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NCT Number: NCT03642002

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai West, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Cumulative Length of Time on Ventilator

    Time frame: average 14 days

Secondary outcomes

  1. Cumulative Length of Stay in Hospital

    Time frame: average 14 days

  2. Respiration Rate

    Time frame: 15 minute intervals over 30 minute intervention

  3. Heart Rate

    Time frame: 15 minute intervals over 30 minute intervention

  4. Oxygen Saturation

    Time frame: 15 minute intervals over 30 minute intervention

  5. Amount of sedation

    Time frame: 14 days

  6. Richmond Agitation-Sedation Scale (RASS)

    Time frame: 14 days

    RASS is scored from +4 (combative) to -5 (unarousable), with lower score indicating more sedation.

  7. State-Trait Anxiety Inventory (STAI) (Short Form)

    Time frame: 14 days

    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
  8. Confusion Assessment Method for the ICU (CAM-ICU)

    Time frame: 14 days

    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).

  9. Pain score

    Time frame: 14 days

    Numeric Pain Score (for enrollees able to speak). Pain score from 0 (no pain) to 10 (most pain)

  10. Wong-Baker FACES ® Pain Rating Scale

    Time frame: 14 days

    Wong-Baker FACES ® Pain Rating Scale (for enrollees unable to speak). Pain score from 0 (no pain) to 10 (most pain)

  11. ICU length of stay

    Time frame: average 14 days

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Pizzute, MA, LCAT-LP, MT-BC

CONTACT

[email protected]

(212) 636-3112

Joanne Loewy, DA, LCAT, MT-BC

CONTACT

[email protected]

(212) 420-3484

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Aug 22, 2018
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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