The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
Part of paid clinical trials in New York, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT03642002
- Status
- Recruiting
Conditions
- Acute Hypercapnic Respiratory Failure
- Acute Hypoxemic Respiratory Failure
- Acute Respiratory Distress Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Toning — OTHERMusic 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 — OTHERMusic 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 — OTHERMusic 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 — BEHAVIORALMusic therapist will process patient experience and provide psycho-education on strategies for using music to promote comfort and enhance breath.
- Holding Harmonic Container — OTHERMusic 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
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.
Key Dates
- Start date
- Dec 12, 2018
- Status verified
- Apr 2025
- Primary completion
- Apr 30, 2027
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 178 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: ToningVocal Tonal Holding
- Other: Ocean drum & SOK melodyOcean drum followed by melody of song of kin
- Experimental: SOKSong of kin with lyric content
- Experimental: ProcessProcessing of experience
- Experimental: Holding Harmonic Container
Primary Outcome Measure
Cumulative Length of Time on Ventilator [ Time Frame: average 14 days ]
Central Contacts
- Joanne Loewy, DA, LCAT, MT-BC(212) 420-3484
- Christopher Pizzute, MA, LCAT-LP, MT-BC(212) 636-3112
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mount Sinai West | New York | New York | 10019 | Joanne Loewy, DA, LCAT, MT-BC (PRINCIPAL_INVESTIGATOR) |
| Houston Methodist Hospital | Houston | Texas | 77030 | Jennifer Townsend, Master of Music Therapy (PRINCIPAL_INVESTIGATOR) |
| Houston Methodist Research Institute | Houston | Texas | 77030 | Jennifer Townsend (PRINCIPAL_INVESTIGATOR) |
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