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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Psychophysical properties of relaxation music [ Time Frame: 1 rating ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 14, 2009
Last Updated: July 22, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013