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Completed

NCT Number: NCT03844659

Music's Effects on Anxiety During Epidural Placement

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Mental Disorders Personal Satisfaction Satisfaction

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Song "Weightless" by Marconi Union

Other

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

Other

No song will be played during subjects labor epidural placement.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2019
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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