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Dosing Music for Anxiety Reduction in Parturients

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Tufts University

Status

Completed

Conditions

Anxiety

Treatments

Other: Patient-preferred music selections
Other: Mozart selections

Study type

Interventional

Funder types

Other

Identifiers

NCT05966766
00003958

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Mozart
Active Comparator group
Description:
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.
Treatment:
Other: Mozart selections
Patient preference
Active Comparator group
Description:
Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.
Treatment:
Other: Patient-preferred music selections

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Tristan Fong, BS; Dan Drzymalski, MD

Data sourced from clinicaltrials.gov

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