Mental Disorders, SevereNCT06547671
Efficacy of a Sensory Comfort Room in Agitation Control
A study testing Employment of a confort room to help in anxiety and agitation moments. in people with Mental Disorders, Severe, run by Bioaraba Health Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Disorders, Severe
- What is being tested?
- Employment of a confort room to help in anxiety and agitation moments.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mental Disorders, Severe
- Being tested
- Employment of a confort room to help in anxiety and agitation moments.
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 24 months
Secondary outcomes (3)
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.
Measured: 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
Measured: Up to 24 months
Number of patients who need Rescue medication
Rescue medication to overcome the crisis
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 May 2021
- Primary completion1 May 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Disorders, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Not randomized clinical trial in parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioaraba Health Research Institute
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Maria Olárizu Olalde Ortiz, Bioaraba Health Research Institute
- Investigators
- MARIA OLÁRIZU OLALDE, Principal investigator, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547671
- Sponsor's protocol ID
- AGITCONF2024
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Comfort-sensory Room in the Control of Agitation in a Functional Mental Health Rehabilitation Area
- ClinicalTrials.gov ID
- NCT06547671
- Acronym / sponsor ID
- AGITCONF2024
- Conditions
- Mental Disorders, Severe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Bioaraba Health Research InstituteResearch network
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Not randomized clinical trial in parallel groups
| Arm | Type | Receives |
|---|---|---|
| Comfort room | Experimental | 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. 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. |
| Usual clinical practice | No intervention | –Follow up of patients, in the same way as in routine clinical practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Comfort room |
Primary outcome
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
3 secondary outcomes
Change in the agitation level
Time frame: Through study completion, an average of 2 years
Number of isolations
Time frame: Up to 24 months
Number of patients who need Rescue medication
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARIA OLÁRIZU OLALDE principal investigator
Basque Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Employment of a confort room to help in anxiety and agitation moments. in people with Mental Disorders, Severe, run by Bioaraba Health Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of mechanical restraints (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.