What this study is
While most studies in the medical literature that indicate "music" as an intervention may recognize its impact and capacity to decrease pain perception, anxiety, and/or its role in the regulation of cardiac and respiratory function in ICU patients, no identifiable studies have implemented entrained live music therapy protocols into clinical trials. Music therapy treatment is a non-pharmacological intervention that is individually tailored to the patient's needs and focuses on the assessment and intervention of a specific music application that is provided by a certified music therapist. Entrained music therapy focuses on a dynamic interaction between the patient and music therapist in which the music therapist attempts to promote relaxation and comfort through the patient's identified Song of Kin (SOK). This study measures the effects of live music therapy entrained to the vital signs of adult patients on duration of mechanical ventilation.
What's being tested
- Toning
Intervention · OTHER
Music therapist will begin gentle breathing and toning on a descending "Ah" vowel to stimulate vibration in the chest and increase awareness of the breath. The patient will be encouraged to join the music therapist as is comfortable
- Ocean drum & SOK melody
Intervention · OTHER
Music therapist will introduce ocean drum to mimic breathing sounds and will hum the melody of Song of Kin to begin entrainment process. Patient will be invited to join the music therapist in humming as is comfortable
- SOK
Intervention · OTHER
Music therapist will introduce sung lyric content of Song of Kin accompanied on guitar. Patient will be invited to sing with music therapist as is comfortable.
- Process
Intervention · BEHAVIORAL
Music therapist will process patient experience and provide psycho-education on strategies for using music to promote comfort and enhance breath.
- Holding Harmonic Container
Intervention · OTHER
Music therapist will provide a holding harmonic container of IM7 - IVM7 and will improvise a repeating melody on "ah" based on the ambient sounds in the patient's immediate environment
Study details
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Acute Respiratory Distress Syndrome · Acute Hypoxemic Respiratory Failure · Acute Hypercapnic Respiratory Failure
- Enrolling
- 178 people
- Starts
- 2018-12-12
- Est. completion
- 2028-12
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adult patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and ARDS admitted to the ICU requiring mechanical ventilation
- Patients that are anticipated to remain on invasive mechanical ventilation for 48 hours or more will be screened for participation in the study
You can't join if
- Under 18 years of age
- Identified hearing disorder
- Prior history of chronic respiratory failure requiring mechanical ventilation
- RASS score of -4, or -5
- Active seizures, or status epilepticus
- Cardiac arrest
- Coma
- End of life
- More than 2 vasopressors
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openContact for 2 of 3 open sites
- Jennifer Townsend, Master of Music Therapy · Contact713-441-9231jdtownsend@houstonmethodist.org
- Jennifer Townsend, Master of Music Therapy · Principal investigator
Mount Sinai West
New York, New York, United States
- Joanne Loewy, DA, LCAT, MT-BC · Contact(212) 420-3484joanne.loewy@mountsinai.org
- Christopher Pizzute, MA, LCAT-LP, MT-BC · Contact(212) 636-3112Christopher.Pizzute2@mountsinai.org
- Joanne Loewy, DA, LCAT, MT-BC · Principal investigator
RecruitingHouston Methodist Hospital
Houston, Texas, United States
RecruitingHouston Methodist Research Institute
Houston, Texas, United States
Recruiting
Study team
Sponsor
Icahn School of Medicine at Mount Sinai
Study ID GCO 18-1079
Principal investigator
Joanne Loewy, DA, LCAT, MT-BC
Icahn School of Medicine at Mount Sinai
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.