Dosing Music for Anxiety Reduction in Parturients

Study Overview
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Brief Summary
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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 95% of subjects should have a positive response.

Official Title
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Estimating the Effective Dose of Music Duration for Anxiety Reduction Prior to Cesarean Delivery

Conditions
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Anxiety

Intervention / Treatment
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* Other: Mozart selections
* Other: Patient-preferred music selections


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Planning on scheduled cesarean section or non-emergent unscheduled cesarean section Able to provide informed consent American Society of Anaesthesiologists (ASA) physical status score of II-III Exclusion Criteria: Patient refusal Impaired hearing Patient is taking at least one anxiolytic medication daily at baseline No anxiety (a score of 0, on a scale of 0-10, of pre-music exposure anxiety) after consent is given ASA IV or higher

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mozart<br>Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety. | Other: Mozart selections<br>* Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections by Mozart of previously studied and shown to reduce anxiety.<br>|
| Active Comparator: Patient preference<br>Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing. | Other: Patient-preferred music selections<br>* Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections of patient choice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Score | STAI questionnaire consisting of rating pain and anxiety on scale of 0-10 followed by 6 questions to further qualitatively assess anxiety levels. | 1-8 hours |