Music vs. No Music During Cesarean Delivery on Patient Satisfaction

• Sponsor: Tufts Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03412019
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.4
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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.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: Feb 21, 2018
• Actual Primary Completion Date: Aug 6, 2019
• Actual Study Completion Date: Aug 6, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patient Satisfaction [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 [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) [post procedure]

   This is the post-procedure mean arterial pressure of the patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts Medical Center

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 16, 2017

More Information

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.
• 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.

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT03412019
• Other Study ID Numbers: 12718
• First Posted: Jan 26, 2018
• Last Update Posted: Mar 3, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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

Study Results

Participant Flow

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	no music	Music: selections of Mozart piano sonatas
Period Title: Overall Study
STARTED	11	11
COMPLETED	10	10
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Control Group	Intervention Group	Total
Arm/Group Description	no music	Music: selections of Mozart piano sonatas	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.2 (4.2)	32.1 (6.1)	34.2 (5.5)
Sex: Female, Male (Count of Participants)
Female	10 100%	10 100%	20 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 10%	1 5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	6 60%	6 60%	12 60%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 40%	3 30%	7 35%

Outcome Measures

1. Primary Outcome

Title	Patient Satisfaction
Description	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.
Time Frame	1 Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	no music	Music: selections of Mozart piano sonatas
Measure Participants	10	10
Mean (Standard Deviation) [units on a scale]	120 (22.3)	116 (16.4)

2. Secondary Outcome

Title	Patient Anxiety
Description	Change in anxiety before and after surgery using a numeric rating scale from 0 (no anxiety at all) to 10 (greatest anxiety)
Time Frame	Perioperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	no music	Music: selections of Mozart piano sonatas
Measure Participants	10	10
Mean (Standard Deviation) [NRS scale (0-10)]	2.5 (2.6)	2.7 (2.7)

3. Secondary Outcome

Title	Hemodynamic Parameter (Mean Arterial Pressure, MAP)
Description	This is the post-procedure mean arterial pressure of the patients.
Time Frame	post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	no music	Music: selections of Mozart piano sonatas
Measure Participants	10	10
Mean (Standard Deviation) [mmHg]	82.2 (24.8)	80.4 (8.4)

Adverse Events

Time Frame	24 hours
Adverse Event Reporting Description	Adverse events would be tympanic membrane injury. Otherwise, would not differ from the data element definitions.
Arm/Group Title	Control Group		Intervention Group
Arm/Group Description	no music		Music: selections of Mozart piano sonatas
All Cause Mortality
	Control Group		Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Serious Adverse Events
	Control Group		Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Intervention Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.