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
|Condition or disease||Intervention/treatment||Phase|
|Patient Satisfaction||Other: Music||Not Applicable|
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.
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.
- 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 (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
There will be two arms of this randomized controlled trial as follows:
|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|
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.
Selections of Mozart piano sonatas
- 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.
- 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)
- Hemodynamic Parameter (Mean Arterial Pressure, MAP) [ Time Frame: post procedure ]This is the post-procedure mean arterial pressure of the patients.
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
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Dan Drzymalski, MD||Tufts Medical Center|