Music's Effects on Anxiety During Epidural Placement

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844659
• Other study ID #: 00078958
• Status: Completed
• Phase: N/A
• Start date: October 19, 2018
• Est. completion date: December 24, 2020

Study information

• Verified date: February 2022
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 24, 2020
• Est. primary completion date: December 24, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Satisfaction

Intervention

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.
• No Song
No song will be played during subjects labor epidural placement.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Score of Anxiety Before Epidural Placement	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
Primary	Mean Score of Anxiety After Epidural Placement	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