Development of a Pain Control Options Menu for IUD Insertion

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.

Study Overview

• Status: Recruiting
• Conditions: IUD Insertion Pain
• Intervention / Treatment: Other: Pain control options menu

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emile Gleeson, MD; Phone Number: 206-369-3035; Email: eig9@duke.edu
• Study Contact Backup: Name: Elizabeth Thomason, MD, MPH; Phone Number: 984-209-8734; Email: elizabeth.i.deans@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Hospital
      • Contact: Emile Gleeson, MD; Phone Number: 206-369-3035; Email: eig9@duke.edu
      • Contact: Elizabeth Thomason, MD, MPH; Phone Number: 984-209-8734; Email: elizabeth.i.deans@duke.edu
      • Principal Investigator: Elizabeth Thomason, MD, MPH
      • Sub-Investigator: Emile Gleeson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No menu - control group; Control group - no intervention administered
Experimental: Menu - intervention group; Participants will receive the pain control options menu prior to IUD insertion	Other: Pain control options menu; A menu of pain control options available to participants to choose from during IUD (intrauterine device) insertion procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day of study enrollment/IUD insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Day of IUD insertion procedure, 24 hours after IUD insertion procedure

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Elizabeth Thomason, MD, MPH, Duke University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pain control; IUD insertion; Pain control options menu
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: Pro00117230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No