Effect of Music on Patients in Intensive Care Units | NCT00823017

Studies
Effect of Music on Patients in Intensive Care Units

NCT00823017

Sponsor

MetroHealth Medical Center

Status

Withdrawn

Last Update Posted

May 18, 2018Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Intensive Care Unit

Interventions

Patient-preferred music
Relaxation Music
Standard Care Environment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study withdrawn from IRB

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Jul 2010Actual

Completion Date

Mar 2, 2011Actual

First Submitted Date

Jan 14, 2009

First Submission Date that Met QC Criteria

Jan 14, 2009

First Posted Date

Jan 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2018

Last Update Posted Date

May 18, 2018Actual

Name	Class
The Cleveland Music School Settlement	OTHER
Kulas Foundation	OTHER
Arthur Flagler Fultz Research Award (American Music Therapy Association)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Patient-preferred music	Other: Patient-preferred music
2	Experimental	Relaxation Music	Other: Relaxation Music
3	Placebo Comparator	Standard of Care	Other: Standard Care Environment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient-preferred music	Other	Music of patients' preference	1
Relaxation Music

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
Psychophysical properties of relaxation music		1 rating

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

ID	Term
D010146	Pain
D001008	Anxiety Disorders

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders