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NCT02536235 · ClinicalTrials.gov registry record · NA
Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortionl
A NA study of Topical Heat Application for Intraoperative Abortion Pain Management, sponsored by Planned Parenthood of Greater New York.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT02536235 is a NA study of Topical Heat Application for Intraoperative Abortion Pain Management that has completed, run by Planned Parenthood of Greater New York. The registered enrollment target is 120 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02536235, a NA study of Topical Heat Application for Intraoperative Abortion Pain Management, has completed, sponsored by Planned Parenthood of Greater New York.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- OTHER heat
Study Locations (1)
New York
- Planned Parenthood- Boro Hall - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02536235
The ClinicalTrials.gov registry entry for NCT02536235 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Planned Parenthood of Greater New York, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Topical Heat Application for Intraoperative Abortion Pain Management appearing as the primary indexed condition, and to 1 intervention - of which heat is the first listed.
NCT02536235 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT02536235 about?
NCT02536235 is a clinical study titled "Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortionl". 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 tha...
What is the current status of trial NCT02536235?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2015-07. Estimated completion is 2016-07.
What conditions does trial NCT02536235 study?
This clinical trial studies the following conditions: Topical Heat Application for Intraoperative Abortion Pain Management.
What interventions are being tested in trial NCT02536235?
The interventions under investigation include: heat (OTHER).
Who is sponsoring clinical trial NCT02536235?
This trial is sponsored by Planned Parenthood of Greater New York, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02536235 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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