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Behavioural Intervention

TENS Unit for Pain After Abortion

N/A
Waitlist Available
Research Sponsored by Queen's Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing laminaria insertion for D&E procedure
Age 18 years or older
Must not have
Exposure to adjunctive pharmacologic cervical preparation (misoprostol or mifepristone) within 48 hours of the D&E procedure
Contraindication to ibuprofen or bupivacaine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
Awards & highlights

Summary

This trial aims to investigate if a TENS unit, a non-medication device for pain relief, can reduce pain for patients undergoing a second-trimester termination of pregnancy during and after a procedure called

Who is the study for?
This trial is for individuals undergoing laminaria placement as part of a second-trimester termination of pregnancy, seeking non-medication pain relief. Specific eligibility details are not provided, but typically include being in good health and providing informed consent.
What is being tested?
The study investigates if a TENS unit, which is a device that delivers small electrical pulses to the body for pain relief, can reduce discomfort during and after laminaria insertion compared to a placebo (inactive treatment).
What are the potential side effects?
TENS units are generally safe but may cause skin irritation where the pads attach, muscle twitching, or an uncomfortable tingling sensation. The intensity of these side effects varies among users.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having a laminaria insertion for my D&E procedure.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken medication to prepare for a D&E procedure within the last 48 hours.
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I cannot take ibuprofen or bupivacaine due to health reasons.
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I don't have a pacemaker, epilepsy, bleeding disorders, cancer, or use transdermal drug patches.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum pain scores
Secondary study objectives
Analgesic use
Duration of each TENS sessions
Ease of use
+3 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TENS unitActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Queen's Medical CenterLead Sponsor
23 Previous Clinical Trials
4,882 Total Patients Enrolled
University of Hawaii FoundationUNKNOWN
1 Previous Clinical Trials
22 Total Patients Enrolled
Melissa Natavio, MD, MPHStudy DirectorComplex Family Planning, The Queens Medical Center, Department of Obstetrics, Gynecology, and Womens Health
~24 spots leftby Apr 2025
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