Trial Outcomes & Findings for Music vs. No Music During Cesarean Delivery on Patient Satisfaction (NCT NCT03412019)

NCT ID: NCT03412019

Last Updated: 2020-03-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

1 Day

Results posted on

2020-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group no music	Intervention Group Music: selections of Mozart piano sonatas
Overall Study STARTED	11	11
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group no music	Intervention Group Music: selections of Mozart piano sonatas
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Patients decided to withdraw from the study prematurely

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=10 Participants no music	Intervention Group n=10 Participants Music: selections of Mozart piano sonatas	Total n=20 Participants Total of all reporting groups
Age, Continuous	36.2 years STANDARD_DEVIATION 4.2 • n=39 Participants • Patients decided to withdraw from the study prematurely	32.1 years STANDARD_DEVIATION 6.1 • n=41 Participants • Patients decided to withdraw from the study prematurely	34.2 years STANDARD_DEVIATION 5.5 • n=35 Participants • Patients decided to withdraw from the study prematurely
Sex: Female, Male Female	10 Participants n=39 Participants • patients who were not anlayzed withdrew from the study	10 Participants n=41 Participants • patients who were not anlayzed withdrew from the study	20 Participants n=35 Participants • patients who were not anlayzed withdrew from the study
Sex: Female, Male Male	0 Participants n=39 Participants • patients who were not anlayzed withdrew from the study	0 Participants n=41 Participants • patients who were not anlayzed withdrew from the study	0 Participants n=35 Participants • patients who were not anlayzed withdrew from the study
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants • those who withdrew early were not analyzed	0 Participants n=41 Participants • those who withdrew early were not analyzed	0 Participants n=35 Participants • those who withdrew early were not analyzed
Race (NIH/OMB) Asian	0 Participants n=39 Participants • those who withdrew early were not analyzed	1 Participants n=41 Participants • those who withdrew early were not analyzed	1 Participants n=35 Participants • those who withdrew early were not analyzed
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants • those who withdrew early were not analyzed	0 Participants n=41 Participants • those who withdrew early were not analyzed	0 Participants n=35 Participants • those who withdrew early were not analyzed
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants • those who withdrew early were not analyzed	0 Participants n=41 Participants • those who withdrew early were not analyzed	0 Participants n=35 Participants • those who withdrew early were not analyzed
Race (NIH/OMB) White	6 Participants n=39 Participants • those who withdrew early were not analyzed	6 Participants n=41 Participants • those who withdrew early were not analyzed	12 Participants n=35 Participants • those who withdrew early were not analyzed
Race (NIH/OMB) More than one race	0 Participants n=39 Participants • those who withdrew early were not analyzed	0 Participants n=41 Participants • those who withdrew early were not analyzed	0 Participants n=35 Participants • those who withdrew early were not analyzed
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=39 Participants • those who withdrew early were not analyzed	3 Participants n=41 Participants • those who withdrew early were not analyzed	7 Participants n=35 Participants • those who withdrew early were not analyzed

PRIMARY outcome

Timeframe: 1 Day

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants no music	Intervention Group n=10 Participants Music: selections of Mozart piano sonatas
Patient Satisfaction	120 units on a scale Standard Deviation 22.3	116 units on a scale Standard Deviation 16.4

SECONDARY outcome

Timeframe: Perioperatively

Change in anxiety before and after surgery using a numeric rating scale from 0 (no anxiety at all) to 10 (greatest anxiety)

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants no music	Intervention Group n=10 Participants Music: selections of Mozart piano sonatas
Patient Anxiety	2.5 NRS scale (0-10) Standard Deviation 2.6	2.7 NRS scale (0-10) Standard Deviation 2.7

SECONDARY outcome

Timeframe: post procedure

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

Outcome measures

Outcome measures
Measure	Control Group n=10 Participants no music	Intervention Group n=10 Participants Music: selections of Mozart piano sonatas
Hemodynamic Parameter (Mean Arterial Pressure, MAP)	82.2 mmHg Standard Deviation 24.8	80.4 mmHg Standard Deviation 8.4

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dan Drzymalski, MD

Tufts Medical Center

Phone: 617 636 4526

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place