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Music vs. No Music During Cesarean Delivery on Patient Satisfaction

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ClinicalTrials.gov Identifier: NCT03412019
Recruitment Status : Completed
First Posted : January 26, 2018
Results First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patient Satisfaction Other: Music Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Music vs. No Music During Cesarean Delivery on Patient Satisfaction
Actual Study Start Date : February 21, 2018
Actual Primary Completion Date : August 6, 2019
Actual Study Completion Date : August 6, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 1 Day ]

    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.



Secondary Outcome Measures :
  1. Patient Anxiety [ Time Frame: Perioperatively ]
    Change in anxiety before and after surgery using a numeric rating scale from 0 (no anxiety at all) to 10 (greatest anxiety)

  2. Hemodynamic Parameter (Mean Arterial Pressure, MAP) [ Time Frame: post procedure ]
    This is the post-procedure mean arterial pressure of the patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412019


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Dan Drzymalski, MD Tufts Medical Center
  Study Documents (Full-Text)

Documents provided by Tufts Medical Center:
Publications:
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03412019    
Other Study ID Numbers: 12718
First Posted: January 26, 2018    Key Record Dates
Results First Posted: March 3, 2020
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will be shared upon reasonable request.
Supporting Materials: Study Protocol
Time Frame: Available for 1 year within publication.
Access Criteria: Will need to write a formal request with reason for need to access the data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tufts Medical Center:
Music
Patient Satisfaction