Development of a Pain Control Options Menu for IUD Insertion

NCT07278804 | Recruiting

• 1 other identifier: Pro00117230
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

IUD Insertion Pain

Keywords

IUD insertion; Pain control options menu; Pain control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Highest level of pain experienced

  Day of IUD insertion procedure, 24 hours after IUD insertion procedure

• Number of participants in which pain felt met expectations

  Day of IUD insertion procedure, 24 hours after IUD insertion procedure

• Patient satisfaction score

  Day of IUD insertion procedure, 24 hours after IUD insertion procedure

• Number of participants who would choose an IUD for contraception again

  Day of IUD insertion procedure, 24 hours after IUD insertion procedure

Study Arms (2)

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

Other: Pain control options menu

Interventions

Pain control options menu OTHER

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

Menu - intervention group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Having an IUD placed in the operating room under general anesthesia

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elizabeth Thomason, MD, MPH

  Duke University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emile Gleeson, MD

CONTACT

206-369-3035; eig9@duke.edu

Elizabeth Thomason, MD, MPH

CONTACT

984-209-8734; elizabeth.i.deans@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Will initially enroll a control group that does not receive any intervention, after control group data is complete, will enroll for the intervention group.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: January 16, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)