Feasibility of Music Therapy for Spontaneous Breathing Trials

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05008328
• Other study ID #: Pro00110030
• Status: Terminated
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 1, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intubation
• Mechanical Ventilation
• Music Therapy
• Respiratory Aspiration
• Spontaneous Breathing Trial

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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	At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT