The Effect of Patient-Preferred Music, Relaxation Music, and Standard Care Environment on Patients in Intensive Care Units
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- MetroHealth Medical Center
- Locations
- 2
- Primary Endpoint
- Pain level
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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)
Investigators
Charles J. Yowler MD
Professor, Case Western Reserve University School of Medicine
MetroHealth Medical Center