Effect of Music on Patients in Intensive Care Units

Intensive Care Unit Clinical Trial

— MTS2  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00823017
• Other study ID #: IRB06-00070
• Status: Withdrawn
• Phase: Phase 1
• Start date: July 2006
• Est. completion date: March 2, 2011

Study information

• Verified date: May 2018
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2, 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit

Intervention

Other:
• Patient-preferred music
Music of patients' preference
• Relaxation Music
Relaxation music compiled from results of first three stages of study
• Standard Care Environment
Control, no interventions

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
MetroHealth Medical Center	Arthur Flagler Fultz Research Award (American Music Therapy Association), Kulas Foundation, The Cleveland Music School Settlement

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level		4 data points throughout 1-hour intervention
Primary	Anxiety level		4 data points throughout 1-hour intervention
Primary	Comfort level		4 data points throughout 1-hour intervention
Primary	Heart rate		4 data points throughout 1-hour intervention
Primary	Respiration rate		4 data points throughout 1-hour intervention
Primary	Blood pressure		4 data points throughout 1-hour intervention
Primary	Saliva/Serum Cortisol level		3 data points throughout 1-hour intervention
Primary	Saliva/Serum Immunoglobulin A Concentration		3 data points throughout 1-hour intervention
Secondary	Psychophysical properties of relaxation music		1 rating