Clincosm LogoSign in Get a demo

Dosing Music for Anxiety Reduction in Parturients

Sponsor
Tufts Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05966766
Collaborator
(none)
66
Enrollment
2
Arms
3
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mozart selections
  • Other: Patient-preferred music selections
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Estimating the Effective Dose of Music Duration for Anxiety Reduction Prior to Scheduled Cesarean Delivery
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Mozart

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.
Active Comparator: Patient preference

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.

Outcome Measures

Primary Outcome Measures

  1. Anxiety Score [1-8 hours]

    STAI questionnaire consisting of rating pain and anxiety on scale of 0-10 followed by 6 questions to further qualitatively assess anxiety levels.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Age 18 years or older

  • Planning on scheduled 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tufts Medical Center

Investigators

  • Principal Investigator: Dan Drzymalski, MD, Tufts Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT05966766
Other Study ID Numbers:
  • 00003958
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anxiety Disorders

Study Results

No Results Posted as of Aug 1, 2023