Anxiety Self-Management for ICU Patients Receiving Mechanical Ventilation

A three group randomized trial with repeated measures. Participants are assigned by chance
to one of three groups: 1) patient-directed, as desired music listening through headphones,
2) noise-canceling headphones only, or 3) usual care. Participants remain in the study, up
to 30 days, as long as they are receiving mechanical ventilation in the ICU, choose to
withdraw, or become unable to complete the daily anxiety assessments. Information is
collected daily on patient-perceived anxiety levels (visual analog scale & State Anxiety
Inventory), ventilator settings, and all medications received. Urine is collected each day
the participant is on the ventilator to determine level of stress (cortisol) if the kidneys
are functioning appropriately and the participant is not receiving medications known to
influence cortisol levels.

Mechanical ventilation is a common treatment for respiratory problems for patients in the
ICU. Patients receiving mechanical ventilation experience much anxiety and distress from the
placement of the endotracheal tube (breathing tube) and the mechanical ventilator itself.
The usual treatment for these symptoms are medications, which are very potent and have
numerous adverse side effects, removing patient involvement and control from managing these
symptoms. Music has been shown to decrease anxiety and promote relaxation in limited, single
listening intervention studies with patients in the ICU on ventilators. This study tests
whether having patients listen to preferred music (familiar & comforting) whenever feeling
anxious and wanting to relax for as long as they would like to listen to music through
headphones throughout the entire time they are on the ventilator can improve outcomes such
as less anxiety, shorter time on the ventilator, receipt of fewer medications, and less
stress when compared to patients who do not listen to music while they are on the
ventilator. Results from this study will advance nursing science by providing evidence on
the efficacy of a simple, self-directed intervention that the millions of patients who
receive mechanical ventilation each year in the ICU can use themselves to treat the very
common symptoms of anxiety and distress. Results from this study will expand the knowledge
base of adjunctive interventions that can be implemented in the ICU to involve patients
directly in managing their own symptoms, ultimately improving patient outcomes.

Patients who are alert and can provide consent are invited to participate if they are on the
ventilator in one of the participating ICUs. Patients remain in the study for as long as
they are on the ventilator (up to 30 days) and can provide daily assessment of their anxiety
levels. Patients are free to withdraw, however, at any time. Patients randomized to music
receive an assessment of their music preferences by a professional music therapist. The
music therapist then develops a music collection for each participant, based in individual
preferences, that is kept at the bedside throughout the duration of being on the ventilator.
The music therapist also visits with music participants' daily to determine if preferences
have changed and if he/she desires additional music CDs to be kept at the bedside. Data is
collected from the medical record on all medications and ventilator settings each day the
participant is enrolled in the study. All urine is collected each day the participant
remains in the study if the kidneys are functioning properly and the participant is not
receiving medications known to influence cortisol, a marker for an integrative level of
stress.

Inclusion Criteria:

- Any patient who is alert, on the ventilator because there is some condition involving
the lungs preventing him/her from breathing on his/her own and willing and able to
provide own consent.

Exclusion Criteria:

- On the ventilator because of a surgical procedure, not alert and unable to provide
own consent.