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Music During Labor Epidural Placement and Patient Satisfaction

Music During Labor Epidural Placement and Patient Satisfaction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02734056
Enrollment
100
Registered
2016-04-12
Start date
2015-10-31
Completion date
2016-01-31
Last updated
2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Satisfaction

Brief summary

Patient satisfaction is becoming increasingly important to hospital administrators as a metric for quality of patient care services because it is now being linked to reimbursements (Maher 2015). Patient satisfaction is a complex problem, and may be affected by a variety of factors. A recent study found that higher patient satisfaction was associated with patients who received music therapy during their hospital stay (Mandel 2014). Given that music may positively affect patient satisfaction, we are designing a study to examine the effects of patient-preferred music on patient satisfaction in women undergoing labor epidural placement.

Detailed description

PROCEDURES STEP-BY-STEP 1. Once enrolled in the study, patient will be randomized to either: * The intervention group (music played on a portable speaker system), or * The control group (no music). 2. Prior to epidural placement, patients in both groups will be asked to answer one question about their music preference: What is your favorite music? You can name an artist, genre, album, or any other identifier • If patient preferred music is not available on the Pandora app, other apps will be searched (Spotify, Youtube, itunes Radio, etc.) 3. If patients are randomized to the intervention group, the investigator will create a station in the Pandora music app using the patient's preferred music. Volume will be initially set on low and portable speaker system placed within 3 feet of the patient (in order to ensure that she can hear the music). The music will be started and volume will then be adjusted to the patient's preference, avoiding music that is too loud but ensuring it is loud enough so the patient can hear it. 4. At that point, epidural placement will begin. Patients will receive an epidural in the normal fashion. Music will be continued throughout the duration of the epidural placement procedure, unless the patient requests that it be discontinued earlier. 5. If patients are randomized to the control group, no music will be played. 6. One hour after epidural placement, the patient will be asked to fill out the patient satisfaction survey to assess their satisfaction with the epidural placement. All patients from both the intervention and control group will be asked to complete the survey. 7. Data (see below) will be collected from the chart at time of enrollment and at time of study completion.

Interventions

OTHERMusic

Listening to music that the patient likes

OTHERControl

Control

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

No masking was possible.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

1. Pregnant women in labor • Healthy pregnant women in labor requesting epidural labor analgesia 2. \>30 weeks gestation 3. Ages 18 - 45

Exclusion criteria

1. Any patient who refuses 2. Women with impaired decision-making capacity 3. Patients who are deaf or extremely hard of hearing (if patients wear a hearing aid and can hear with it, then patients are still eligible to be in the study)

Design outcomes

Primary

MeasureTime frameDescription
Anxiety1 hourThe 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.

Countries

United States

Participant flow

Recruitment details

Patients were consented prior to recruitment

Participants by arm

ArmCount
Music
The intervention to be administered is music Music: Listening to music that the patient likes
50
Control
There is no intervention listed here because this is the control group, in which there will be no intervention. Control: Control
50
Total100

Baseline characteristics

CharacteristicControlTotalMusic
Age, Continuous32 years
STANDARD_DEVIATION 6
32 years
STANDARD_DEVIATION 6
31 years
STANDARD_DEVIATION 6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
6 Participants13 Participants7 Participants
Race (NIH/OMB)
Black or African American
3 Participants13 Participants10 Participants
Race (NIH/OMB)
More than one race
13 Participants23 Participants10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
28 Participants51 Participants23 Participants
Sex: Female, Male
Female
50 Participants100 Participants50 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 500 / 50
other
Total, other adverse events
0 / 500 / 50
serious
Total, serious adverse events
0 / 500 / 50

Outcome results

Primary

Anxiety

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.

Time frame: 1 hour

ArmMeasureValue (MEAN)Dispersion
MusicAnxiety2.9 NRSStandard Deviation 3.3
ControlAnxiety1.4 NRSStandard Deviation 1.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026