Dosing Music for Anxiety Reduction in Parturients

Not Applicable

Completed

• Conditions: Anxiety

• Registration Number: NCT05966766
• Lead Sponsor: Tufts Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-08-01
• Study Start: 2023-12-07
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Results First Submitted: 2025-02-10
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Results First Posted: 2025-05-30
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety Score	4-8 minutes	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.

Secondary Outcome Measures

Name	Time	Method
STAI	4-8 minutes	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.

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States