CompletedNot Applicable

Music to Reduce Patient Reported Pain During Intrauterine Device (IUD) Placement in the Office

United States96 participantsStarted 2020-08-28

Plain-language summary

This study seeks to determine if music reduces pain and anxiety in comparison to routine pain control measures alone during insertion of intrauterine contraceptive devices (Mirena, Paragard)

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women who have an appointment for IUD insertion at either RWJ or RMG * Women who are able to read and write in English or Spanish * Age equal to or greater than 18 years Exclusion Criteria: * Contraindications to IUD placement: Active pelvic infection, pregnancy, known distortion of uterine cavity, Wilson's disease (Paragard® only), breast cancer (Mirena® only)

What they're measuring

Pain to be reported via a 10 point visual analog scale (VAS)

Timeframe: Immediately prior to the procedure, at the point of speculum insertion, at the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure

Pain to be reported via a 10 point visual analog scale (VAS)

Timeframe: At the point of speculum insertion, at the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure

Pain to be reported via a 10 point visual analog scale (VAS)

Timeframe: At the point of tenaculum placement, at the point of intrauterine device insertion, and five minutes post-procedure

Pain to be reported via a 10 point visual analog scale (VAS)

Timeframe: At the point of intrauterine device insertion, and five minutes post-procedure

Pain to be reported via a 10 point visual analog scale (VAS)

Timeframe: Five minutes post-procedure

Trial details

NCT IDNCT05068245

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-21

View on ClinicalTrials.gov More Pain, Acute trials