Impact of Music on Satisfaction, Anxiety, and Hemodynamics During Spinal Anesthesia for Cesarean Delivery

Several studies have demonstrated that preoperative anxiety has been associated with more
profound hypotension after spinal anesthesia for cesarean delivery. Music has been shown to
have a positive impact on hemodynamic response and patient satisfaction.

To investigators knowledge, however, no studies have evaluated the effects of music during
the perioperative period for cesarean delivery on patient satisfaction and hemodynamic
responses.

The study will be conducted as a randomized unblended controlled trial with three study arms:
control (no music), intervention - Pandora® (patient selected music), and intervention -
Mozart (pre-selected relaxing music). Eligibility criteria include pregnant women, 18 years
or older, scheduled for elective cesarean delivery under spinal anesthesia. Exclusion
criteria include absolute contraindications of neuraxial anesthesia including patient
refusal, uncorrected coagulopathy, infection at the skin site of epidural placement,
increased intracranial pressure, or untreated hemodynamic instability. Patients in active
labor, with impaired hearing, or who do not want to participate in the study will also be
excluded. All subjects will be recruited from women admitted for scheduled cesarean delivery
at Brigham and Women's Hospital. Investigators anticipate enrolling 150 patients, with 50
patients in each arm of the study.

Participation begins at the time of consultation on the day of surgery, and ends after the
post-anesthesia check on postoperative day 1. After recruitment and consent, patients will be
randomized using a computer-generated randomization scheme will be used to allocate patients
to one of the arms of the study.

The three arms of the study are as follows:

1. Control group: baseline hemodynamics and anxiety screen; no music

2. Intervention group - Pandora: A study investigator will create a station in the Pandora®
music application based on the patient's preferred music genre or artist.

3. Intervention group - Mozart: A study investigator will turn on a playlist of
pre-selected Mozart music.

At the time of recruitment, patient demographic data and vitals signs will be collected. A
baseline anxiety screen will be obtained (all groups) using the verbal analog scale (VAS)
anxiety score and abbreviated State-Trait Anxiety Inventory (STAI) questionnaire. Thirty
minutes prior to spinal anesthesia for cesarean delivery the designated music group will have
music initiated, as described above. 30 minutes after completion of spinal placement, patient
hemodynamics and vasopressor requirement (phenylephrine, ephedrine) will be evaluated by the
co-investigator in 5 minute intervals. Thirty minutes after arrival in the post-anesthesia
care unit postpartum, a postpartum anxiety screen will be obtained (all groups) using the VAS
and STAI questionnaire. On postpartum day 1, all patients enrolled in this study will be
evaluated within 24 hours of the spinal anesthetic.

Inclusion Criteria:

- pregnant women

- 8 years or older

- scheduled for elective cesarean delivery under spinal anesthesia.

Exclusion Criteria:

- absolute contraindications of neuraxial anesthesia including patient refusal

- uncorrected coagulopathy

- infection at the skin site of epidural placement

- increased intracranial pressure, or untreated hemodynamic instability.

- Patients in active labor, with impaired hearing, or who do not want to participate in
the study will also be excluded.