Pain Management for In-Office Gynecologic Procedures Using a Risk-Stratification Pain Calculator
NCT ID: NCT07311824
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-12-29
2027-04-30
Brief Summary
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* Does using pain medications determined by a risk-stratification calculator improve patients' pain scores during if-office gynecologic procedures?
* Does using pain medications determined by a risk-stratification calculator improve patient satisfaction?
Researchers will compare using the risk-stratification calculator to decide on pain medications to a provider using their best judgement to decide on pain medications. This will help determine if patients have improved pain scores and satisfaction if they have their pain medications assigned using the risk-stratification calculator.
Participants who are undergoing a relevant in-office gynecologic procedure will:
* Receive pain medications for their procedure either based on their answers to questions for the risk-stratification calculator or based on their provider's best judgement.
* Answer an online survey about their experience with the procedure and related pain management.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pain Calculator
Participants will answer the Pain Calculator Questionnaire that will determine if they are low, moderate, or high risk for severe pain during their procedure. They will receive assigned pain medications based on their risk.
Pain Calculator
The risk-stratification calculator, or the Pain Calculator, will be a questionnaire that the participant will answer with a research team member. The questions asked will include age, menopausal status, delivery history, history of certain gynecologic disorders, past experiences with gynecologic procedures, and anxiety about their upcoming procedure. Their answers will sort participants into low, moderate, and high risk groups. Each group will receive escalating pain medications for their procedure.
Control
Participants will have their pain management determined by the provider's best judgement, using shared decision making
No interventions assigned to this group
Interventions
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Pain Calculator
The risk-stratification calculator, or the Pain Calculator, will be a questionnaire that the participant will answer with a research team member. The questions asked will include age, menopausal status, delivery history, history of certain gynecologic disorders, past experiences with gynecologic procedures, and anxiety about their upcoming procedure. Their answers will sort participants into low, moderate, and high risk groups. Each group will receive escalating pain medications for their procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Proficient in English
* Access to personal smart devices (smartphone, tablet, laptop, etc.)
* Will be undergoing the following in-office gynecologic procedures: IUD insertion, endometrial biopsy, colposcopy with cervical biopsy, or hysteroscopy
Exclusion Criteria
* Non-English-Speaking
* Have contraindications to taking NSAIDs, acetaminophen, lidocaine or its derivatives, or opioids
* Patients who are taking methadone, Suboxone, and/or naltrexone
18 Years
FEMALE
No
Sponsors
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Carle Foundation Hospital
OTHER
Responsible Party
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Claire Aucoin
Co-Investigator
Principal Investigators
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Beverly London, MD
Role: PRINCIPAL_INVESTIGATOR
Carle Foundation Hospital
Georgina Cheng, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Carle Foundation Hospital
Locations
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Carle Champaign on Curtis
Champaign, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Beverly M London, MD
Role: primary
Claire M Aucoin, MD
Role: backup
Claire M Aucoin, MD
Role: primary
Beverly London, MD
Role: backup
Other Identifiers
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24CRU4052
Identifier Type: -
Identifier Source: org_study_id