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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Under 18 years of age

Identified hearing disorder

Prior history of chronic respiratory failure requiring mechanical ventilation

RASS score of -4, or -5

Trial design

Design model

Parallel

Treatments tested in this trial

  • Toning

    Other intervention

    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 intervention

    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 intervention

    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 intervention

    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

Treatment groups

178 Participants
are divided into 5 treatment groups
Group A: ToningExperimental treatment 1 intervention
Group B: Ocean drum & SOK melodyOther 1 intervention
Group C: SOKExperimental treatment 1 intervention
Group D: ProcessExperimental treatment 1 intervention
Group E: Holding Harmonic ContainerExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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