A Randomized Controlled Trial of Playing "The Most Relaxing Song in the World" During Labor Epidural Placement and Its Effects on Anxiety and Satisfaction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Mean Score of Anxiety Before Epidural Placement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Intervention Group
The song "Weightless" by Marconi Union will be playing during subjects labor epidural placement.
Intervention: Song "Weightless" by Marconi Union (Other)
Non Intervention Group
No song will be played during subjects labor epidural placement.
Intervention: No Song (Other)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
David Gutman
Principal Investigator
Medical University of South Carolina