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Development of a Pain Control Options Menu for IUD Insertion

Development of a Pain Control Options Menu for IUD Insertion

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07278804
Enrollment
200
Registered
2025-12-12
Start date
2026-01-16
Completion date
2026-12-01
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUD Insertion Pain

Keywords

IUD insertion, Pain control options menu, Pain control

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.

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.

Interventions

OTHERPain control options menu

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

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified PCCC Autonomy ScoreDay of study enrollment/IUD insertionA 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.

Secondary

MeasureTime frameDescription
Highest level of pain experiencedDay of IUD insertion procedure, 24 hours after IUD insertion procedurePatients 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.
Number of participants in which pain felt met expectationsDay of IUD insertion procedure, 24 hours after IUD insertion procedurePatients will be asked whether the pain they experienced was less than, the same as, or more pain than they expected.
Patient satisfaction scoreDay of IUD insertion procedure, 24 hours after IUD insertion procedurePatient's will be asked to rate their overall satisfaction with their IUD insertion experience on a scale from 0-10.
Number of participants who would choose an IUD for contraception againDay of IUD insertion procedure, 24 hours after IUD insertion procedurePatient 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.

Countries

United States

Contacts

CONTACTNishita Pondugula, MD, MS
nishita.pondugula@duke.edu817-734-8597
CONTACTElizabeth Thomason, MD, MPH
elizabeth.i.deans@duke.edu984-209-8734
PRINCIPAL_INVESTIGATORElizabeth Thomason, MD, MPH

Duke University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026