Music During Labor Epidural Placement and Patient Satisfaction

NCT02734056 | Completed Results

• 1 other identifier: 2015P001230
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Music

EXPERIMENTAL

The intervention to be administered is music

Other: Music

Control

EXPERIMENTAL

There is no intervention listed here because this is the control group, in which there will be no intervention.

Other: Control

Interventions

Music OTHER

Listening to music that the patient likes

Music

Control OTHER

Control

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Any patient who refuses
• Women with impaired decision-making capacity
• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02090, United States

Location

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Bhavani Kodali
• Organization: Brigham

kodali@zeus.bwh.harvard.edu

6175258449

Study Officials

• Bhavani Kodali, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 12, 2016
• Study Start: October 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 30, 2017
• Results First Posted: March 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)