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Recruiting NCT07278804

Development of a Pain Control Options Menu for IUD Insertion

No phase Interventional IUD Insertion Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pain control options menu.
Who it may be relevant to
Registry conditions: IUD Insertion Pain. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • Modified PCCC Autonomy Score [Time frame: Day of study enrollment/IUD insertion]
Secondary outcome measures (4)
  • Highest level of pain experienced [Time frame: Day of IUD insertion procedure, 24 hours after IUD insertion procedure]
  • Number of participants in which pain felt met expectations [Time frame: Day of IUD insertion procedure, 24 hours after IUD insertion procedure]
  • Patient satisfaction score [Time frame: Day of IUD insertion procedure, 24 hours after IUD insertion procedure]
  • Number of participants who would choose an IUD for contraception again [Time frame: Day of IUD insertion procedure, 24 hours after IUD insertion procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Duke University Hospital — Durham

Identifiers

NCT: NCT07278804 · Pro00117230

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗