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

Study Overview
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Brief Summary
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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.

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

Official Title
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Perioperative Music for Patients Undergoing Scheduled Cesarean Delivery: Impact on Satisfaction, Anxiety, and Hemodynamic Response to Spinal Anesthesia

Conditions
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Anxiety, Hypotension

Intervention / Treatment
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* Other: Pandora Music
* Other: Mozart Music


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>baseline hemodynamics and anxiety screen; no music | |
| Experimental: Pandora Music<br>A study investigator will create a station in the Pandora® music application based on the patient's preferred music genre or artist. | Other: Pandora Music<br>* Patients enrolled will be exposed to Pandora music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.<br>|
| Experimental: Mozart Music<br>A study investigator will turn on a playlist of pre-selected Mozart music. | Other: Mozart Music<br>* Patients enrolled will be exposed to Mozart music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal anxiety level, VAS | assessed by VAS questionnaire | prior to surgery | 
| maternal anxiety level, VAS | assessed by VAS questionnaire | 30 minutes after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maternal blood pressure after spinal anesthesia induction , compared to baseline blood pressure | nadir systolic arterial pressure within 30 minutes of spinal placement | within 30 minutes of spinal placement | 
| maternal anxiety level, STAI | assessed by STAI questionnaire | prior to surgery | 
| maternal anxiety level, STAI | assessed by STAI questionnaire | 30 minutes after surgery | 
| Overall patient satisfaction, questionnaire | Assessed by questionnaire on postop day 1 | prior to surgery | 
| Overall patient satisfaction, questionnaire | Assessed by questionnaire on postop day 1 | 30 minutes after surgery | 
| Overall patient satisfaction, questionnaire | Assessed by questionnaire on postop day 1 | postoperative day 1 | 
| Overall patient satisfaction, pain control | Assessed by pain control/analgesic requirement on postop day 1 | prior to surgery | 
| Overall patient satisfaction, pain control | Assessed by pain control/analgesic requirement on postop day 1 | 30 minutes after surgery | 
| Overall patient satisfaction, pain control | Assessed by pain control/analgesic requirement on postop day 1 | postoperative day 1 | 
| Vasopressor requirement, phenylephrine | utilization of phenylephrine, micrograms | within 30 minutes of spinal placement | 
| Vasopressor requirement, ephedrine | utilization of ephedrine, milligrams | within 30 minutes of spinal placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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satisfaction