Using a TENS unit to reduce pain after laminaria insertion
Randomized Controlled Trial: TENS Unit To Decrease Pain After Laminaria Insertion
This study is testing whether using a TENS unit can help reduce pain for patients getting laminaria inserted before a second-trimester abortion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Queen's Medical Center Academic / other |
| Locations | 1 site (Honolulu, Hawaii) |
| Trial ID | NCT06529003 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a transcutaneous electrical nerve stimulation (TENS) unit as a non-medication pain relief option for patients undergoing laminaria insertion prior to a second-trimester abortion. Participants will be divided into two groups: one receiving standard care with a placebo and the other using the TENS unit in addition to standard care. The primary focus is to compare maximum pain scores reported during the interval between osmotic dilator placement and the dilation and evacuation (D&E) procedure. Secondary objectives include evaluating pain scores at the time of laminaria insertion, additional analgesic use, and patient satisfaction with pain management.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older undergoing laminaria insertion for a D&E procedure.
Not a fit: Patients with contraindications to TENS or those who have recently used adjunctive pharmacologic cervical preparation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological option for pain management during a sensitive medical procedure.
How similar studies have performed: While the use of TENS units for pain management is established in other contexts, this specific application in second-trimester abortion is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing laminaria insertion for D\&E procedure * Age 18 years or older * Capability and willingness to send and receive SMS messages by phone and complete web-based surveys * Capability to read and understand directions for using a TENS unit * Capability to operate a TENS unit according to provided directions Exclusion Criteria: * Inability to complete the informed consent in English * Exposure to adjunctive pharmacologic cervical preparation (misoprostol or mifepristone) within 48 hours of the D\&E procedure * Contraindication to ibuprofen or bupivacaine * Contraindication to TENS, including cardiac pacemakers, epilepsy, bleeding disorders, cancer, and concurrent use near transdermal drug delivery systems * Previous participation in this trial * Prior use of TENS unit
Where this trial is running
Honolulu, Hawaii
- 1380 Lusitana St. Ste 1004 — Honolulu, Hawaii, United States (Recruiting)
Study contacts
- Study coordinator: Shani Ma, MD
- Email: shanima@hawaii.edu
- Phone: 808-375-3785
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.