Clinical trial NCT05008328: Feasibility of Music Therapy for Spontaneous Breathing Trials
Official title: Feasibility of Live, Receptive Music Therapy for Patients Undergoing Spontaneous Breathing Trials: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spontaneous Breathing Trial
Intubation
Mechanical Ventilation
Music Therapy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of successful initial spontaneous breathing trials (SBTs) vs failed initial SBTs
timeFrame: Up to 48 hours after the participant's initial SBT.
Secondary outcomes:
measure: Mean minutes sustained off ventilator support for failed SBTs
timeFrame: Up to 48 hours after the participant's initial SBT.
measure: Mean score of heart rate at points throughout SBT
timeFrame: At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT
measure: Mean score of respiratory rate at points throughout SBT
timeFrame: At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT
measure: Mean score of blood pressure at points throughout SBT
timeFrame: At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT
measure: Mean score of agitation as assessed by the Richmond Agitation-Sedation Scale at points throughout SBT
timeFrame: At minute 0 of the SBT, 10 minutes into the SBT, and 30 minutes into the SBT
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Macel Reising, MT-BC
role: PRINCIPAL_INVESTIGATOR
References: