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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toning | Experimental | Vocal Tonal Holding |
|
| Ocean drum & SOK melody | Other | Ocean drum followed by melody of song of kin |
|
| SOK | Experimental | Song of kin with lyric content |
|
| Process | Experimental | Processing of experience |
|
| Holding Harmonic Container | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Length of Time on Ventilator | average 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Length of Stay in Hospital | average 14 days | |
| Respiration Rate | 15 minute intervals over 30 minute intervention | |
| Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Joanne Loewy, DA, LCAT, MT-BC | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West | Recruiting | New York | New York | 10019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7787918 | Background | Chlan LL. Psychophysiologic responses of mechanically ventilated patients to music: a pilot study. Am J Crit Care. 1995 May;4(3):233-8. | |
| 26522499 | 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. |
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Outcomes Assessor will be unfamiliar with desired outcomes
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| 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 |
|
| 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. |
|
| Process | 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 | 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 |
|
| 15 minute intervals over 30 minute intervention |
| Oxygen Saturation | 15 minute intervals over 30 minute intervention |
| Amount of sedation | 14 days |
| Richmond Agitation-Sedation Scale (RASS) | RASS is scored from +4 (combative) to -5 (unarousable), with lower score indicating more sedation. | 14 days |
| State-Trait Anxiety Inventory (STAI) (Short Form) | To calculate the total STAI score (range 20-80):
| 14 days |
| 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 |
| Pain score | Numeric Pain Score (for enrollees able to speak). Pain score from 0 (no pain) to 10 (most pain) | 14 days |
| 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 |
| ICU length of stay | average 14 days |
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
|
| Houston Methodist Research Institute | Recruiting | Houston | Texas | 77030 | United States |
|
| 9622403 | 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. |
| 11040559 | 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. |
| 25473522 | 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. |
| 28786890 | 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. |
| 28461543 | 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. |
| 21275332 | 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. |
| 17085009 | 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. |
| 27655993 | 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. |
| 23589814 | 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. |
| 17285817 | 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. |
| 15867534 | 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. |
| 19032766 | 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. |
| 24088092 | 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. |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D017348 | Microscopy, Electron, Scanning Transmission |
| ID | Term |
|---|---|
| D046529 | Microscopy, Electron, Transmission |
| D008854 | Microscopy, Electron |
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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