Not provided
Not provided
Not provided
Not provided
Not provided
Study team decided to conclude the study and report it as a feasibility study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Therapy plus Standard Care | Experimental | Music therapy intervention in addition to standard hospital care during an SBT. |
|
| Standard Care | Active Comparator | Standard hospital care during an SBT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music therapy plus standard care during an SBT | Other | 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. |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Macel Reising, MT-BC | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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.
Data sharing will become available during October 2021 and will occur until May 2022.
IPD will be shared with the PI's academic advisor for analysis of results with the purpose of writing a master's thesis paper.
Not provided
Not provided
| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard care during an SBT | Procedure | 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. |
|
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 |
| At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |