The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
Primary Purpose
Acute Respiratory Distress Syndrome, Acute Hypoxemic Respiratory Failure, Acute Hypercapnic Respiratory Failure
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Toning
Ocean drum & SOK melody
SOK
Process
Holding Harmonic Container
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Respiratory Distress Syndrome focused on measuring music therapy, song of kin, music medicine
Eligibility 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
Sites / Locations
- Mount Sinai West
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Other
Experimental
Experimental
Experimental
Arm Label
Toning
Ocean drum & SOK melody
SOK
Process
Holding Harmonic Container
Arm Description
Vocal Tonal Holding
Ocean drum followed by melody of song of kin
Song of kin with lyric content
Processing of experience
Outcomes
Primary Outcome Measures
Cumulative Length of Time on Ventilator
Secondary Outcome Measures
Cumulative Length of Stay in Hospital
Respiration Rate
Heart Rate
Oxygen Saturation
Amount of sedation
Richmond Agitation-Sedation Scale (RASS)
RASS is scored from +4 (combative) to -5 (unarousable), with lower score indicating more sedation.
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
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).
Pain score
Numeric Pain Score (for enrollees able to speak). Pain score from 0 (no pain) to 10 (most pain)
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)
ICU length of stay
Full Information
NCT ID
NCT03642002
First Posted
August 15, 2018
Last Updated
April 14, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT03642002
Brief Title
The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
Official Title
The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Acute Hypoxemic Respiratory Failure, Acute Hypercapnic Respiratory Failure
Keywords
music therapy, song of kin, music medicine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Outcomes Assessor will be unfamiliar with desired outcomes
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Toning
Arm Type
Experimental
Arm Description
Vocal Tonal Holding
Arm Title
Ocean drum & SOK melody
Arm Type
Other
Arm Description
Ocean drum followed by melody of song of kin
Arm Title
SOK
Arm Type
Experimental
Arm Description
Song of kin with lyric content
Arm Title
Process
Arm Type
Experimental
Arm Description
Processing of experience
Arm Title
Holding Harmonic Container
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Toning
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Ocean drum & SOK melody
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
SOK
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Process
Intervention Description
Music therapist will process patient experience and provide psycho-education on strategies for using music to promote comfort and enhance breath.
Intervention Type
Other
Intervention Name(s)
Holding Harmonic Container
Intervention Description
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 Measure Information:
Title
Cumulative Length of Time on Ventilator
Time Frame
average 14 days
Secondary Outcome Measure Information:
Title
Cumulative Length of Stay in Hospital
Time Frame
average 14 days
Title
Respiration Rate
Time Frame
15 minute intervals over 30 minute intervention
Title
Heart Rate
Time Frame
15 minute intervals over 30 minute intervention
Title
Oxygen Saturation
Time Frame
15 minute intervals over 30 minute intervention
Title
Amount of sedation
Time Frame
14 days
Title
Richmond Agitation-Sedation Scale (RASS)
Description
RASS is scored from +4 (combative) to -5 (unarousable), with lower score indicating more sedation.
Time Frame
14 days
Title
State-Trait Anxiety Inventory (STAI) (Short Form)
Description
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
Title
Confusion Assessment Method for the ICU (CAM-ICU)
Description
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
Title
Pain score
Description
Numeric Pain Score (for enrollees able to speak). Pain score from 0 (no pain) to 10 (most pain)
Time Frame
14 days
Title
Wong-Baker FACES ® Pain Rating Scale
Description
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
Title
ICU length of stay
Time Frame
average 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Loewy, DA, LCAT, MT-BC
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
http://www.musicandmedicine.org
Description
Related Info
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The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
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