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Effect of Music on Patients in Intensive Care Units (MTS2)

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ClinicalTrials.gov Identifier: NCT00823017
Recruitment Status : Withdrawn (study withdrawn from IRB)
First Posted : January 15, 2009
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
The Cleveland Music School Settlement
Kulas Foundation
Arthur Flagler Fultz Research Award (American Music Therapy Association)
Information provided by (Responsible Party):
Charles J. Yowler MD, MetroHealth Medical Center

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.

Condition or disease Intervention/treatment Phase
Intensive Care Unit Other: Patient-preferred music Other: Relaxation Music Other: Standard Care Environment Phase 1

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Patient-Preferred Music, Relaxation Music, and Standard Care Environment on Patients in Intensive Care Units
Study Start Date : July 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : March 2, 2011

Arm Intervention/treatment
Experimental: 1
Patient-preferred music
Other: Patient-preferred music
Music of patients' preference

Experimental: 2
Relaxation Music
Other: Relaxation Music
Relaxation music compiled from results of first three stages of study

Placebo Comparator: 3
Standard of Care
Other: Standard Care Environment
Control, no interventions




Primary Outcome Measures :
  1. Pain level [ Time Frame: 4 data points throughout 1-hour intervention ]
  2. Anxiety level [ Time Frame: 4 data points throughout 1-hour intervention ]
  3. Comfort level [ Time Frame: 4 data points throughout 1-hour intervention ]
  4. Heart rate [ Time Frame: 4 data points throughout 1-hour intervention ]
  5. Respiration rate [ Time Frame: 4 data points throughout 1-hour intervention ]
  6. Blood pressure [ Time Frame: 4 data points throughout 1-hour intervention ]
  7. Saliva/Serum Cortisol level [ Time Frame: 3 data points throughout 1-hour intervention ]
  8. Saliva/Serum Immunoglobulin A Concentration [ Time Frame: 3 data points throughout 1-hour intervention ]

Secondary Outcome Measures :
  1. Psychophysical properties of relaxation music [ Time Frame: 1 rating ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Communicative (non-intubated, non-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 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:

Communicative (non-intubated, non-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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823017


Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
The Cleveland Music School Settlement
Kulas Foundation
Arthur Flagler Fultz Research Award (American Music Therapy Association)
Investigators
Study Chair: Xueli Tan, MM, MT-BC The Cleveland Music School Settlement
Principal Investigator: Richard B Fratianne, MD, FACS MetroHealth Medical Center

Responsible Party: Charles J. Yowler MD, Professor, Case Western Reserve University School of Medicine, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00823017     History of Changes
Other Study ID Numbers: IRB06-00070
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Keywords provided by Charles J. Yowler MD, MetroHealth Medical Center:
ICU environment
Auditory stimulation
Properties of relaxation music
music
music therapy
pain
anxiety
cortisol
IgA
biomarkers
relaxation music