Medical Use of Song In Critical Care (MUSIC)

Music therapy has been applied in a variety of clinical settings to reduce stress, provide a
distraction for patients from unpleasant procedures or symptoms, and improve the overall
atmosphere and general comfort of patients.

In a preliminary study, investigators have found that subjects experience symptoms of
anxiety and stress. It is the investigators hope that providing music as an intervention
will alter subjects' recollections of their time in the ICU and creates a more positive ICU
experience.

The investigator aims to provide the music intervention, receive full questionnaire
completion and recall of subjects' experiences from a total of 40 subjects. Some subjects,
however, will not have recall of either the ICU or mechanical ventilation and, therefore, it
is predicted that it will require enrolling approximately 75 subjects to reach this goal.

The music intervention will begin after surrogate consent is obtained. Each day while
mechanically ventilated, the subject will receive a morning and an afternoon music session
lasting one hour. If available, single subject use, disposable headphones may be utilized,
or music may be played directly through the computer speakers. Music sessions will occur
each day while the subject is mechanically ventilated or up to seven consecutive days.
During each music session, study staff will complete a clinical assessment(consisting of
vital signs, ventilation data and medications) at three time points during each music
session. It is anticipated that some subjects may only have 1 music session per day, or have
to skip a day due to clinical condition. If a subject is only able to have one music session
on a specific day or a day is missed, a subject will not be considered withdrawn from the
study or ineligible for further participation. This will be recorded on the source
documents, and the total number of music sessions will be analyzed during analysis. In
addition, study staff will not preclude additional music sessions if requested by
surrogates. This will also be documented in the source documents by study staff.

Subjects that receive any music sessions during mechanical ventilation will be approached
after their discharge from the ICU and before discharge from the hospital. At this point in
the study, subjects will be asked to sign the consent form themselves, indicating that they
agree to continue with the study and complete the questionnaires. The Mini Mental Status
Exam will be done to assess capacity to complete the ICU Stressful Experiences
Questionnaire. A score of 25 or higher will be used as a marker to determine if a subject
will be administered the questionnaire as was done in the prior study. If potential
candidates are deemed to have capacity they will be administered the 32-item, previously
validated, ICU Stressful Experiences Questionnaire with the addition of a few questions
specific to their recall and experience with the music while critically ill. If a subject
receives music sessions, but is not able to provide consent for the questionnaires (due to
clinical limitations or hospital discharge) they will not be excluded from the study. A
limited data set will be utilized for these subjects.

After the questionnaire has been administered, medical record data will be abstracted from
the chart.

Inclusion Criteria:

- Adult patients ≥ 18 yrs of age

- Admitted to Medical Intensive Care Unit (MICU) (3B and 3C) or Surgical Intensive Care
Unit (SICU) (8C, 8D, 11C)

- Expected to receive mechanical ventilation ≥ 24hr

- Surrogate present to provide informed consent

Exclusion Criteria:

- Intubated at a transferring hospital for > 24 hr before arrival to Brigham and
Women's Hospital (BWH)

- Chronically ventilator dependent before admission to the hospital

- Transplant candidate or recipient

- Non-English speaking as the questionnaire has not been translated

- Prisoner