Dosing Music for Anxiety Reduction in Parturients

NCT ID: NCT05966766

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-07
• Study Completion Date: 2024-05-31

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mozart

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.

Group Type: ACTIVE_COMPARATOR

Mozart selections

Intervention Type: OTHER

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 preference

Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.

Group Type: ACTIVE_COMPARATOR

Patient-preferred music selections

Intervention Type: OTHER

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.

Interventions

Mozart selections

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.

Intervention Type: OTHER

Patient-preferred music selections

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Drzymalski, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

00003958

Identifier Type: -

Identifier Source: org_study_id