Effect of Music on Patients in Intensive Care Units

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Intensive Care Unit

Intervention / Treatment
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* Other: Patient-preferred music
* Other: Relaxation Music
* Other: Standard Care Environment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patient-preferred music | Other: Patient-preferred music<br>* Music of patients' preference<br>|
| Experimental: 2<br>Relaxation Music | Other: Relaxation Music<br>* Relaxation music compiled from results of first three stages of study<br>|
| Placebo Comparator: 3<br>Standard of Care | Other: Standard Care Environment<br>* Control, no interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Saliva/Serum Immunoglobulin A Concentration |  | 3 data points throughout 1-hour intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychophysical properties of relaxation music |  | 1 rating | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU environment, Auditory stimulation, Properties of relaxation music, music, music therapy, pain, anxiety, cortisol, IgA, biomarkers, relaxation music