Effect of Music on Patients in Intensive Care Units (MTS2)
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| First Received Date ICMJE | January 14, 2009 | ||||||||
| Last Updated Date | July 22, 2010 | ||||||||
| Start Date ICMJE | July 2006 | ||||||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00823017 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Psychophysical properties of relaxation music [ Time Frame: 1 rating ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Music on Patients in Intensive Care Units | ||||||||
| Official Title ICMJE | The Effect of Patient-Preferred Music, Relaxation Music, and Standard Care Environment on Patients in Intensive Care Units | ||||||||
| Brief Summary | The purpose of this study is to investigate the effects of patient-preferred music, relaxation music, and standard care environment on patients in intensive care units. |
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| Detailed Description | This study is a prospective randomized clinical trial. The purpose of this 4-stage study is to explore the effects of patient-preferred music, relaxation music, and standard care environment on patients in intensive care units. Stage 1: Recommendation of relaxation music by music therapists who serves as expert panel Stage 2: Analysis of recommended relaxation music by music therapists Stage 3: Content validation of relaxation music by healthy adults Stage 4: Comparison of patients' physiological, psychological, and biological responses to patient-preferred music, relaxation music, and standard care environment |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Intensive Care Unit | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Completion Date | July 2010 | ||||||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Communicative (non-intubated, non-sedated)
Non-communicative (intubated, sedated)
Exclusion Criteria: Communicative (non-intubated, non-sedated)
Non-communicative (intubated, sedated)
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00823017 | ||||||||
| Other Study ID Numbers ICMJE | 06-00070 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Xueli Tan, MM, MT-BC, The Cleveland Music School Settlement | ||||||||
| Study Sponsor ICMJE | MetroHealth Medical Center | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | MetroHealth Medical Center | ||||||||
| Verification Date | July 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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