Pain Management for IUD Insertion

Overseen By Emile Gleeson, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: IUD under general anesthesia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether offering a menu of pain management options can improve the experience of getting an IUD (a birth control device placed in the uterus). The researchers aim to determine if having choices can give patients more control, increase satisfaction with the process, and reduce pain. Participants will complete surveys about their feelings during IUD insertion. The trial seeks individuals who are getting an IUD during a regular clinic visit and can read and speak English.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance patient experiences with IUD insertions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on evaluating pain management options during IUD insertion, so it's likely you can continue your usual medications, but please confirm with the trial coordinators.

What prior data suggests that this pain management options menu is safe for IUD insertion?

Studies have shown safe ways to manage pain during IUD (intrauterine device) insertion. Research indicates that local anesthetics like lidocaine spray or cream, or numbing the area around the cervix, are effective and well-tolerated. These treatments are recommended to reduce discomfort during the procedure.

Discussing pain management options with patients can also improve their experience. By focusing on patient preferences, healthcare providers can offer various safe options to manage pain effectively.

Overall, evidence supports the safety and effectiveness of pain control methods for IUD insertion, helping to reduce pain for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing pain during IUD insertion. Unlike traditional methods that often involve local anesthetics or oral painkillers, this trial uses a "pain control options menu," which empowers patients to choose from various pain management strategies tailored to their preferences and needs. This personalized approach could enhance patient comfort and satisfaction by offering a more customized experience compared to the one-size-fits-all standard treatments. By providing patients with options, this method aims to make the IUD insertion process less daunting and more patient-centered.

What evidence suggests that a pain management options menu is effective for improving patient autonomy, satisfaction, and pain during IUD insertion?

Research has shown that offering different pain relief options for IUD insertion can help reduce discomfort. In this trial, participants in the intervention group will receive a menu of pain control options before IUD insertion. One study found that combining several pain-relief methods, such as taking oral painkillers, numbing the cervix, and gently opening it, can lessen pain and complications during the procedure. Another study found that local anesthetics, like lidocaine cream, effectively reduce pain. Clinical data also indicate that certain devices can significantly lower pain during the IUD procedure. This suggests that providing various pain management options could make the experience less painful and more satisfactory for patients. ^{1 3 4 6 7}

Who Is on the Research Team?

Elizabeth Thomason, MD, MPH

Principal Investigator

Duke University Hospital

Are You a Good Fit for This Trial?

This trial is for individuals undergoing IUD insertion who wish to have control over their pain management options. The study seeks participants willing to provide feedback on their experience through surveys, focusing on autonomy, satisfaction, and pain levels.

Inclusion Criteria

Able to read and speak English

I am between 18 and 50 years old.

I have an IUD that was inserted at a clinic.

Exclusion Criteria

I had an IUD inserted while under general anesthesia in surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive the pain control options menu prior to IUD insertion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction, autonomy, and pain after IUD insertion

1-2 days

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Pain control options menu

Trial Overview

The study is testing whether a menu of pain control options offered before IUD insertion can improve the patient's sense of autonomy, overall satisfaction with the procedure, and reduce discomfort. It involves comparing survey responses pre- and post-implementation of this menu.

How Is the Trial Designed?

Group I: Menu - intervention group Experimental Treatment 1 Intervention

Participants will receive the pain control options menu prior to IUD insertion

Group II: No menu - control group Active Control 1 Intervention

Control group - no intervention administered

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1.

contraceptionjournal.org

contraceptionjournal.org/article/S0010-7824(24)00332-9/fulltext

p058 - efficacy of a standardized, multimodal approach to ...

We aimed to evaluate the efficacy of a multimodal “bundle” to reduce pain and complications associated with intrauterine device (IUD) insertion.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11569790/

Pain Management During Intrauterine Device Insertion in ...

The research reveals that management to minimize pain during IUD insertion can include oral analgesics, cervical blocks, and cervical softening and dilation ...

3.

ajog.org

ajog.org/article/S0002-9378(25)00072-9/fulltext

Best practices for reducing pain associated with ...

A systematic review and network meta-analysis concluded that EMLA cream (lidocaine 2.5% and prilocaine 2.5%) was the most effective in decreasing pain at ...

4.

acog.org

acog.org/news/news-releases/2025/05/acog-releases-new-recommendations-on-pain-management-for-iud-insertions-other-in-office-gynecologic-procedures

ACOG Releases New Recommendations on Pain ...

The guidance recommends clinicians offer local anesthetics for IUD insertions, such as lidocaine spray, lidocaine-prilocaine cream, and paracervical block.

5.

aspivix.com

aspivix.com/clinical-data-show-significantly-lower-iud-procedural-pain-and-bleeding-rates-with-aspivixs-novel-suction-based-cervical-device/

Clinical data show significantly lower IUD procedural pain ...

Pain scores were 52% lower with the Carevix® device during cervix grasping, 53% lower during cervix stabilization (traction), 30% lower during ...

6.

contraceptionjournal.org

contraceptionjournal.org/article/S0010-7824(25)00135-0/fulltext

Beyond pain medication: striving toward more patient ...

This mixed-methods study included a survey and in-depth interviews of patients undergoing IUD placement. Participants reported pain, satisfaction, ...

7.

cdc.gov

cdc.gov/mmwr/volumes/73/rr/rr7303a1.htm

U.S. Contraceptive Use Recommendations 2024 | MMWR

A person-centered plan for IUD placement and pain management should be made based on patient preference. Barriers to IUD use include patient ...