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Clinical Trials/NCT00823017
NCT00823017
Withdrawn
Phase 1

The Effect of Patient-Preferred Music, Relaxation Music, and Standard Care Environment on Patients in Intensive Care Units

MetroHealth Medical Center1 site in 1 countryJuly 2006

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Intensive Care Unit
Sponsor
MetroHealth Medical Center
Locations
1
Primary Endpoint
Pain level
Status
Withdrawn
Last Updated
7 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
March 2, 2011
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Charles J. Yowler MD

Professor, Case Western Reserve University School of Medicine

MetroHealth Medical Center

Eligibility 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

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

Outcomes

Primary Outcomes

Pain level

Time Frame: 4 data points throughout 1-hour intervention

Anxiety level

Time Frame: 4 data points throughout 1-hour intervention

Respiration rate

Time Frame: 4 data points throughout 1-hour intervention

Comfort level

Time Frame: 4 data points throughout 1-hour intervention

Saliva/Serum Immunoglobulin A Concentration

Time Frame: 3 data points throughout 1-hour intervention

Heart 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

Secondary Outcomes

  • Psychophysical properties of relaxation music(1 rating)

Study Sites (1)

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