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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03642002
• Other study ID #: GCO 18-1079
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Joanne Loewy, DA, LCAT, MT-BC
• Phone: (212) 420-3484
• Email: joanne.loewy[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Hypercapnic Respiratory Failure
• Acute Hypoxemic Respiratory Failure
• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

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
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.

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

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

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas
United States	Mount Sinai West	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Length of Time on Ventilator		average 14 days
Secondary	Cumulative Length of Stay in Hospital		average 14 days
Secondary	Respiration Rate		15 minute intervals over 30 minute intervention
Secondary	Heart Rate		15 minute intervals over 30 minute intervention
Secondary	Oxygen Saturation		15 minute intervals over 30 minute intervention
Secondary	Amount of sedation		14 days
Secondary	Richmond Agitation-Sedation Scale (RASS)	RASS is scored from +4 (combative) to -5 (unarousable), with lower score indicating more sedation.	14 days
Secondary	State-Trait Anxiety Inventory (STAI) (Short Form)	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	14 days
Secondary	Confusion Assessment Method for the ICU (CAM-ICU)	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).	14 days
Secondary	Pain score	Numeric Pain Score (for enrollees able to speak). Pain score from 0 (no pain) to 10 (most pain)	14 days
Secondary	Wong-Baker FACES ® Pain Rating Scale	Wong-Baker FACES ® Pain Rating Scale (for enrollees unable to speak). Pain score from 0 (no pain) to 10 (most pain)	14 days
Secondary	ICU length of stay		average 14 days

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