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NCT Number: NCT07311824

Pain Management for In-Office Gynecologic Procedures Using 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.

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Key information

Conditions

Pain Management Agnosia Behavior Gynecologic Procedures Health Behavior Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Patient Satisfaction Perceptual Disorders Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Carle Champaign on Curtis, Champaign, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: risk-stratification calculator, risk-stratification algorithm

Primary outcomes

  1. Average Perceived Pain Score

    Time frame: At time of procedure and at 10 minutes after procedure

    Participants will rank their pain perceived during their procedures from 0, equivalent to no pain, to 10, equivalent to worst imaginable pain.

  2. Participant Satisfaction with Procedure

    Time frame: At time of 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.

Secondary outcomes

  1. Average Perceived Pain Stratified by Risk Group

    Time frame: At time of procedure and at 10 minutes after procedure

    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.

  2. Participant Satisfaction with Procedure Stratified by Risk Group

    Time frame: at time of procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Beverly London, MD

CONTACT

[email protected]

217-365-6208

Claire M Aucoin, MD

CONTACT

[email protected]

217-383-3140 ext. 3

Sponsors and collaborators

Lead sponsor

Carle Foundation Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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