Spontaneous Breathing TrialNCT05008328
Feasibility of Music Therapy for Spontaneous Breathing Trials
A study of Spontaneous Breathing Trial and Intubation, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Breathing Trial, Intubation, Mechanical Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
- Being tested
- Music therapy plus standard care during an SBT, Standard care during an SBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy plus standard care during an SBTOther
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.
Standard care during an SBTProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy plus Standard Care | Experimental | Music therapy intervention in addition to standard hospital care during an SBT. Receives: Other: Music therapy plus standard care during an SBT |
| Standard Care | Active comparator | Standard hospital care during an SBT. Receives: Procedure: Standard care during an SBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 48 hours after the participant's initial SBT.
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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 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
Measured: At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start30 Aug 2021
- Primary completion31 Oct 2022
- Study completion1 Jan 2023
Why it stopped: Study team decided to conclude the study and report it as a feasibility study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Breathing TrialStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Macel Reising, MT-BC, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008328
- Sponsor's protocol ID
- Pro00110030
- Status last verified
- Oct 2024
- First submitted
- 28 Jul 2021
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Live, Receptive Music Therapy for Patients Undergoing Spontaneous Breathing Trials: a Pilot Study
- ClinicalTrials.gov ID
- NCT05008328
- Acronym / sponsor ID
- Pro00110030
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study team decided to conclude the study and report it as a feasibility study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy plus Standard Care | Experimental | Other: Music therapy plus standard care during an SBTMusic therapy intervention in addition to standard hospital care during an SBT. |
| Standard Care | Active comparator | Procedure: Standard care during an SBTStandard hospital care during an SBT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapy plus standard care during an SBTIf 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. | Other | Music Therapy plus Standard Care |
| Standard care during an SBTThe 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. | Procedure or surgery | Standard Care |
Primary outcome
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.
5 secondary outcomes
Mean minutes sustained off ventilator support for failed SBTs
Time frame: 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
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
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
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
Results and safety
The study was stopped early (reason given: Study team decided to conclude the study and report it as a feasibility study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Macel Reising, MT-BC principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Spontaneous Breathing Trial and Intubation, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study team decided to conclude the study and report it as a feasibility study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of successful initial spontaneous breathing trials (SBTs) vs failed initial SBTs (time frame: Up to 48 hours after the participant's initial SBT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.