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Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortionl (HAPPE)

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ClinicalTrials.gov Identifier: NCT02536235
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : September 29, 2016
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Planned Parenthood of New York City, Inc.

Brief 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.


Condition or disease Intervention/treatment Phase
Topical Heat Application for Intraoperative Abortion Pain Management Other: heat Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortion: A Randomized Controlled Trial
Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

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Arm Intervention/treatment
Experimental: Intervention: intraoperative topical heat Other: heat
activated heating pad to lower abdomen

No Intervention: Control: no intraoperative heat



Primary Outcome Measures :
  1. pain score measured on Visual Analog Scale (VAS) at time of uterine aspiration [ Time Frame: collected at time of 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.


Secondary Outcome Measures :
  1. pain score measured on VAS at time of speculum placement [ Time Frame: collected at time of 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.

  2. pain score measured on VAS at time of paracervical block [ Time Frame: collected at time of 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.

  3. pain score measured on VAS at time of tenaculum placemenet [ Time Frame: collected at time of 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.

  4. pain score measured on VAS at time of cervical dilation [ Time Frame: collected at time of 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.

  5. overall pain scores will be measured on VAS at the conclusion of the procedure [ Time Frame: collected at conclusion of 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.

  6. overall satisfaction with pain management will be measured on a 5 point Likert scale [ Time Frame: collected at conclusion of procedure ]
    Likert scale assessing satisfaction will be based on scale from 0 to 4 where 0 equals very unsatisfied and 4 equals very satisfied.



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Ages Eligible for Study:   16 Years to 51 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Gestational age of 12 6/7 wks or less by ultrasound
  • Age 16 years or older
  • Requesting pregnancy termination by surgical abortion
  • Eligible for outpatient pregnancy termination
  • Able to provide informed consent
  • English or Spanish* speaking *If research assistant hired for project is bilingual
  • Electing local anesthesia only

Exclusion Criteria

  • Reports active bleeding or severe pain at time of enrollment
  • Early pregnancy failure identified on pre-operative ultrasound
  • Skin irritation or rash over lower abdomen
  • Presumed molar pregnancy
  • Possible ectopic pregnancy
  • Electing intravenous sedation
  • Planned intra-operative sonographic guidance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536235


Locations
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United States, New York
Planned Parenthood- Boro Hall
Brooklyn, New York, United States
Sponsors and Collaborators
Planned Parenthood of New York City, Inc.
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Principal Investigator PPNYC
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Responsible Party: Planned Parenthood of New York City, Inc.
ClinicalTrials.gov Identifier: NCT02536235    
Other Study ID Numbers: SFPRF15-20
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided