Music vs. No Music During Cesarean Delivery on Patient Satisfaction

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

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.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: Music

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Investigators: Principal Investigator: Dan Drzymalski, MD, Tufts Medical Center

Publications and helpful links

General Publications

• Conrad C, Niess H, Jauch KW, Bruns CJ, Hartl W, Welker L. Overture for growth hormone: requiem for interleukin-6? Crit Care Med. 2007 Dec;35(12):2709-13. doi: 10.1097/01.ccm.0000291648.99043.b9.
• Morgan PJ, Halpern S, Lo J. The development of a maternal satisfaction scale for caesarean section. Int J Obstet Anesth. 1999 Jul;8(3):165-70. doi: 10.1016/s0959-289x(99)80132-0.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 21, 2018
• Primary Completion (ACTUAL): August 6, 2019
• Study Completion (ACTUAL): August 6, 2019

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (ACTUAL): January 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Music; Patient Satisfaction
• Other Study ID Numbers: 12718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will be shared upon reasonable request.
• IPD Sharing Time Frame: Available for 1 year within publication.
• IPD Sharing Access Criteria: Will need to write a formal request with reason for need to access the data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No