Dosing Music for Anxiety Reduction in Parturients
- Conditions
- Anxiety
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- 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
- 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
- Primary Outcome Measures
Name Time Method Anxiety Score 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 Outcome Measures
Name Time Method STAI 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.
Trial Locations
- Locations (1)
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Tufts Medical Center🇺🇸Boston, Massachusetts, United States