Dosing Music for Anxiety Reduction in Parturients

NCT05966766 | Completed Results

• 1 other identifier: 00003958
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4-8 minutes

Secondary Outcomes (1)

• STAI

  4-8 minutes

Study Arms (2)

Mozart

ACTIVE COMPARATOR

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

Patient preference

ACTIVE COMPARATOR

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

Other: Patient-preferred music selections

Interventions

Mozart selections 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.

Mozart

Patient-preferred music selections 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.

Patient preference

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Limitations and Caveats

Minimum required number of participants recruited was achieved. Larger sample sizes may have yielded results of stronger statistical significance.

Results Point of Contact

• Title: Dan Drzymalski, MD
• Organization: Tufts Medical Center

dan.drzymalski@tuftsmedicine.org

617-913-8168‬‬‬‬‬‬‬‬‬‬‬‬‬‬

Study Officials

• Dan Drzymalski, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: December 7, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-05

Locations

US (1)