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

NCT03642002 | Recruiting

• 1 other identifier: GCO 18-1079
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

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

Keywords

music therapy; song of kin; music medicine

Outcome Measures

Primary Outcomes (1)

• Cumulative Length of Time on Ventilator

  average 14 days

Secondary Outcomes (11)

• Cumulative Length of Stay in Hospital

  average 14 days

• Respiration Rate

  15 minute intervals over 30 minute intervention

• Heart Rate

  15 minute intervals over 30 minute intervention

• Oxygen Saturation

  15 minute intervals over 30 minute intervention

• Amount of sedation

  14 days

Study Arms (5)

Toning

EXPERIMENTAL

Vocal Tonal Holding

Other: Toning

Ocean drum & SOK melody

OTHER

Ocean drum followed by melody of song of kin

Other: Ocean drum & SOK melody

SOK

EXPERIMENTAL

Song of kin with lyric content

Other: SOK

Process

EXPERIMENTAL

Processing of experience

Behavioral: Process

Holding Harmonic Container

EXPERIMENTAL

Other: Holding Harmonic Container

Interventions

Toning 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

Toning

Ocean drum & SOK melody 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

Ocean drum & SOK melody

SOK 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.

SOK

Process BEHAVIORAL

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

Process

Holding Harmonic Container 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

Holding Harmonic Container

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (3)

Mount Sinai West

New York, New York, 10019, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist Research Institute

Houston, Texas, 77030, United States

RECRUITING

Related Publications (15)

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

  PMID: 7787918 BACKGROUND

• 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.

  PMID: 26522499 BACKGROUND

• 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.

  PMID: 9622403 BACKGROUND

• 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.

  PMID: 11040559 BACKGROUND

• 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.

  PMID: 25473522 BACKGROUND

• 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.

  PMID: 28786890 BACKGROUND

• 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.

  PMID: 28461543 BACKGROUND

• 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.

  PMID: 21275332 BACKGROUND

• 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.

  PMID: 17085009 BACKGROUND

• 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.

  PMID: 27655993 BACKGROUND

• 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.

  PMID: 23589814 BACKGROUND

• 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.

  PMID: 17285817 BACKGROUND

• 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.

  PMID: 15867534 BACKGROUND

• 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.

  PMID: 19032766 BACKGROUND

• 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.

  PMID: 24088092 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency

Interventions

Microscopy, Electron, Scanning Transmission

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Microscopy, Electron, Transmission; Microscopy, Electron; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Joanne Loewy, DA, LCAT, MT-BC

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne Loewy, DA, LCAT, MT-BC

CONTACT

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

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Louis Armstrong Center for Music and Medicine at Mount Sinai Beth Israel

Model Details: Outcomes Assessor will be unfamiliar with desired outcomes

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 22, 2018
• Study Start: December 12, 2018
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)