NCT00823017

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2011

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

4 years

First QC Date

January 14, 2009

Last Update Submit

May 16, 2018

Conditions

Intensive Care Unit

Keywords

ICU environmentAuditory stimulationProperties of relaxation musicmusicmusic therapypainanxietycortisolIgAbiomarkersrelaxation music

Outcome Measures

Primary Outcomes (8)

  • 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 (1)

  • Psychophysical properties of relaxation music

    1 rating

Study Arms (3)

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

Patient-preferred musicOTHER

Music of patients' preference

1
Relaxation MusicOTHER

Relaxation music compiled from results of first three stages of study

2
Standard Care EnvironmentOTHER

Control, no interventions

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Communicative (non-intubated, non-sedated)
  • At least three days of admission (excluding day of admission)
  • 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)
  • years or older
  • Mean arterial blood pressure equal or greater than 65 throughout study
  • Mean SpO2 equal or greater than 90 throughout study
  • +5 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Xueli Tan, MM, MT-BC

    The Cleveland Music School Settlement

    STUDY CHAIR

  • Richard B Fratianne, MD, FACS

    MetroHealth Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Case Western Reserve University School of Medicine

Study Record Dates

First Submitted

January 14, 2009

First Posted

January 15, 2009

Study Start

July 1, 2006

Primary Completion

July 1, 2010

Study Completion

March 2, 2011

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations

US(1)