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

Pain Management Optimization for In-Office Gynecologic Procedures: The Development and Evaluation of a Risk-Stratification Pain Calculator

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Management; Patient Satisfaction; Gynecologic Procedures
• Intervention / Treatment: Other: Pain Calculator

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire M Aucoin, MD; Phone Number: 3 217-383-3140; Email: claire.aucoin@carle.com
• Study Contact Backup: Name: Beverly London, MD; Phone Number: 217-365-6208; Email: beverly.london@carle.com

Study Locations

• United States
  • Illinois
    • Champaign, Illinois, United States, 61822
      • Carle Champaign on Curtis
      • Contact: Claire M Aucoin, MD; Phone Number: 3 217-383-3140; Email: claire.aucoin@carle.com
      • Contact: Beverly M London, MD; Phone Number: 217-365-6208; Email: beverly.london@carle.com
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hospital
      • Contact: Claire M Aucoin, MD; Phone Number: 3 217-383-3140; Email: claire.aucoin@carle.com
      • Contact: Beverly London, MD; Email: beverly.london@carle.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 18 years of age
• 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:

• Under the age of 18
• Non-English-Speaking
• Have contraindications to taking NSAIDs, acetaminophen, lidocaine or its derivatives, or opioids
• Patients who are taking methadone, Suboxone, and/or naltrexone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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 Names: risk-stratification calculator; risk-stratification algorithm
No Intervention: Control; Participants will have their pain management determined by the provider's best judgement, using shared decision making

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Perceived Pain Score	Participants will rank their pain perceived during their procedures from 0, equivalent to no pain, to 10, equivalent to worst imaginable pain.	At time of procedure and at 10 minutes after procedure
Participant Satisfaction with Procedure	Participants will rank their satisfaction with their experience during the procedure using a standard Likert Scale, ranging from 1, not at all satisfied, to 5, highly satisfied.	At time of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Perceived Pain Stratified by Risk Group	Using the same pain scale - 0 (no pain at all) to 10 (worst imaginable pain), pain scores of experimental group participants stratified by Risk Group will be each compared to the control group.	At time of procedure and at 10 minutes after procedure
Participant Satisfaction with Procedure Stratified by Risk Group	Using the same Likert Scale - 1 (not at all satisfied) to 5 (highly satisfied), experimental group participants stratified by Risk Group will each be compared to the control group.	at time of procedure

Collaborators and Investigators

• Sponsor: Carle Foundation Hospital
• Investigators: Principal Investigator: Beverly London, MD, Carle Foundation Hospital; Principal Investigator: Georgina Cheng, MD PhD, Carle Foundation Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 29, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: hysteroscopy; colposcopy; patient satisfaction; pain management; IUD insertion; endometrial biopsy; gynecologic procedures; ambulatory gynecologic procedures
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Agnosia; Patient Satisfaction
• Other Study ID Numbers: 24CRU4052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No