TENS Unit To Decrease Pain After Laminaria Insertion
- Conditions
- Second Trimester Abortion
- Interventions
- Device: PlaceboDevice: Transcutaneous Electrical Nerve Stimulation (TENS) unit
- Registration Number
- NCT06529003
- Lead Sponsor
- Queen's Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - TENS unit Transcutaneous Electrical Nerve Stimulation (TENS) unit -
- Primary Outcome Measures
Name Time Method Maximum pain scores Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours) 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 placebo and those who use an adjunctive transcutaneous electrical nerve stimulation (TENS) unit in addition to standard of care. Participants will be asked to rank their pain on an 11-point numerical rating scale (0 to 10), with higher numbers indicating worse pain.
- Secondary Outcome Measures
Name Time Method Analgesic use Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours) Amount of ibuprofen taken and/or other analgesics
Satisfaction with pain management Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours) Participants will be asked "Overall satisfaction with pain control since the procedure: (0-10 numeric rating scale)" on all five surveys. A score of 0 indicates "extremely unsatisfied." A score of 5 indicates "neutral." A score of 10 indicates "extremely satisfied."
Ease of use Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours) Perception of the ease of use of the TENS unit. At the initial 10-minute mark survey, participants will be asked, "How difficult do you feel it will be to use a TENS unit? (0-10 numeric rating scale)". On the final survey (pre-op survey), only participants in the intervention group will be asked, "How difficult was it to use a TENS unit? (0-10 numeric rating scale)". A score of 0 indicates "not difficult at all." A score of 10 indicates "very difficult."
Pain at time of laminaria insertion At time of laminaria insertion Pain scores at the time of laminaria insertion. Participants will be asked to rank their pain on an 11-point numerical rating scale (0 to 10), with higher numbers indicating worse pain.
Number of TENS sessions Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours) Number of TENS sessions
Duration of each TENS sessions Between osmotic dilator placement and dilation and evacuation procedure (approximately 16-24 hours) Duration of each TENS sessions
Trial Locations
- Locations (1)
1380 Lusitana St. Ste 1004
🇺🇸Honolulu, Hawaii, United States