Effect of Music on Patients in Intensive Care Units
- Conditions
- Intensive Care Unit
- Interventions
- Other: Relaxation MusicOther: Patient-preferred musicOther: Standard Care Environment
- Registration Number
- NCT00823017
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 Relaxation Music Relaxation Music 1 Patient-preferred music Patient-preferred music 3 Standard Care Environment Standard of Care
- Primary Outcome Measures
Name Time Method Pain level 4 data points throughout 1-hour intervention Anxiety level 4 data points throughout 1-hour intervention Respiration rate 4 data points throughout 1-hour intervention Comfort level 4 data points throughout 1-hour intervention Saliva/Serum Immunoglobulin A Concentration 3 data points throughout 1-hour intervention Heart rate 4 data points throughout 1-hour intervention Blood pressure 4 data points throughout 1-hour intervention Saliva/Serum Cortisol level 3 data points throughout 1-hour intervention
- Secondary Outcome Measures
Name Time Method Psychophysical properties of relaxation music 1 rating
Trial Locations
- Locations (1)
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States