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Recruiting NCT03642002

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

No phase Interventional Acute Respiratory Distress Syndrome Acute Hypoxemic Respiratory Failure Acute Hypercapnic Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Toning, Ocean drum & SOK melody, SOK, Process.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome, Acute Hypoxemic Respiratory Failure, Acute Hypercapnic Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Interventions

  • 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
  • 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
  • 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.
  • 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

Primary outcome measures

  • Cumulative Length of Time on Ventilator [Time frame: average 14 days]
Secondary outcome measures (11)
  • Cumulative Length of Stay in Hospital [Time frame: average 14 days]
  • Respiration Rate [Time frame: 15 minute intervals over 30 minute intervention]
  • Heart Rate [Time frame: 15 minute intervals over 30 minute intervention]
  • Oxygen Saturation [Time frame: 15 minute intervals over 30 minute intervention]
  • Amount of sedation [Time frame: 14 days]
  • Richmond Agitation-Sedation Scale (RASS) [Time frame: 14 days]
  • State-Trait Anxiety Inventory (STAI) (Short Form) [Time frame: 14 days]
  • Confusion Assessment Method for the ICU (CAM-ICU) [Time frame: 14 days]
  • Pain score [Time frame: 14 days]
  • Wong-Baker FACES ® Pain Rating Scale [Time frame: 14 days]
  • ICU length of stay [Time frame: average 14 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 3 centers
  • Mount Sinai West — New York
  • Houston Methodist Hospital — Houston
  • Houston Methodist Research Institute — Houston

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT03642002 · GCO 18-1079

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗