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

This study has been completed.
Sponsor:
Collaborators:
The Cleveland Music School Settlement
Kulas Foundation
Arthur Flagler Fultz Research Award (American Music Therapy Association)
Information provided by:
MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00823017
First received: January 14, 2009
Last updated: July 22, 2010
Last verified: July 2010

January 14, 2009
July 22, 2010
July 2006
July 2010   (final data collection date for primary outcome measure)
  • Pain level [ Time Frame: 4 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
  • Anxiety level [ Time Frame: 4 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
  • Comfort level [ Time Frame: 4 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
  • Heart rate [ Time Frame: 4 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
  • Respiration rate [ Time Frame: 4 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 4 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
  • Saliva/Serum Cortisol level [ Time Frame: 3 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
  • Saliva/Serum Immunoglobulin A Concentration [ Time Frame: 3 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00823017 on ClinicalTrials.gov Archive Site
Psychophysical properties of relaxation music [ Time Frame: 1 rating ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Music on Patients in Intensive Care Units
The Effect of Patient-Preferred Music, Relaxation Music, and Standard Care Environment on Patients in Intensive Care Units

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Intensive Care Unit
  • Other: Patient-preferred music
    Music of patients' preference
  • Other: Relaxation Music
    Relaxation music compiled from results of first three stages of study
  • Other: Standard Care Environment
    Control, no interventions
  • Experimental: 1
    Patient-preferred music
    Intervention: Other: Patient-preferred music
  • Experimental: 2
    Relaxation Music
    Intervention: Other: Relaxation Music
  • No Intervention: 3
    Standard Care Environment
    Intervention: Other: Standard Care Environment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00823017
06-00070
No
Xueli Tan, MM, MT-BC, The Cleveland Music School Settlement
MetroHealth Medical Center
  • The Cleveland Music School Settlement
  • Kulas Foundation
  • Arthur Flagler Fultz Research Award (American Music Therapy Association)
Study Chair: Xueli Tan, MM, MT-BC The Cleveland Music School Settlement
Principal Investigator: Richard B Fratianne, MD, FACS MetroHealth Medical Center
MetroHealth Medical Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP