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

Stopped early · Not applicable

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT04835701

Run by

Icahn School of Medicine at Mount Sinai

People needed

8

Starts

2020-12-14

Expected to finish

2021-11-16

Last updated by the study team

2022-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Mount Sinai Beth Israel — New York, New York, United States
• Mount Sinai West — New York, New York, United States

Full record on ClinicalTrials.gov

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