Clinical trial NCT00823017: Effect of Music on Patients in Intensive Care Units
Official title: The Effect of Patient-Preferred Music, Relaxation Music, and Standard Care Environment on Patients in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Intensive Care Unit
Keywords: ICU environment
Auditory stimulation
Properties of relaxation music
music
music therapy
pain
anxiety
cortisol
IgA
biomarkers
relaxation music
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Music School Settlement
name: Kulas Foundation
name: Arthur Flagler Fultz Research Award (American Music Therapy Association)
First posted: 2009-01-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

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

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

Primary outcomes:
measure: Pain level
timeFrame: 4 data points throughout 1-hour intervention
measure: Anxiety level
timeFrame: 4 data points throughout 1-hour intervention
measure: Comfort level
timeFrame: 4 data points throughout 1-hour intervention
measure: Heart rate
timeFrame: 4 data points throughout 1-hour intervention
measure: Respiration rate
timeFrame: 4 data points throughout 1-hour intervention
measure: Blood pressure
timeFrame: 4 data points throughout 1-hour intervention
measure: Saliva/Serum Cortisol level
timeFrame: 3 data points throughout 1-hour intervention
measure: Saliva/Serum Immunoglobulin A Concentration
timeFrame: 3 data points throughout 1-hour intervention
Secondary outcomes:
measure: Psychophysical properties of relaxation music
timeFrame: 1 rating
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: The Cleveland Music School Settlement
name: Xueli Tan, MM, MT-BC
role: STUDY_CHAIR
affiliation: MetroHealth Medical Center
name: Richard B Fratianne, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: