Music vs. No Music During Cesarean Delivery on Patient Satisfaction

Study Overview
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Brief Summary
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Several studies have demonstrated that music can improve various outcomes during labor and delivery. However, many of these studies didn't measure satisfaction rate accurately. This study aim to assess patient satisfaction in the setting of music or no music during the cesarean delivery. The study will be conducted in the labor and delivery unit and the expected number to enroll and complete the study is 22.

Detailed Description
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Background: Several studies have demonstrated that music can improve various outcomes during labor and delivery. In particular, patient satisfaction is often measured on a simple VAS scale, where 0 is no satisfaction and 10 is the highest satisfaction. However, patient satisfaction is a complex parameter to measure, and may be affected by a number of different factors. This study will be performed on the labor and delivery unit to assess patient satisfaction with a validated, reliable, 22-question survey in the setting of music or no music during the cesarean delivery. Although music is an all-encompassing term that describes sound with different pitches and rhythms that comes together as a harmonious whole, not all music is the same. Using music for therapeutic purposes would be the equivalent of using antibiotics to cure an infection; it is too general of a term, and unlikely that such a general use of music would show a valid therapeutic benefit. However, a study demonstrated that specific selections of Mozart piano sonatas, which have a specific rhythm and mode, improve patient anxiety through a biochemical mechanism (changing the plasma levels of IL-6 and epinephrine). Therefore, in this study, the term music will specifically means the same Mozart sonatas as described in the prior study. Objectives: The objective of this study is to determine the effect of music on patient satisfaction and anxiety during cesarean delivery. The hypothesis is that parturients exposed to music during cesarean delivery will have greater overall satisfaction and less anxiety. Study Timelines: Participation begins at the time of consultation for cesarean delivery on the day of surgery, where the co-investigator Dr. Dahlawi will approach the participants and ask them to sign the ICF, and it 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 two arms of the study are as follows: Control group: baseline hemodynamics and anxiety screen; no music Intervention group - Mozart: A study investigator will turn on a playlist of pre-selected Mozart music.

Official Title
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A Randomized Controlled Trial of Music vs. No Music During Cesarean Delivery on Patient Satisfaction

Conditions
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Patient Satisfaction

Intervention / Treatment
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* Other: Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-50 years old Scheduled for elective cesarean delivery Nulliparity Singleton pregnancy Full term fetus (≥37.0 weeks gestational age) Healthy fetus (no known congenital diseases at the time of surgery) Requesting neuraxial anesthesia for the procedure Able to provide informed consent Exclusion Criteria: Patient refusal Prior history of extensive abdominal surgery Active labor Contraindication to neuraxial anesthesia Uncorrected coagulopathy Infection at the skin site of epidural placement Increased intracranial pressure Untreated hemodynamic instability Known hypersensitivity to local anesthetics (a.k.a. amide or ester allergy) Patients with impaired hearing Patient on anti-anxiolytic medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be two arms of this randomized controlled trial as follows: Control group: baseline hemodynamics and anxiety screen; no music Intervention group - Mozart: A study investigator will turn on a playlist of pre-selected Mozart music.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>baseline hemodynamics and anxiety screen; no music. Satisfaction will be measured. | |
| Experimental: Intervention group - Mozart<br>A study investigator will turn on a playlist of pre-selected Mozart music. Hemodynamics and anxiety screen. Satisfaction will be measured. | Other: Music<br>* Selections of Mozart piano sonatas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | This outcome will be measured using Morgan's Maternal Satisfaction Scale for Cesarean Section (MSSCS). It is a 22-item questionnaire, each item have a Likert scale from 1-7 (1 =strongly disagree, 7=strongly agree), yielding a composite (total) score ranging 22-154, representing lowest to highest satisfaction. The questionnaire will be given to participants on post-operative day one during the hours of 8am-1pm. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Anxiety | Change in anxiety before and after surgery using a numeric rating scale from 0 (no anxiety at all) to 10 (greatest anxiety) | Perioperatively | 
| Hemodynamic Parameter (Mean Arterial Pressure, MAP) | This is the post-procedure mean arterial pressure of the patients. | post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music, Patient Satisfaction