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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain control options menu | Other | A menu of pain control options available to participants to choose from during IUD (intrauterine device) insertion procedure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emile Gleeson, MD | Contact | 206-369-3035 | eig9@duke.edu | |
| Elizabeth Thomason, MD, MPH | Contact | 984-209-8734 | elizabeth.i.deans@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Thomason, MD, MPH | Duke University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Recruiting | Durham | North Carolina | 27710 | United States |
IPD will not be shared.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Will initially enroll a control group that does not receive any intervention, after control group data is complete, will enroll for the intervention group.
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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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |