Music During Labor Epidural Placement and Patient Satisfaction

NCT ID: NCT02734056

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-01-31

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.

Conditions

Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Music

The intervention to be administered is music

Group Type: EXPERIMENTAL

Music

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Control

Intervention Type: OTHER

Control

Interventions

Music

Listening to music that the patient likes

Intervention Type: OTHER

Control

Control

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bhavani Shankar Kodali

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bhavani Kodali, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2015P001230

Identifier Type: -

Identifier Source: org_study_id