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

NCT04835701 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-07-15

No results posted yet for this study

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 procedure, from the time of positioning through completion of IUD insertion and speculum removal. Music may be played through a portable speaker in close proximity to the patient or through the patient's own headphones, if preferred. Music will be played at a low enough volume for subjects to hear standard anticipatory guidance during the procedure. Both control and music groups will otherwise undergo the same standard protocol for IUD insertion in an outpatient clinic setting. Total participation is predicted to last approximately 30 minutes.

Subjects in both control and intervention groups will undergo the same assessment of pain during IUD insertion using the 100-mm visual analog scale (VAS). This will be administered at 8 points during the procedure. All subjects will also answer the same 5-question satisfaction survey following IUD insertion. Pain scores will be measured and compared between music and control groups to assess the primary and secondary outcomes of this study.

Conditions

  • Contraception

Interventions

BEHAVIORAL

Music

Music may be played through a portable speaker in close proximity to the patient or through the patient's own headphones, if preferred. Music will be played at a low enough volume for subjects to hear standard anticipatory guidance during the procedure.

Sponsors & Collaborators

Principal Investigators

  • Neha R Bhardwaj, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2021-11-16
Completion
2021-11-16

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04835701 on ClinicalTrials.gov