Feasibility of Music Therapy for Spontaneous Breathing Trials
Primary Purpose
Spontaneous Breathing Trial, Intubation, Mechanical Ventilation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music therapy plus standard care during an SBT
Standard care during an SBT
Sponsored by
About this trial
This is an interventional supportive care trial for Spontaneous Breathing Trial
Eligibility Criteria
Inclusion Criteria:
- Adults 18+
- Admitted to MUSC's Main Hospital medical intensive care unit (MICU) or Ashley River Tower medical-surgical intensive care unit (MSICU)
- Intubated and will undergo a spontaneous breathing trial
Exclusion Criteria:
- Patients who have had any prior SBTs
- Patients known to have a neurological injury
- Patients who are known to be deaf
- Patients whom (or whose LAR) are unable or unwilling to give informed consent.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Music Therapy plus Standard Care
Standard Care
Arm Description
Music therapy intervention in addition to standard hospital care during an SBT.
Standard hospital care during an SBT.
Outcomes
Primary Outcome Measures
Proportion of successful initial spontaneous breathing trials (SBTs) vs failed initial SBTs
A successful SBT is defined as when a patient sustains at least 30 minutes without mechanical ventilator support, as deemed by the respiratory therapist in the participant's chart.
A failed SBT is defined as when a patient requires mechanical ventilator support within 30 minutes of the start of the SBT, as deemed by the respiratory therapist.
Secondary Outcome Measures
Mean minutes sustained off ventilator support for failed SBTs
Total minutes sustained off ventilator support, as noted by respiratory therapist in the participant's chart.
Mean score of heart rate at points throughout SBT
Recording of patient's heart rate via observation of monitor at three points throughout the SBT
Mean score of respiratory rate at points throughout SBT
Recording of patient's respiratory rate via observation of monitor at three points throughout the SBT
Mean score of blood pressure at points throughout SBT
Recording of patient's blood pressure via observation of monitor at three points throughout the SBT
Mean score of agitation as assessed by the Richmond Agitation-Sedation Scale at points throughout SBT
4 Combative- Overtly combative, violent, immediate danger to staff
3 Very agitated- Pulls or removes tube(s) or catheter(s); aggressive
2 Agitated- Frequent non-purposeful movement, fights ventilator
1 Restless- Anxious but movements not aggressive vigorous 0 Alert and calm
1 Drowsy- Not fully alert, but has sustained awakening (eye opening/contact) to voice (>10 seconds)
2 Light sedation- Briefly awakens with eye contact to voice (<10 seconds)
3 Moderate sedation- Movement or eye opening to voice (but no eye contact)
4 Deep sedation- No response to voice, but movement or eye opening to physical stimulation
5 Unarousable- No response to voice or physical stimulation
Full Information
NCT ID
NCT05008328
First Posted
July 28, 2021
Last Updated
January 26, 2023
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT05008328
Brief Title
Feasibility of Music Therapy for Spontaneous Breathing Trials
Official Title
Feasibility of Live, Receptive Music Therapy for Patients Undergoing Spontaneous Breathing Trials: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Study team decided to conclude the study and report it as a feasibility study.
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
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
In this study, the investigators will study music therapy for patients during breathing trials, a procedure performed in intensive care units. Participants will be assigned either to standard medical care or standard medical care plus music therapy. Participants have a 50/50 chance (like flipping a coin) of being in either group. In the music therapy group, a board-certified music therapist will sing softly with guitar accompaniment to provide music during the breathing trial. The music is in addition to the usual treatment provided by hospital staff. Participants in the standard medical care group will receive the usual medical care given by hospital staff members. Information will be collected from participant's charts and by observation of vital signs during the breathing trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Breathing Trial, Intubation, Mechanical Ventilation, Music Therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music Therapy plus Standard Care
Arm Type
Experimental
Arm Description
Music therapy intervention in addition to standard hospital care during an SBT.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Standard hospital care during an SBT.
Intervention Type
Other
Intervention Name(s)
Music therapy plus standard care during an SBT
Intervention Description
If the participant is randomly assigned to standard care plus music therapy, a music therapist will enter the room five minutes prior to the start of the breathing trial and begin to play quiet music on a guitar. The nurse will reduce medicine to bring the participant to an alert state. The music therapist will introduce themselves and the music intervention, and will continue to play quiet guitar music and sing softly while the respiratory therapist begins the breathing trial. The music therapist will continue playing and singing for 20 minutes into the breathing trial.
Intervention Type
Procedure
Intervention Name(s)
Standard care during an SBT
Intervention Description
The patient's nurse will reduce sedatives so the patient is alert and awake. The respiratory therapist will introduce themselves to the patient and inform them of the SBT, stating they will turn off the ventilator machine and allow the patient to breathe independently. The respiratory therapist will switch off the ventilator and leave the room. The respiratory therapist and nurse will both be available throughout the SBT, and the ventilator will automatically turn on if the patient stops breathing. The SBT will last for 30-60 minutes.
Primary Outcome Measure Information:
Title
Proportion of successful initial spontaneous breathing trials (SBTs) vs failed initial SBTs
Description
A successful SBT is defined as when a patient sustains at least 30 minutes without mechanical ventilator support, as deemed by the respiratory therapist in the participant's chart.
A failed SBT is defined as when a patient requires mechanical ventilator support within 30 minutes of the start of the SBT, as deemed by the respiratory therapist.
Time Frame
Up to 48 hours after the participant's initial SBT.
Secondary Outcome Measure Information:
Title
Mean minutes sustained off ventilator support for failed SBTs
Description
Total minutes sustained off ventilator support, as noted by respiratory therapist in the participant's chart.
Time Frame
Up to 48 hours after the participant's initial SBT.
Title
Mean score of heart rate at points throughout SBT
Description
Recording of patient's heart rate via observation of monitor at three points throughout the SBT
Time Frame
At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT
Title
Mean score of respiratory rate at points throughout SBT
Description
Recording of patient's respiratory rate via observation of monitor at three points throughout the SBT
Time Frame
At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT
Title
Mean score of blood pressure at points throughout SBT
Description
Recording of patient's blood pressure via observation of monitor at three points throughout the SBT
Time Frame
At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT
Title
Mean score of agitation as assessed by the Richmond Agitation-Sedation Scale at points throughout SBT
Description
4 Combative- Overtly combative, violent, immediate danger to staff
3 Very agitated- Pulls or removes tube(s) or catheter(s); aggressive
2 Agitated- Frequent non-purposeful movement, fights ventilator
1 Restless- Anxious but movements not aggressive vigorous 0 Alert and calm
1 Drowsy- Not fully alert, but has sustained awakening (eye opening/contact) to voice (>10 seconds)
2 Light sedation- Briefly awakens with eye contact to voice (<10 seconds)
3 Moderate sedation- Movement or eye opening to voice (but no eye contact)
4 Deep sedation- No response to voice, but movement or eye opening to physical stimulation
5 Unarousable- No response to voice or physical stimulation
Time Frame
At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults 18+
Admitted to MUSC's Main Hospital medical intensive care unit (MICU) or Ashley River Tower medical-surgical intensive care unit (MSICU)
Intubated and will undergo a spontaneous breathing trial
Exclusion Criteria:
Patients who have had any prior SBTs
Patients known to have a neurological injury
Patients who are known to be deaf
Patients whom (or whose LAR) are unable or unwilling to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Macel Reising, MT-BC
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected individual participant data (IPD) may be shared with researchers at Appalachian State University where data analysis will occur, as the PI is currently a graduate student at that institution. Only de-identified data will go to App State; no protected health information (PHI) will leave Medical University of South Carolina (MUSC). De-identified data may be published as a master's thesis or in academic journals.
IPD Sharing Time Frame
Data sharing will become available during October 2021 and will occur until May 2022.
IPD Sharing Access Criteria
IPD will be shared with the PI's academic advisor for analysis of results with the purpose of writing a master's thesis paper.
Learn more about this trial
Feasibility of Music Therapy for Spontaneous Breathing Trials
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