Dosing Music for Anxiety Reduction in Parturients

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Other: Mozart selections; Other: Patient-preferred music selections

• 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
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06

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

Arm && Interventions

Group	Intervention	Description
Mozart	Mozart selections	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.
Patient preference	Patient-preferred music selections	Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.

Primary Outcome Measures

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

Trial Locations

Locations (1)

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