Music During Labor Epidural Placement and Patient Satisfaction

Satisfaction Clinical Trial

Official title:

Music During Labor Epidural Placement and Patient Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734056
• Other study ID #: 2015P001230
• Status: Completed
• Phase: N/A
• First received: March 30, 2016
• Last updated: April 6, 2016
• Start date: October 2015
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Satisfaction

Intervention

Other:
• Music
Listening to music that the patient likes
• Control
Control

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who reported higher patient satisfaction as measured by a patient satisfaction questionnaire	The questions will be scored and a composite score will be determined	1 hour	No