Intensive Care UnitPhase 1MTS2NCT00823017
Effect of Music on Patients in Intensive Care Units
A Phase 1 study testing Patient-preferred music and Relaxation Music in people with Intensive Care Unit, run by MetroHealth Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit
- What is being tested?
- Patient-preferred music and Relaxation Music
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to 2 Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Intensive Care Unit
- Being tested
- Patient-preferred music, Relaxation Music, Standard Care Environment
- Keywords
- ICU environment, Auditory stimulation, Properties of relaxation music, music, music therapy, pain, anxiety, cortisol, IgA, biomarkers, relaxation music
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-preferred musicOther
Music of patients' preference
Relaxation MusicOther
Relaxation music compiled from results of first three stages of study
Standard Care EnvironmentOther
Control, no interventions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patient-preferred music Receives: Other: Patient-preferred music |
| 2 | Experimental | Relaxation Music Receives: Other: Relaxation Music |
| 3 | Placebo comparator | Standard of Care Receives: Other: Standard Care Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Measured: 4 data points throughout 1-hour intervention
Anxiety level
Measured: 4 data points throughout 1-hour intervention
Comfort level
Measured: 4 data points throughout 1-hour intervention
Heart rate
Measured: 4 data points throughout 1-hour intervention
Respiration rate
Measured: 4 data points throughout 1-hour intervention
Blood pressure
Measured: 4 data points throughout 1-hour intervention
Saliva/Serum Cortisol level
Measured: 3 data points throughout 1-hour intervention
Saliva/Serum Immunoglobulin A Concentration
Measured: 3 data points throughout 1-hour intervention
Secondary outcomes (1)
Psychophysical properties of relaxation music
Measured: 1 rating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJul 2006
- Primary completionJul 2010
- Study completion2 Mar 2011
Why it stopped: study withdrawn from IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Music School Settlement, Kulas Foundation, Arthur Flagler Fultz Research Award (American Music Therapy Association)
- Responsible party
- Principal investigator, Charles J. Yowler MD, MetroHealth Medical Center
- Investigators
- Xueli Tan, MM, MT-BC, Study chair, The Cleveland Music School SettlementRichard B Fratianne, MD, FACS, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823017
- Sponsor's protocol ID
- IRB06-00070
- Acronym
- MTS2
- Status last verified
- May 2018
- First submitted
- 14 Jan 2009
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient-Preferred Music, Relaxation Music, and Standard Care Environment on Patients in Intensive Care Units
- ClinicalTrials.gov ID
- NCT00823017
- Acronym / sponsor ID
- MTS2 / IRB06-00070
- Conditions
- Intensive Care Unit
- Keywords
- ICU environment, Auditory stimulation, Properties of relaxation music, music, music therapy, pain, anxiety, cortisol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study withdrawn from IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- The Cleveland Music School Settlement, Kulas Foundation, Arthur Flagler Fultz Research Award (American Music Therapy Association)
- Study start
- Jul 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- 2 Mar 2011 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Patient-preferred musicPatient-preferred music |
| 2 | Experimental | Other: Relaxation MusicRelaxation Music |
| 3 | Placebo comparator | Other: Standard Care EnvironmentStandard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-preferred musicMusic of patients' preference | Other | 1 |
| Relaxation MusicRelaxation music compiled from results of first three stages of study | Other | 2 |
| Standard Care EnvironmentControl, no interventions | Other | 3 |
Primary outcome
Pain level
Time frame: 4 data points throughout 1-hour intervention
Anxiety level
Time frame: 4 data points throughout 1-hour intervention
Comfort level
Time frame: 4 data points throughout 1-hour intervention
Heart rate
Time frame: 4 data points throughout 1-hour intervention
Respiration rate
Time frame: 4 data points throughout 1-hour intervention
Blood pressure
Time frame: 4 data points throughout 1-hour intervention
Saliva/Serum Cortisol level
Time frame: 3 data points throughout 1-hour intervention
Saliva/Serum Immunoglobulin A Concentration
Time frame: 3 data points throughout 1-hour intervention
1 secondary outcome
Psychophysical properties of relaxation music
Time frame: 1 rating
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xueli Tan, MM, MT-BC study chair
The Cleveland Music School Settlement
Richard B Fratianne, MD, FACS principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Patient-preferred music and Relaxation Music in people with Intensive Care Unit, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 4 data points throughout 1-hour intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.