Intensive Care Unit
Conditions
Keywords
ICU environment, Auditory stimulation, Properties of relaxation music, music, music therapy, pain, anxiety, cortisol, IgA, biomarkers, relaxation music
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
Interventions
OTHERPatient-preferred music
Music of patients' preference
OTHERRelaxation Music
Relaxation music compiled from results of first three stages of study
OTHERStandard Care Environment
Control, no interventions
Sponsors
The Cleveland Music School Settlement
Kulas Foundation
Arthur Flagler Fultz Research Award (American Music Therapy Association)
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Saliva/Serum Immunoglobulin A Concentration | 3 data points throughout 1-hour intervention |
| Pain level | 4 data points throughout 1-hour intervention |
| Anxiety level | 4 data points throughout 1-hour intervention |
| Comfort level | 4 data points throughout 1-hour intervention |
| Heart rate | 4 data points throughout 1-hour intervention |
| Respiration 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
| Measure | Time frame |
|---|---|
| Psychophysical properties of relaxation music | 1 rating |
Countries
United States
Outcome results
None listed