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| Descriptive Information Fields | |||||
| Brief Title † | Music Therapy for Patients Being Weaned From Mechanical Ventilation | ||||
| Official Title † | Music Therapy as an Adjunctive Treatment in the Management of Stress for Patients Being Weaned From Mechanical Ventilation | ||||
| Brief Summary | The purpose of the study is to determine whether Music Therapy interventions can be used as supportive therapy for patients undergoing weaning from mechanical ventilation. The music will support the procedure by serving as a stimulus for relaxation and/or pain and anxiety management.Music used is varied according to subject's preferences. |
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| Detailed Description | Music therapy interventions will be used as supportive therapy for patients undergoing weaning from mechanical ventilation. The music will support the procedure by serving as a stimulus for relaxation and/or pain and anxiety management. The intervention will consist of 40 - 50 minutes of active music therapy and improvisation in which the music is used as a distraction from the hospital setting and the procedure taking place. The intervention will end with 5 to 10 minutes of discussion of music activities/selections to be used between music therapy sessions. The intervention is individualized and can be modified accordingly to the subject's preferences. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Evaluate the efficacy of music therapy interventions in assisting patient to be liberated from mechanical ventilation more quickly than control subjects. [ Time Frame: prospective ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Exploratory hypotheses will investigate decreased anxiety measured by -physiologic measures [ Time Frame: prospective ] [ Designated as safety issue: No ] - decreased use of anxiolytic, antidepressant and antipsychotic agents. [ Time Frame: prospective ] [ Designated as safety issue: No ] |
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| Condition † | Respiratory Insufficiency | ||||
| Intervention † | Behavioral: Music Therapy | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 40 | ||||
| Start Date † | April 2004 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria: weaning trials greater than 8 hours - |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00178139 | ||||
| Organization ID | 10243 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University of Rochester | ||||
| Collaborators †† | Arthur Flager Fultz Research Fund | ||||
| Investigators † |
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| Information Provided By | University of Rochester | ||||
| Verification Date | September 2005 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | July 11, 2008 | ||||
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