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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
178
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
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
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.
Music therapist will process patient experience and provide psycho-education on strategies for using music to promote comfort and enhance breath.
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
Mount Sinai West
New York, New York, United States
RECRUITINGHouston Methodist Hospital
Houston, Texas, United States
RECRUITINGHouston Methodist Research Institute
Houston, Texas, United States
RECRUITINGCumulative Length of Time on Ventilator
Time frame: average 14 days
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)
RASS is scored from +4 (combative) to -5 (unarousable), with lower score indicating more sedation.
Time frame: 14 days
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
Time frame: 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).
Time frame: 14 days
Pain score
Numeric Pain Score (for enrollees able to speak). Pain score from 0 (no pain) to 10 (most pain)
Time frame: 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)
Time frame: 14 days
ICU length of stay
Time frame: average 14 days
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