Music During Labor Epidural Placement and Patient Satisfaction

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.

Study Overview

• Status: Completed
• Conditions: Satisfaction
• Intervention / Treatment: Other: Control; Other: Music

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02090
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music; The intervention to be administered is music	Other: Music; Listening to music that the patient likes
Experimental: Control; There is no intervention listed here because this is the control group, in which there will be no intervention.	Other: Control; Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2015P001230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will publish in a medical journal