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

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ClinicalTrials.gov Identifier: NCT03642002
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Acute Hypoxemic Respiratory Failure Acute Hypercapnic Respiratory Failure Other: Toning Other: Ocean drum & SOK melody Other: SOK Behavioral: Process Other: Holding Harmonic Container Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Outcomes Assessor will be unfamiliar with desired outcomes
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Experimental: Toning
Vocal Tonal Holding
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

Ocean drum & SOK melody
Ocean drum followed by melody of song of kin
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

Experimental: SOK
Song of kin with lyric content
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.

Experimental: Process
Processing of experience
Behavioral: Process
Music therapist will process patient experience and provide psycho-education on strategies for using music to promote comfort and enhance breath.

Experimental: Holding Harmonic Container 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 :
  1. Cumulative Length of Time on Ventilator [ Time Frame: average 14 days ]

Secondary Outcome Measures :
  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 (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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642002


Contacts
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Contact: Joanne Loewy, DA, LCAT, MT-BC (212) 420-3484 joanne.loewy@mountsinai.org

Locations
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United States, New York
Mount Sinai West Recruiting
New York, New York, United States, 10019
Contact: Joanne Loewy, DA, LCAT, MT-BC    (212) 420-3484    joanne.loewy@mountsinai.org   
Contact: Shanay Johnson, MA, LCAT, MT-BC    (212) 636-4617    shanay.johnson@mountsinai.org   
Principal Investigator: Joanne Loewy, DA, LCAT, MT-BC         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Joanne Loewy, DA, LCAT, MT-BC Icahn School of Medicine at Mount Sinai
Study Chair: Shanay Johnson, MA, LCAT, MT-BC Icahn School of Medicine at Mount Sinai
Study Chair: John Mondanaro, MA, LCAT, MT-BC, CCLS Icahn School of Medicine at Mount Sinai

Additional Information:
Publications:

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03642002     History of Changes
Other Study ID Numbers: GCO 18-1079
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
music therapy
song of kin
music medicine

Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Hypercapnia
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Signs and Symptoms, Respiratory
Signs and Symptoms