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Sponsored by: |
Griffin Hospital |
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Information provided by: | Griffin Hospital |
ClinicalTrials.gov Identifier: | NCT00409370 |
This study compared standard hospital restraints to a newer safety net restraint system to compare them for acceptability, tolerance, duration of restrain, length of stay in the hospital, and satisfaction of MD, nurse, and relatives of patients.
Condition | Intervention | Phase |
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Delirium Agitated Behavior Alcohol Withdrawl Acute Confusional State Acute Psychosis |
Device: SOMA safe enclosure |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Clinical Trial to Compare The Use Of Safety Net Enclosures With Standard Restraints in Agitated Hospitalized Patients |
Estimated Enrollment: | 60 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | February 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2002-25 |
Study First Received: | December 7, 2006 |
Last Updated: | December 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00409370 History of Changes |
Health Authority: | United States: Institutional Review Board |
Psychomotor Agitation Confusion Dyskinesias Cognition Disorders Schizophrenia Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Neurologic Manifestations Psychotic Disorders Dementia Neurobehavioral Manifestations Schizophrenia and Disorders with Psychotic Features Delirium |
Nervous System Diseases Confusion Psychomotor Agitation Dyskinesias Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Psychomotor Disorders Neurologic Manifestations Psychotic Disorders Neurobehavioral Manifestations Schizophrenia and Disorders with Psychotic Features Delirium |