Recruiting

Music Therapy

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT03642002

Conditions

Acute Respiratory Distress Syndrome

Acute Hypoxemic Respiratory Failure

Acute Hypercapnic Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Toning

Ocean drum & SOK melody

SOK

Process

Holding Harmonic Container

Study Details

Brief summary:

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.

Conditions

Acute Respiratory Distress Syndrome

Acute Hypoxemic Respiratory Failure

Acute Hypercapnic Respiratory Failure

Study ID

NCT03642002

Start date

Dec 12, 2018

Status verified date

Apr, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

178 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Toning

Vocal Tonal Holding

other: Ocean drum & SOK melody

Ocean drum followed by melody of song of kin

experimental: SOK

Song of kin with lyric content

experimental: Process

Processing of experience

experimental: Holding Harmonic Container

Interventions

Toning

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

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

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

Music therapist will process patient experience and provide psycho-education on strategies for using music to promote comfort and enhance breath.

Holding Harmonic Container

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

Primary outcome measure

  • Cumulative Length of Time on Ventilator [ Time Frame: average 14 days ]

Central Contacts and Locations

Central contacts

Joanne Loewy, DA, LCAT, MT-BC

(212) 420-3484joanne.loewy@mountsinai.org

Christopher Pizzute, MA, LCAT-LP, MT-BC

(212) 636-3112Christopher.Pizzute2@mountsinai.org

Locations

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Contacts

Joanne Loewy, DA, LCAT, MT-BC

(212) 420-3484joanne.loewy@mountsinai.org

Christopher Pizzute, MA, LCAT-LP, MT-BC

(212) 636-3112Christopher.Pizzute2@mountsinai.org

Principal Investigator:

Joanne Loewy, DA, LCAT, MT-BC

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Jennifer Townsend, Master of Music Therapy

713-441-9231jdtownsend@houstonmethodist.org

Principal Investigator:

Jennifer Townsend, Master of Music Therapy

Houston Methodist Research Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

Jennifer Townsend

713-441-9231jdtownsend@houstonmethodist.org

Principal Investigator:

Jennifer Townsend

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Apr 9, 2025

Last verified

Apr, 2025

Keywords

  • music therapy
  • song of kin
  • music medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-04-09.