Effect of Music on Patients in Intensive Care Units (MTS2)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Intensive Care Unit
• Intervention / Treatment: Other: Patient-preferred music; Other: Relaxation Music; Other: Standard Care Environment

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

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Psychophysical properties of relaxation music	1 rating

Collaborators and Investigators

• Sponsor: MetroHealth Medical Center
• Collaborators: The Cleveland Music School Settlement; Kulas Foundation; Arthur Flagler Fultz Research Award (American Music Therapy Association)
• Investigators: Principal Investigator: Richard B Fratianne, MD, FACS, MetroHealth Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): March 2, 2011

Study Registration Dates

• First Submitted: January 14, 2009
• First Submitted That Met QC Criteria: January 14, 2009
• First Posted (Estimate): January 15, 2009

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: pain; biomarkers; anxiety; music; music therapy; cortisol; Auditory stimulation; IgA; ICU environment; Properties of relaxation music; relaxation music
• Other Study ID Numbers: IRB06-00070