Pain Management for In-Office Gynecologic Procedures Using a Risk-Stratification Pain Calculator

Part of paid clinical trials in Champaign, Illinois.

Sponsor
Carle Foundation Hospital
Study ID
NCT07311824
Status
Not Yet Recruiting

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Conditions

  • Gynecologic Procedures
  • Pain Management
  • Patient Satisfaction

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pain Calculator — OTHER
    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.

Study Details

The goal of this clinical trial is to learn how using a risk-stratification calculator to determine the risk of a patient experiencing severe pain during an in-office gynecologic procedure and subsequently assigning pain medications to be used for the procedure based on risk, will affect patients' pain during these procedures. The main questions it aims to answer are: * 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.

Key Dates

Start date
Dec 29, 2025
Status verified
Dec 2025
Primary completion
Feb 28, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • No Intervention: Control
    Participants will have their pain management determined by the provider's best judgement, using shared decision making

Primary Outcome Measure

Average Perceived Pain Score [ Time Frame: At time of procedure and at 10 minutes after procedure ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Carle Champaign on CurtisChampaignIllinois61822
Beverly M London, MD
[email protected]
217-365-6208
Claire M Aucoin, MD
[email protected]
217-383-3140
Carle Foundation HospitalUrbanaIllinois61801
Claire M Aucoin, MD
[email protected]
217-383-3140
Beverly London, MD
[email protected]

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