Dosing Music for Anxiety Reduction in Parturients

Anxiety Clinical Trial

Official title:

Estimating the Effective Dose of Music Duration for Anxiety Reduction Prior to Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05966766
• Other study ID #: 00003958
• Status: Completed
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2024
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Score	STAI questionnaire consisting of rating pain and anxiety on scale of 0-10 followed by 6 questions to further qualitatively assess anxiety levels.	1-8 hours