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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Participants will have their pain management determined by the provider's best judgement, using shared decision making |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire M Aucoin, MD | Contact | 217-383-3140 | 3 | claire.aucoin@carle.com |
| Beverly London, MD | Contact | 217-365-6208 | beverly.london@carle.com |
| Name | Affiliation | Role |
|---|---|---|
| Beverly London, MD | Carle Foundation Hospital | Principal Investigator |
| Georgina Cheng, MD PhD | Carle Foundation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carle Champaign on Curtis | Champaign | Illinois | 61822 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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 |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |