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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00823017
First Posted: January 15, 2009
Last Update Posted: July 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Cleveland Music School Settlement
Kulas Foundation
Arthur Flagler Fultz Research Award (American Music Therapy Association)
Information provided by:
MetroHealth Medical Center
  Purpose
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 Intervention Phase
Intensive Care Unit Other: Patient-preferred music Other: Relaxation Music Other: Standard Care Environment Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by MetroHealth Medical Center:

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

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

Estimated Enrollment: 40
Study Start Date: July 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: 3
Standard Care Environment
Other: Standard Care Environment
Control, no interventions

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Responsible Party: Xueli Tan, MM, MT-BC, The Cleveland Music School Settlement
ClinicalTrials.gov Identifier: NCT00823017     History of Changes
Other Study ID Numbers: 06-00070
First Submitted: January 14, 2009
First Posted: January 15, 2009
Last Update Posted: July 23, 2010
Last Verified: July 2010

Keywords provided by MetroHealth Medical Center:
ICU environment
Auditory stimulation
Properties of relaxation music
music
music therapy
pain
anxiety
cortisol
IgA
biomarkers
relaxation music