Clinical trial NCT03412019: Music vs. No Music During Cesarean Delivery on Patient Satisfaction
Official title: A Randomized Controlled Trial of Music vs. No Music During Cesarean Delivery on Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Keywords: Music
Patient Satisfaction
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 1 Day
Secondary outcomes:
measure: Patient Anxiety
timeFrame: Perioperatively
measure: Hemodynamic Parameter (Mean Arterial Pressure, MAP)
timeFrame: post procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Dan Drzymalski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.