Feasibility of Music Therapy for Spontaneous Breathing Trials

October 22, 2024 updated by: Medical University of South Carolina

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of successful initial spontaneous breathing trials (SBTs) vs failed initial SBTs
Time Frame: Up to 48 hours after the participant's initial SBT.

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean minutes sustained off ventilator support for failed SBTs
Time Frame: Up to 48 hours after the participant's initial SBT.
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
Time Frame: At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the 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
Time Frame: At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the 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
Time Frame: At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the 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
Time Frame: At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the 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
At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Macel Reising, MT-BC, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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
  • SAP
  • 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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