Clinical trial NCT06529003: TENS Unit To Decrease Pain After Laminaria Insertion
Official title: Randomized Controlled Trial: TENS Unit To Decrease Pain After Laminaria Insertion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Second Trimester Abortion
Lead sponsor: Queen's Medical Center
Sponsor class: OTHER
Collaborators: name: University of Hawaii Foundation
First posted: 2024-07-31
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing laminaria insertion for D\&amp;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\&amp;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

Primary outcomes:
measure: Maximum pain scores
timeFrame: Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
Secondary outcomes:
measure: Pain at time of laminaria insertion
timeFrame: At time of laminaria insertion
measure: Number of TENS sessions
timeFrame: Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
measure: Duration of each TENS sessions
timeFrame: Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
measure: Satisfaction with pain management
timeFrame: Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
measure: Ease of use
timeFrame: Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
measure: Analgesic use
timeFrame: Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours)
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: 1380 Lusitana St. Ste 1004
state: Hawaii
Study officials:
affiliation: Complex Family Planning, The Queens Medical Center, Department of Obstetrics, Gynecology, and Womens Health
name: Melissa Natavio, MD, MPH
role: STUDY_DIRECTOR
References: