Behavioural Intervention

TENS Unit for Pain After Abortion

Honolulu, HI

N/A

Recruiting

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)

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)

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.