Randomized, Placebo-Controlled Study on the Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pain During IUD Insertion as Measured by the VAS Score
Study Overview
Brief Summary
Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18-45 years old
- •Individuals with a cervix and uterus
- •Seeking intrauterine device (IUD) placement for contraception or management of abnormal uterine bleeding
- •Meet medical eligibility for IUD placement
- •Ability to consent in English
- •Ability to use the visual analogue scale (VAS)
Exclusion Criteria
- •Contraindications to IUD placement
- •Use of analgesics within the last 4 hours prior to IUD placement
- •Presence of a pacemaker
Arms & Interventions
Active TENS unit
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Intervention: Transcutaneous electrical nerve stimulation (TENS) (Device)
Non-active TENS unit
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
Intervention: Placebo Transcutaneous electrical nerve stimulation (TENS) (Device)
Outcomes
Primary Outcomes
Pain During IUD Insertion as Measured by the VAS Score
Time Frame: IUD placement/introducer removal up to 5 minute
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Secondary Outcomes
- Pain During IUD Insertion as Measured by the VAS Score(speculum placement up to 1 minute)
- Pain During IUD Insertion as Measured by the VAS Score(tenaculum placement up to 1 minute)
- Pain During IUD Insertion as Measured by the VAS Score(sound insertion up to 5 minute)
- Pain Post IUD Insertion as Measured by the VAS Score(5 minute post IUD insertion)
Investigators
Jean Marino
APRN-CNP
University Hospitals Cleveland Medical Center