Finding studies
Finding studies
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Lead
Brigham and Women's Hospital
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
