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

• ClinicalTrials.gov Identifier: NCT03642002
• Recruitment Status: Recruiting
• First Posted: August 22, 2018
• Last Update Posted: September 23, 2021
• Sponsor: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): Joanne Loewy, Icahn School of Medicine at Mount Sinai

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Respiratory Distress Syndrome; Acute Hypoxemic Respiratory Failure; Acute Hypercapnic Respiratory Failure	Other: Toning; Other: Ocean drum & SOK melody; Other: SOK; Behavioral: Process; Other: Holding Harmonic Container	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 178 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Outcomes Assessor will be unfamiliar with desired outcomes
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
• Actual Study Start Date: December 12, 2018
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: January 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Toning; Vocal Tonal Holding	Other: 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; Ocean drum followed by melody of song of kin	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
Experimental: SOK; Song of kin with lyric content	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.
Experimental: Process; Processing of experience	Behavioral: Process; Music therapist will process patient experience and provide psycho-education on strategies for using music to promote comfort and enhance breath.
Experimental: Holding Harmonic Container	Other: 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Cumulative Length of Stay in Hospital [ Time Frame: average 14 days ]
2. Respiration Rate [ Time Frame: 15 minute intervals over 30 minute intervention ]
3. Heart Rate [ Time Frame: 15 minute intervals over 30 minute intervention ]
4. Oxygen Saturation [ Time Frame: 15 minute intervals over 30 minute intervention ]
5. Amount of sedation [ Time Frame: 14 days ]
6. Richmond Agitation-Sedation Scale (RASS) [ Time Frame: 14 days ]
   RASS is scored from +4 (combative) to -5 (unarousable), with lower score indicating more sedation.
7. State-Trait Anxiety Inventory (Short Form) [ Time Frame: 14 days ]

   To calculate the total STAI score (range 20-80):

   • Reverse scoring of the positive items (calm, relaxed, content) so 1=4, 2=3, 3=2, and 4=1;
   • Sum all six scores;
   • Multiply total score by 20/6
   • Scores are interpreted such that a "normal" score is approximately 24-36, Higher score indicates more anxiety
8. Confusion Assessment Method for the ICU (CAM-ICU) [ Time Frame: 14 days ]
   CAM-ICU is a delirium monitoring instrument for ICU patients, scored for two possibilities: CAM-ICU Positive (where delirium is present for a patient) or CAM-ICU Negative (where delirium is not present for a patient).
9. Pain score [ Time Frame: 14 days ]
   Numeric Pain Score (for enrollees able to speak). Pain score from 0 (no pain) to 10 (most pain)
10. Wong-Baker FACES ® Pain Rating Scale [ Time Frame: 14 days ]
    Wong-Baker FACES ® Pain Rating Scale (for enrollees unable to speak). Pain score from 0 (no pain) to 10 (most pain)
11. ICU length of stay [ Time Frame: average 14 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Joanne Loewy, DA, LCAT, MT-BC; (212) 420-3484; joanne.loewy@mountsinai.org

Contact: Gabrielle Bouissou, MS, LCAT, MT-BC; (212) 420-2719; Gabrielle.Bouissou@mountsinai.org

Locations

United States, New York

Mount Sinai West; Recruiting

New York, New York, United States, 10019

Contact: Joanne Loewy, DA, LCAT, MT-BC (212) 420-3484 joanne.loewy@mountsinai.org

Contact: Gabrielle Bouissou, MS, LCAT, MT-BC (212) 420-2719 Gabrielle.Bouissou@mountsinai.org

Principal Investigator: Joanne Loewy, DA, LCAT, MT-BC

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Joanne Loewy, DA, LCAT, MT-BC; Icahn School of Medicine at Mount Sinai
• Study Chair: John Mondanaro, MA, LCAT, MT-BC, CCLS; Icahn School of Medicine at Mount Sinai

More Information

Additional Information:

Related Info 

Publications:

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

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.

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.

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

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. Review.

Erdoğan 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.

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Jaber S, Bahloul H, Guétin 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. Epub 2006 Nov 3. French.

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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.

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.

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. Review.

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.

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.

• Responsible Party: Joanne Loewy, Director, Louis Armstrong Center for Music and Medicine at Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT03642002
• Other Study ID Numbers: GCO 18-1079
• First Posted: August 22, 2018
• Last Update Posted: September 23, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joanne Loewy, Icahn School of Medicine at Mount Sinai:

music therapy; song of kin; music medicine

Additional relevant MeSH terms:

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury