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

NCT07311824 | Not Yet Recruiting

• 1 other identifier: 24CRU4052
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pain Management; Patient Satisfaction; Gynecologic Procedures

Keywords

pain management; patient satisfaction; gynecologic procedures; IUD insertion; hysteroscopy; endometrial biopsy; colposcopy; ambulatory gynecologic procedures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Average Perceived Pain Stratified by Risk Group

  At time of procedure and at 10 minutes after procedure

• Participant Satisfaction with Procedure Stratified by Risk Group

  at time of procedure

Study Arms (2)

Pain Calculator

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants will have their pain management determined by the provider's best judgement, using shared decision making

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.

Also known as: risk-stratification calculator, risk-stratification algorithm

Pain Calculator

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carle Foundation Hospital: lead

Study Sites (2)

Carle Champaign on Curtis

Champaign, Illinois, 61822, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Agnosia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Beverly London, MD

  Carle Foundation Hospital

  PRINCIPAL INVESTIGATOR

• Georgina Cheng, MD PhD

  Carle Foundation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire M Aucoin, MD

CONTACT

217-383-3140; claire.aucoin@carle.com

Beverly London, MD

CONTACT

217-365-6208; beverly.london@carle.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 31, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)