Music's Effects on Anxiety During Epidural Placement

Sponsor
Medical University of South Carolina (Other)
Overall Status
Completed
CT.gov ID
NCT03844659
Collaborator
(none)
100
1
2
26.2
3.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Song "Weightless" by Marconi Union
  • Other: No Song
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Randomized Controlled Trial of Playing "The Most Relaxing Song in the World" During Labor Epidural Placement and Its Effects on Anxiety and Satisfaction
Actual Study Start Date :
Oct 19, 2018
Actual Primary Completion Date :
Dec 24, 2020
Actual Study Completion Date :
Dec 24, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Mean Score of Anxiety Before Epidural Placement [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.

  2. Mean Score of Anxiety After Epidural Placement [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425

Sponsors and Collaborators

  • Medical University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Gutman, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT03844659
Other Study ID Numbers:
  • 00078958
First Posted:
Feb 18, 2019
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022