Status:

TERMINATED

Music as a Nonpharmacologic Approach to Pain Control With Intrauterine Device Placement

Lead Sponsor:

Icahn School of Medicine at Mount Sinai

Conditions:

Contraception

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The intervention of this study is the addition of patient-selected music during IUD insertion procedure. Subjects randomized to the music group will choose 10 songs, which will be played during the pr...

Detailed Description

This is a prospective, two-center, randomized controlled trial evaluating whether music reduces pain and improves satisfaction during IUD insertion. Computer-generated randomization assignments will a...

Eligibility Criteria

Inclusion

  • Provision of signed and dated informed consent form
  • Nulliparous adult females age 18 years or older (nulliparous is defined as no prior pregnancies greater than or equal to 20 weeks of gestation)
  • English-speaking patients
  • Undergoing insertion of a copper or levonorgestrel intrauterine device
  • Willing to comply with all study procedures

Exclusion

  • Non-English speaking patients
  • Patients with a support person in the room during IUD insertion
  • Patients desiring a paracervical block for analgesia

Key Trial Info

Start Date :

December 14 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 16 2021

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT04835701

Start Date

December 14 2020

End Date

November 16 2021

Last Update

July 15 2022

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Mount Sinai Beth Israel

New York, New York, United States, 10003

2

Mount Sinai West

New York, New York, United States, 10019