TENS Unit To Decrease Pain After Laminaria Insertion

Queen's Medical Center

Status: Completed

Conditions: Second Trimester Abortion

Treatments: Device: Transcutaneous Electrical Nerve Stimulation (TENS) unit; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06529003

RA-2024-018

Details and patient eligibility

About

The purpose of the study is to learn more about the transcutaneous nerve stimulation (TENS) unit, an over-the-counter option for pain relief that is not a medication. The investigators are hoping to find out if this device decreases pain during and after laminaria placement for patients undergoing both elective and medically indicated second-trimester termination of pregnancy.

Full description

To compare the maximum pain scores reported during the interval between osmotic dilator placement and D&E procedure of patients receiving the standard of care plus sham placebo and those who use an adjunctive Transcutaneous electrical nerve stimulation (TENS) unit in addition to standard of care.

Secondary objectives include comparing pain scores at the time of laminaria insertion, assessing the number and duration of TENS sessions, additional analgesic use, satisfaction with pain management, and patient perception of the ease of use of the TENS unit.

Enrollment: 36 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Device: Placebo

TENS unit

Active Comparator group

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS) unit