Trial Outcomes & Findings for Music During Labor Epidural Placement and Patient Satisfaction (NCT NCT02734056)

Last Updated: 2017-03-30

Results Overview

The questions will be scored and a composite score will be determined. The scale is the numeric rating score, from 0-10, where 0 represents no anxiety and 10 represents the worst anxiety. Unit of measure is score on a scale.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

1 hour

Results posted on

2017-03-30

Participant Flow

Patients were consented prior to recruitment

Participant milestones

Participant milestones
Measure	Music The intervention to be administered is music Music: Listening to music that the patient likes	Control There is no intervention listed here because this is the control group, in which there will be no intervention. Control: Control
Overall Study STARTED	50	50
Overall Study COMPLETED	50	49
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Music During Labor Epidural Placement and Patient Satisfaction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Music n=50 Participants The intervention to be administered is music Music: Listening to music that the patient likes	Control n=50 Participants There is no intervention listed here because this is the control group, in which there will be no intervention. Control: Control	Total n=100 Participants Total of all reporting groups
Age, Continuous	31 years STANDARD_DEVIATION 6 • n=5 Participants	32 years STANDARD_DEVIATION 6 • n=7 Participants	32 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	28 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Outcome measures

Outcome measures
Measure	Music n=50 Participants The intervention to be administered is music Music: Listening to music that the patient likes	Control n=49 Participants There is no intervention listed here because this is the control group, in which there will be no intervention. Control: Control
Anxiety	2.9 NRS Standard Deviation 3.3	1.4 NRS Standard Deviation 1.7

Adverse Events

Music

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Bhavani Kodali

Brigham

Phone: 6175258449

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place