institute

Network

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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