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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
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Paracervical blocks are routinely used in first trimester surgical abortions and are a proven method for decreasing procedural pain. Even when paracervical anesthesia is used, an overwhelming majority of women still report at least moderate pain during a first trimester abortion procedure. Other than some non-pharmacologic modalities (music and visualization), only the addition of intravenous medication has been shown to reduce procedural pain. Applied topical heat is effective in alleviating pain in other medical subspecialties, and in gynecology has been shown to reduce pain from dysmenorrhea, but has never been studied for intraoperative pain control during first trimester abortion.
The investigators plan to conduct a double-blinded, randomized, controlled trial investigating the utility of topical heat application as an adjunct to paracervical block in first trimester surgical abortions up to 12 6/7wks. The primary outcome is pain score, measured using VAS, at time of uterine aspiration. As secondary outcomes, the investigators will look at the effect of heat application on pain at time of speculum placement, paracervical block, tenaculum placement, cervical dilation and overall pain. Patient satisfaction will also be assessed. If found to reduce pain during abortion under local anesthesia, the use of heat could offer an inexpensive, safe and universally available adjunct to the paracervical block during this procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: intraoperative topical heat | Experimental |
| |
| Control: no intraoperative heat | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heat | Other | activated heating pad to lower abdomen |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain score measured on Visual Analog Scale (VAS) at time of uterine aspiration | Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded. | collected at time of procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| pain score measured on VAS at time of speculum placement | Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded. | collected at time of procedure. |
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Inclusion criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | PPNYC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood- Boro Hall | Brooklyn | New York | United States |
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| ID | Term |
|---|---|
| D006358 | Hot Temperature |
| ID | Term |
|---|---|
| D013696 | Temperature |
| D013816 | Thermodynamics |
| D055585 | Physical Phenomena |
| D014887 | Weather |
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| pain score measured on VAS at time of paracervical block | Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded. | collected at time of procedure. |
| pain score measured on VAS at time of tenaculum placemenet | Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded. | collected at time of procedure. |
| pain score measured on VAS at time of cervical dilation | Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded. | collected at time of procedure. |
| overall pain scores will be measured on VAS at the conclusion of the procedure | Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded at the conclusion of the procedure. | collected at conclusion of procedure. |
| overall satisfaction with pain management will be measured on a 5 point Likert scale | Likert scale assessing satisfaction will be based on scale from 0 to 4 where 0 equals very unsatisfied and 4 equals very satisfied. | collected at conclusion of procedure |
| D001272 |
| Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |