Music's Effects on Anxiety During Epidural Placement

NCT03844659 | Completed

• 1 other identifier: 00078958
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

The song "Weightless" by Marconi Union will be playing during subjects labor epidural placement.

Other: Song "Weightless" by Marconi Union

Non Intervention Group

OTHER

No song will be played during subjects labor epidural placement.

Other: No Song

Interventions

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.

Intervention Group

No Song OTHER

No song will be played during subjects labor epidural placement.

Non Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient refusal
• Intrauterine fetal demise
• Imminent delivery
• Existing music use

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: October 19, 2018
• Primary Completion: December 24, 2020
• Study Completion: December 24, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)