Feasibility of Music Therapy for Spontaneous Breathing Trials

Feasibility of Live, Receptive Music Therapy for Patients Undergoing Spontaneous Breathing Trials: A Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Intubation; Mechanical Ventilation; Music Therapy; Spontaneous Breathing Trial
• Intervention / Treatment: Other: Music therapy plus standard care during an SBT; Procedure: Standard care during an SBT

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music Therapy plus Standard Care; Music therapy intervention in addition to standard hospital care during an SBT.	Other: Music therapy plus standard care during an SBT; 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.
Active Comparator: Standard Care; Standard hospital care during an SBT.	Procedure: Standard care during an SBT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 48 hours after the participant's initial SBT.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 48 hours after the participant's initial SBT.
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	At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into 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	At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into 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	At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into 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 calm1 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 stimulation5 Unarousable- No response to voice or physical stimulation	At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Macel Reising, MT-BC, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: Pro00110030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No