Effect of Music on Patients in Intensive Care Units - Full Text View

Sponsors and Collaborators:	MetroHealth Medical Center The Cleveland Music School Settlement Kulas Foundation Arthur Flagler Fultz Research Award (American Music Therapy Association)
Information provided by:	MetroHealth Medical Center
ClinicalTrials.gov Identifier:	NCT00823017

Purpose

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.

Condition	Intervention	Phase
Intensive Care Unit	Other: Patient-preferred music Other: Relaxation Music Other: Standard Care Environment	Phase I

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Crossover Assignment, Efficacy Study
Official Title:	The Effect of Patient-Preferred Music, Relaxation Music, and Standard Care Environment on Patients in Intensive Care Units

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:

Pain level [ Time Frame: 4 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
Anxiety level [ Time Frame: 4 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
Comfort level [ Time Frame: 4 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
Heart rate [ Time Frame: 4 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
Respiration rate [ Time Frame: 4 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: 4 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
Saliva/Serum Cortisol level [ Time Frame: 3 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]
Saliva/Serum Immunoglobulin A Concentration [ Time Frame: 3 data points throughout 1-hour intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Psychophysical properties of relaxation music [ Time Frame: 1 rating ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patient-preferred music	Other: Patient-preferred music Music of patients' preference
2: Experimental Relaxation Music	Other: Relaxation Music Relaxation music compiled from results of first three stages of study
3: No Intervention Standard Care Environment	Other: Standard Care Environment Control, no interventions

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823017

Contacts

Contact: Xueli Tan, MM, MT-BC	(216) 778-4683	xtan@metrohealth.org
Contact: Charles Yowler, MD, FACS	(216) 778-5627	cyowler@metrohealth.org

Locations

United States, Ohio
MetroHealth Medical Center	Recruiting
Cleveland, Ohio, United States, 44109
Contact: Xueli Tan, MM, MT-BC 216-778-4683 xtan@metrohealth.org
Contact: Charles J Yowler, MD, FACS (216) 778-5627 cyowler@metrohealth.org
Sub-Investigator: Xueli Tan, MM, MT-BC
Sub-Investigator: Charles J Yowler, MD, FACS
Principal Investigator: Richard B Fratianne, MD, FACS
Sub-Investigator: Dennis M Super, MD, MPH

Sponsors and Collaborators

MetroHealth Medical Center

The Cleveland Music School Settlement

Kulas Foundation

Arthur Flagler Fultz Research Award (American Music Therapy Association)

Investigators

Study Chair:	Xueli Tan, MM, MT-BC	The Cleveland Music School Settlement
Principal Investigator:	Richard B Fratianne, MD, FACS	MetroHealth Medical Center

More Information

No publications provided

Responsible Party:	The Cleveland Music School Settlement ( Xueli Tan, MM, MT-BC )
Study ID Numbers:	06-00070
Study First Received:	January 14, 2009
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00823017 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:

ICU environment
Auditory stimulation
Properties of relaxation music
music
music therapy
pain

anxiety
icu environment
cortisol
IgA
biomarkers
relaxation music

Study placed in the following topic categories:

Hydrocortisone
Cortisol succinate
Pain
Hydrocortisone acetate

ClinicalTrials.gov processed this record on September 01, 2009