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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03642002
Other study ID # GCO 18-1079
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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 allClick 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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