Dosing Music for Anxiety Reduction in Parturients

Tufts Medical Center40 enrolled

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 95% of subjects should have a positive response.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anxiety

Interventions

Mozart selectionsOTHER

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.

Patient-preferred music selectionsOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Tufts Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Anxiety Score

Verbally rated anxiety on numeric rating scale (NRS) of 0-10, before and after intervention. A rating of 0 meant the patient had no anxiety, while a rating of 10 meant the patient had the worst anxiety possible. Must have been at least a 1-point decrease between pre- and post-intervention scores to be considered a positive response, larger decrease meant a better outcome.

Time frame: 4-8 minutes

Secondary Outcomes

STAI

6-question abbreviated state-trait anxiety inventory (STAI) questions asked and scored on a 6-24 point scale (higher is more anxiety) for before and after intervention. Decrease in score after intervention was considered a positive response, with larger decreases indicating better responses.

Time frame: 4-8 minutes

Data from ClinicalTrials.gov

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