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Development of a Pain Control Options Menu for IUD Insertion

NCT ID: NCT07278804

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-16

Study Completion Date

2026-07-31

Brief Summary

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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 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.

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Detailed Description

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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

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IUD Insertion Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Will initially enroll a control group that does not receive any intervention, after control group data is complete, will enroll for the intervention group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Menu - intervention group

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

Group Type EXPERIMENTAL

Pain control options menu

Intervention Type OTHER

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

No menu - control group

Control group - no intervention administered

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pain control options menu

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Having an IUD placed in the operating room under general anesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Thomason, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University Hospital

Locations

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Duke University Hospital

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emile Gleeson, MD

Role: CONTACT

[email protected]
206-369-3035

Elizabeth Thomason, MD, MPH

Role: CONTACT

[email protected]
984-209-8734

Facility Contacts

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Emile Gleeson, MD

Role: primary

[email protected]
206-369-3035

Elizabeth Thomason, MD, MPH

Role: backup

[email protected]
984-209-8734

Other Identifiers

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Pro00117230

Identifier Type: -

Identifier Source: org_study_id

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