Feasibility of Music Therapy for Spontaneous Breathing Trials

NCT05008328 | Terminated

• 1 other identifier: Pro00110030
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Spontaneous Breathing Trial; Intubation; Mechanical Ventilation; Music Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mean minutes sustained off ventilator support for failed SBTs

  Up to 48 hours after the participant's initial SBT.

• Mean score of heart rate at points throughout 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

  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

  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

Study Arms (2)

Music Therapy plus Standard Care

EXPERIMENTAL

Music therapy intervention in addition to standard hospital care during an SBT.

Other: Music therapy plus standard care during an SBT

Standard Care

ACTIVE COMPARATOR

Standard hospital care during an SBT.

Procedure: Standard care during an SBT

Interventions

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.

Music Therapy plus Standard Care

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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Macel Reising, MT-BC

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 17, 2021
• Study Start: August 30, 2021
• Primary Completion: October 31, 2022
• Study Completion: January 1, 2023
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data sharing will become available during October 2021 and will occur until May 2022.
• 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.

Locations

US (1)