Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT02732964
The aim of this study is to evaluate the effect of perioperative music on maternal anxiety, hemodynamic response to spinal anesthesia, postoperative pain medication requirement, and overall maternal satisfaction.
Investigators hypothesize that women exposed to perioperative music will have greater overall satisfaction with the delivery experience. Investigators also hypothesize that perioperative music will lower anxiety levels of women having a scheduled cesarean delivery, result in a less profound degree of spinal-induced hypotension prior to cesarean delivery, and result in a lower requirement of analgesics postpartum.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients enrolled will be exposed to Pandora music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.
Patients enrolled will be exposed to Mozart music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.
Time frame: prior to surgery
assessed by VAS questionnaire
Time frame: 30 minutes after surgery
assessed by VAS questionnaire
Time frame: within 30 minutes of spinal placement
nadir systolic arterial pressure within 30 minutes of spinal placement
Time frame: prior to surgery
assessed by STAI questionnaire
Time frame: 30 minutes after surgery
assessed by STAI questionnaire
Time frame: prior to surgery
Assessed by questionnaire on postop day 1
Time frame: 30 minutes after surgery
Assessed by questionnaire on postop day 1
Time frame: postoperative day 1
Assessed by questionnaire on postop day 1
Time frame: prior to surgery
Assessed by pain control/analgesic requirement on postop day 1
Time frame: 30 minutes after surgery
Assessed by pain control/analgesic requirement on postop day 1
Time frame: postoperative day 1
Assessed by pain control/analgesic requirement on postop day 1
Time frame: within 30 minutes of spinal placement
utilization of phenylephrine, micrograms
Time frame: within 30 minutes of spinal placement
utilization of ephedrine, milligrams
Brigham and Women's Hospital
Other
Perioperative Music for Patients Undergoing Scheduled Cesarean Delivery: Impact on Satisfaction, Anxiety, and Hemodynamic Response to Spinal Anesthesia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06608550
Anxiety, Anxiety Disorders
Mersin, Turkey (Türkiye)
View Trial DetailsNCT04070183
Anxiety, Anxiety Disorders
Indianapolis, Indiana, United States
View Trial DetailsNCT06936540
Anxiety, Anxiety Disorders
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07097636
Anxiety, Anxiety Disorders
Bursa, Turkey (Türkiye)
View Trial Details