NCT Number: NCT07278804
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.
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Location status: Recruiting
Elizabeth Thomason, MD, MPH
CONTACT
Elizabeth Thomason, MD, MPH
PRINCIPAL_INVESTIGATOR
Emile Gleeson, MD
SUB_INVESTIGATOR
Nishita Pondugula, MD
CONTACT
Nishita Pondugula, MD, MS
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A menu of pain control options available to participants to choose from during IUD (intrauterine device) insertion procedure
Time frame: Day of study enrollment/IUD insertion
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.
Time frame: Day of IUD insertion procedure, 24 hours after IUD insertion procedure
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.
Time frame: Day of IUD insertion procedure, 24 hours after IUD insertion procedure
Patients will be asked whether the pain they experienced was less than, the same as, or more pain than they expected.
Time frame: Day of IUD insertion procedure, 24 hours after IUD insertion procedure
Patient's will be asked to rate their overall satisfaction with their IUD insertion experience on a scale from 0-10.
Time frame: Day of IUD insertion procedure, 24 hours after IUD insertion procedure
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.
Contact information is provided by the study sponsor or research team.
Elizabeth Thomason, MD, MPH
CONTACT
Nishita Pondugula, MD, MS
CONTACT
Duke University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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