The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU

NCT ID: NCT03642002

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-12

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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The study will include 178 adult patients on mechanical ventilation. These patients will be randomly assigned to the music therapy group or control group and matched for diagnosis, co-morbidities, age, and gender. The music therapy group will utilize a certified music therapist to provide live music based on the patient's cultural preferences and entrainment. The primary outcome is a reduction in mechanical ventilation hours of 35% compared to the control group. Secondary outcomes include: Amount of sedation, Richmond Agitation-Sedation Scale (RASS), delirium and pain score, ICU and hospital length of stay. The researchers hypothesize that live entrained music therapy compared to control will result in a reduction in the time of extubation, amount of sedation administered, ICU and hospital length of stay.

Conditions

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Acute Respiratory Distress Syndrome Acute Hypoxemic Respiratory Failure Acute Hypercapnic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Outcomes Assessor will be unfamiliar with desired outcomes
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Toning

Vocal Tonal Holding

Group Type EXPERIMENTAL

Toning

Intervention Type 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

Ocean drum followed by melody of song of kin

Group Type OTHER

Ocean drum & SOK melody

Intervention Type 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

Song of kin with lyric content

Group Type EXPERIMENTAL

SOK

Intervention Type 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

Processing of experience

Group Type EXPERIMENTAL

Process

Intervention Type 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

Group Type EXPERIMENTAL

Holding Harmonic Container

Intervention Type 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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

Process

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

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Joanne Loewy

Director, Louis Armstrong Center for Music and Medicine at Mount Sinai Beth Israel

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joanne Loewy, DA, LCAT, MT-BC

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai West

New York, New York, United States

Site Status RECRUITING

Houston Methodist Hospital

Houston, Texas, United States

Site Status RECRUITING

Houston Methodist Research Institute

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joanne Loewy, DA, LCAT, MT-BC

Role: CONTACT

(212) 420-3484

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

Role: CONTACT

(212) 636-3112

Facility Contacts

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Joanne Loewy, DA, LCAT, MT-BC

Role: primary

(212) 420-3484

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

Role: backup

(212) 636-3112

Jennifer Townsend, Master of Music Therapy

Role: primary

713-441-9231

Jennifer Townsend

Role: primary

713-441-9231

References

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Chlan LL. Psychophysiologic responses of mechanically ventilated patients to music: a pilot study. Am J Crit Care. 1995 May;4(3):233-8.

Reference Type BACKGROUND
PMID: 7787918 (View on PubMed)

Canga B, Azoulay R, Raskin J, Loewy J. AIR: Advances in Respiration - Music therapy in the treatment of chronic pulmonary disease. Respir Med. 2015 Dec;109(12):1532-9. doi: 10.1016/j.rmed.2015.10.001. Epub 2015 Oct 19.

Reference Type BACKGROUND
PMID: 26522499 (View on PubMed)

Chlan L. Effectiveness of a music therapy intervention on relaxation and anxiety for patients receiving ventilatory assistance. Heart Lung. 1998 May-Jun;27(3):169-76. doi: 10.1016/s0147-9563(98)90004-8.

Reference Type BACKGROUND
PMID: 9622403 (View on PubMed)

Chlan LL. Music therapy as a nursing intervention for patients supported by mechanical ventilation. AACN Clin Issues. 2000 Feb;11(1):128-38. doi: 10.1097/00044067-200002000-00014.

Reference Type BACKGROUND
PMID: 11040559 (View on PubMed)

Conti G, Mantz J, Longrois D, Tonner P. Sedation and weaning from mechanical ventilation: time for 'best practice' to catch up with new realities? Multidiscip Respir Med. 2014 Aug 29;9(1):45. doi: 10.1186/2049-6958-9-45. eCollection 2014.

Reference Type BACKGROUND
PMID: 25473522 (View on PubMed)

Erdogan Z, Atik D. Complementary Health Approaches Used in the Intensive Care Unit. Holist Nurs Pract. 2017 Sep/Oct;31(5):325-342. doi: 10.1097/HNP.0000000000000227.

Reference Type BACKGROUND
PMID: 28786890 (View on PubMed)

Hetland B, Lindquist R, Weinert CR, Peden-McAlpine C, Savik K, Chlan L. Predictive Associations of Music, Anxiety, and Sedative Exposure on Mechanical Ventilation Weaning Trials. Am J Crit Care. 2017 May;26(3):210-220. doi: 10.4037/ajcc2017468.

Reference Type BACKGROUND
PMID: 28461543 (View on PubMed)

Hunter BC, Oliva R, Sahler OJ, Gaisser D, Salipante DM, Arezina CH. Music therapy as an adjunctive treatment in the management of stress for patients being weaned from mechanical ventilation. J Music Ther. 2010 Fall;47(3):198-219. doi: 10.1093/jmt/47.3.198.

Reference Type BACKGROUND
PMID: 21275332 (View on PubMed)

Jaber S, Bahloul H, Guetin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. doi: 10.1016/j.annfar.2006.09.002. Epub 2006 Nov 3. French.

Reference Type BACKGROUND
PMID: 17085009 (View on PubMed)

Lee CH, Lee CY, Hsu MY, Lai CL, Sung YH, Lin CY, Lin LY. Effects of Music Intervention on State Anxiety and Physiological Indices in Patients Undergoing Mechanical Ventilation in the Intensive Care Unit. Biol Res Nurs. 2017 Mar;19(2):137-144. doi: 10.1177/1099800416669601. Epub 2016 Sep 21.

Reference Type BACKGROUND
PMID: 27655993 (View on PubMed)

Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.

Reference Type BACKGROUND
PMID: 23589814 (View on PubMed)

Loewy J, Hallan C, Friedman E, Martinez C. Sleep/sedation in children undergoing EEG testing: a comparison of chloral hydrate and music therapy. Am J Electroneurodiagnostic Technol. 2006 Dec;46(4):343-55.

Reference Type BACKGROUND
PMID: 17285817 (View on PubMed)

Lindgren VA, Ames NJ. Caring for patients on mechanical ventilation: what research indicates is best practice. Am J Nurs. 2005 May;105(5):50-60; quiz 61. doi: 10.1097/00000446-200505000-00029. No abstract available.

Reference Type BACKGROUND
PMID: 15867534 (View on PubMed)

Zilberberg MD, Shorr AF. Prolonged acute mechanical ventilation and hospital bed utilization in 2020 in the United States: implications for budgets, plant and personnel planning. BMC Health Serv Res. 2008 Nov 25;8:242. doi: 10.1186/1472-6963-8-242.

Reference Type BACKGROUND
PMID: 19032766 (View on PubMed)

Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

Reference Type BACKGROUND
PMID: 24088092 (View on PubMed)

Other Identifiers

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GCO 18-1079

Identifier Type: -

Identifier Source: org_study_id

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