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“Dosing Music for Anxiety Reduction in Parturients“


Title “Estimating the effective dose of music duration for anxiety reduction prior to scheduled cesarean section” 
Therapeutic Area Anxiety
Principal Investigator Dan Drzymalski, MD
Min Age 18 Years
Gender Female
Contact Dan Drzymalski, MD (PI) or Tristan Fong (Co-Investigator)
(617)-636-6044
tristan.fong@tufts.edu

Overview

This is a clinical study that aims to determine the effective dose of music listening duration that is required to reduce anxiety in patients awaiting scheduled cesarean section. It will also compare types of music to accomplish this goal, both of which have been shown effective in prior studies. Methods will involve enrolling and playing music for patients awaiting scheduled C-section, and scoring their anxiety with pre- and post-music questionnaires. Music duration for each subject will be predetermined, and analysis of response will be performed to determine the effective dose 95%, or dose at which there is a 95% chance of subjects having a positive response.

Study Details

Inclusion Criteria

• Age 18 or older • Planning on scheduled cesarean section • Able to provide informed consent

Exclusion Criteria

  • Impaired hearing
    • Patient is taking at least one anxiolytic medication daily at baseline
    • No anxiety

Study Requirements

• Participation in this study will be done entirely during the pre-operative waiting period before scheduled cesarean section • Each participant will be asked to listen to music for a pre-determined amount of time • Anxiety assessment will be performed using a 0-10 scale once before listening and three times after • A series of six additional questions will also be asked directly before and after music listening to further evaluate anxiety • Blood pressure and heart rate measurements will be performed at all anxiety assessments • Total study participation time will be between 1 and 8 hours, depending on how long the pre-operative waiting period happens to be, which this study will not affect • Total music listening time will be less than 30 minutes