Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547671
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Efficacy of a Sensory Comfort Room in Agitation Control
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Effectiveness of a Comfort-sensory Room in the Control of Agitation in a Functional Mental Health Rehabilitation Area
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None