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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Cumulative Length of Time on Ventilator [Срок оценки: average 14 days]

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Mount Sinai West — New York
• Houston Methodist Hospital — Houston
• Houston Methodist Research Institute — Houston

Публикации

• 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

Идентификаторы

NCT: NCT03642002 · GCO 18-1079

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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