Music's Effects on Anxiety During Epidural Placement

February 28, 2022 updated by: David Gutman, Medical University of South Carolina

A Randomized Controlled Trial of Playing "The Most Relaxing Song in the World" During Labor Epidural Placement and Its Effects on Anxiety and Satisfaction

The objective of the study is to determine if playing the song "Weightless" by Marconi Union during labor epidural placement, decreases laboring parturient anxiety and improves satisfaction with the experience.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • Females ages 18 years and older committed to delivery by the obstetrical team (natural labor or induction of labor)
  • English speaking
  • Able to give informed consent
  • Having an epidural placed Exclusion Criteria
  • Patient refusal
  • Intrauterine fetal demise
  • Imminent delivery
  • Existing music use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The song "Weightless" by Marconi Union will be playing during subjects labor epidural placement.
Other: Song "Weightless" by Marconi Union
Patients will be randomized to the intervention group (the song "Weightless" by Marconi Union will be playing) during subjects labor epidural placement. The intervention in this study is solely the addition of music.
Other: Non Intervention Group
No song will be played during subjects labor epidural placement.
Other: No Song
No song will be played during subjects labor epidural placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Score of Anxiety Before Epidural Placement
Time Frame: Immediately prior to procedure
3 different measures of anxiety prior to the procedure based on the State Trait Anxiety Inventory: 1) Numeric Rating Scale from 0-10 with 0 representing no anxiety and 10 representing worst anxiety possible. 2) Asking patient response to the question "Are you calm" with options scaling from "very much, moderately, somewhat, or not at all". 3) Asking the patient to answer the question "are you relaxed?" with options scaling from "very much, moderately, somewhat, or not at all." "Very much" will be treated as a positive finding and "moderately, somewhat, or not at all" as negative. The short form of the State Trait Anxiety Inventory with these three measures has been shown to be a reliable measure of anxiety. A fourth measure used will be a Visual Analog Scale from 0-100 of overall anxiety with 0 representing no anxiety and 100 representing the worst anxiety possible.
Immediately prior to procedure
Mean Score of Anxiety After Epidural Placement
Time Frame: Immediately after procedure
As soon as the epidural has been placed and appropriate documentation for the procedure is completed, both groups will take the same surveys again.
Immediately after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2018

Primary Completion (Actual)

December 24, 2020

Study Completion (Actual)

December 24, 2020

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00078958

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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