IUD Insertion PainNCT07278804

Development of a Pain Control Options Menu for IUD Insertion

A study of IUD Insertion Pain, run by Duke University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

The goal of this study is to evaluate if using a pain management options menu for IUD (intrauterine device) insertion improves patient autonomy, satisfaction, and/or pain. The main questions it aims to answer are: Does a pain management options menu for IUD insertion improve patient autonomy? Does a pain management… Read more about this study

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: IUD Insertion Pain
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteUnited States
Study dates: 16 Jan 2026to Dec 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

Having an IUD placed in a clinic visit
Able to read and speak English
Age 18-50 years old

Who cannot join

Having an IUD placed in the operating room under general anesthesia

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nishita Pondugula, MD, MS contact

817-734-8597

nishita.pondugula@duke.edu

Elizabeth Thomason, MD, MPH contact

984-209-8734

elizabeth.i.deans@duke.edu

United States1 site, 1 recruiting

Duke University Hospital
Durham, North Carolina, 27710
Nishita Pondugula, MD, 817-734-8597, nishita.pondugula@duke.edu
Elizabeth Thomason, MD, MPH, 984-209-8734, elizabeth.i.deans@duke.edu
Recruiting

Other trials in United States

About this study

Does a pain management options menu for IUD insertion improve patient autonomy? Does a pain management options menu for IUD insertion improve patient satisfaction? Does a pain management options menu for IUD insertion improve patient pain?

Researchers will compare survey data from patients receiving IUDs before and after a pain management options menu is implemented.

Participants will be asked to answer survey questions addressing their feelings of autonomy, satisfaction, and pain in regards to their IUD insertion experience.

Read the detailed description

The investigators are developing a pain management options menu to be given to patients who are undergoing IUD insertion with the goal of improving patient autonomy, satisfaction, and pain scores. The investigators will give patients a survey exploring these aspects of the IUD insertion experience and compare the survey results from patients who were surveyed before the menu was implemented and after the menu was implemented.

Conditions: IUD Insertion Pain
Being tested: Pain control options menu
Keywords: IUD insertion, Pain control options menu, Pain control
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pain control options menuOther
A menu of pain control options available to participants to choose from during IUD (intrauterine device) insertion procedure

Study groups in NCT07278804
Study group	Role	What they receive
No menu - control group	No intervention	Control group - no intervention administered
Menu - intervention group	Experimental	Participants will receive the pain control options menu prior to IUD insertion Receives: Other: Pain control options menu

What is being measured

The primary outcome is the main question the study is designed to answer.

Modified PCCC Autonomy Score
A modified version of the Person-Centered Contraceptive Care (PCCC) scale will be used to measure patient autonomy. This scale is a 4-item questionnaire evaluating provider performance regarding respect for patients, information provision, and eliciting and honoring patient preferences for birth control. The total score will be a number between 4 and 20.
Measured: Day of study enrollment/IUD insertion

Secondary outcomes (4)

Highest level of pain experienced
Patients will be asked to rate the highest level of pain that they experienced during IUD insertion/during the 24 hours after IUD insertion on a scale from 0-10.
Measured: Day of IUD insertion procedure, 24 hours after IUD insertion procedure
Number of participants in which pain felt met expectations
Patients will be asked whether the pain they experienced was less than, the same as, or more pain than they expected.
Measured: Day of IUD insertion procedure, 24 hours after IUD insertion procedure
Patient satisfaction score
Patient's will be asked to rate their overall satisfaction with their IUD insertion experience on a scale from 0-10.
Measured: Day of IUD insertion procedure, 24 hours after IUD insertion procedure
Number of participants who would choose an IUD for contraception again
Patient will be asked whether they would choose an IUD for contraception again based on their IUD insertion experience. Answer options will be yes or no.
Measured: Day of IUD insertion procedure, 24 hours after IUD insertion procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jan 2026Dec 2026

First posted12 Dec 2025
Study start16 Jan 2026
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for IUD Insertion PainStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Sequential
Model description: Will initially enroll a control group that does not receive any intervention, after control group data is complete, will enroll for the intervention group.
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07278804
Sponsor's protocol ID: Pro00117230
Status last verified: Jan 2026
First submitted: 1 Dec 2025
Last updated: 23 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD will not be shared.