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Music's Effects on Anxiety During Epidural Placement

Primary Purpose

Anxiety, Satisfaction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Song "Weightless" by Marconi Union
No Song
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Non Intervention Group

Arm Description

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

No song will be played during subjects labor epidural placement.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2019
Last Updated
February 28, 2022
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03844659
Brief Title
Music's Effects on Anxiety During Epidural Placement
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
December 24, 2020 (Actual)
Study Completion Date
December 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The song "Weightless" by Marconi Union will be playing during subjects labor epidural placement.
Arm Title
Non Intervention Group
Arm Type
Other
Arm Description
No song will be played during subjects labor epidural placement.
Intervention Type
Other
Intervention Name(s)
Song "Weightless" by Marconi Union
Intervention Description
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 Type
Other
Intervention Name(s)
No Song
Intervention Description
No song will be played during subjects labor epidural placement.
Primary Outcome Measure Information:
Title
Mean Score of Anxiety Before Epidural Placement
Description
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.
Time Frame
Immediately prior to procedure
Title
Mean Score of Anxiety After Epidural Placement
Description
As soon as the epidural has been placed and appropriate documentation for the procedure is completed, both groups will take the same surveys again.
Time Frame
Immediately after procedure

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant females
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Music's Effects on Anxiety During Epidural Placement

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