Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2006-07-31
2011-03-02
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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1
Patient-preferred music
Patient-preferred music
Music of patients' preference
2
Relaxation Music
Relaxation Music
Relaxation music compiled from results of first three stages of study
3
Standard of Care
Standard Care Environment
Control, no interventions
Interventions
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Patient-preferred music
Music of patients' preference
Relaxation Music
Relaxation music compiled from results of first three stages of study
Standard Care Environment
Control, no interventions
Eligibility Criteria
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Inclusion Criteria
* At least three days of admission (excluding day of admission)
* 18 years or older
* Mean arterial blood pressure equal or greater than 65 throughout study
* Mean SpO2 equal or greater than 90 throughout study
* Glasgow coma scale equal or greater than 14
* Bilirubin level less than 5
* Ammonia level less than 1
* Hematocrit level greater than 15
* BUN equal or less than 100
Non-communicative (intubated, sedated)
* At least three days of admission (excluding day of admission)
* 18 years or older
* Mean arterial blood pressure equal or greater than 65 throughout study
* Mean SpO2 equal or greater than 90 throughout study
* Glasgow coma scale equal or greater than 10
* Bilirubin level less than 5
* Ammonia level less than 1
* Hematocrit level greater than 15
* BUN equal or less than 100
Exclusion Criteria
* Patients admitted for or less than 3 days
* Patients with hearing impairments
* Patients with neurological impairments that might impair their ability to process information
* Patients on glucocorticoid medications
* Patients with mental health diagnoses and currently experiencing active psychosis such as hallucinations and/or delusions
* Patient's condition altered dramatically over the 3 days of research
Non-communicative (intubated, sedated)
* Patients admitted for or less than 3 days
* Patients with hearing impairments
* Patients with neurological impairments that might impair their ability to process information
* Patients on glucocorticoid medications
* Patients with mental health diagnoses and currently experiencing active psychosis such as hallucinations and/or delusions
* Patient's condition altered dramatically over the 3 days of research
18 Years
ALL
No
Sponsors
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The Cleveland Music School Settlement
OTHER
Kulas Foundation
OTHER
Arthur Flagler Fultz Research Award (American Music Therapy Association)
UNKNOWN
MetroHealth Medical Center
OTHER
Responsible Party
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Charles J. Yowler MD
Professor, Case Western Reserve University School of Medicine
Principal Investigators
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Xueli Tan, MM, MT-BC
Role: STUDY_CHAIR
The Cleveland Music School Settlement
Richard B Fratianne, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
Locations
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MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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IRB06-00070
Identifier Type: -
Identifier Source: org_study_id
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