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OpenTrials
Completed

NCT Number: NCT05966766

Dosing Music for Anxiety Reduction in Parturients

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Anxiety Score

    Time frame: 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 outcomes

  1. STAI

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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