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

MetroHealth Medical Center

Status and phase: Withdrawn; Phase 1

Conditions: Intensive Care Unit

Treatments: Other: Patient-preferred music; Other: Relaxation Music; Other: Standard Care Environment

Study type: Interventional

Funder types: Other

Identifiers

NCT00823017

IRB06-00070

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Patient-preferred music

Treatment:

Other: Patient-preferred music

2

Experimental group

Description:

Relaxation Music

Treatment:

Other: Relaxation Music

3

Placebo Comparator group

Description:

Standard of Care

Treatment:

Other: Standard Care Environment