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| Sponsored by: |
Griffin Hospital |
| Information provided by: | Griffin Hospital |
| ClinicalTrials.gov Identifier: | NCT00409370 |
Purpose
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 |
|
Delirium Agitated Behavior Alcohol Withdrawl Acute Confusional State Acute Psychosis |
Device: SOMA safe enclosure |
Phase III |
| MedlinePlus related topics: | Psychotic Disorders |
| 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 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | 2002-25 |
| First Received: | December 7, 2006 |
| Last Updated: | December 7, 2006 |
| ClinicalTrials.gov Identifier: | NCT00409370 |
| Health Authority: | United States: Institutional Review Board |
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