NCT06335823
Completed
Not Applicable
Randomized, Placebo-Controlled Study on the Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology
ConditionsIUD Insertion Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- IUD Insertion Pain
- Sponsor
- University Hospitals Cleveland Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pain during IUD insertion as measured by the VAS score
- Status
- Completed
- Last Updated
- last year
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.
Investigators
Jean Marino
APRN-CNP
University Hospitals Cleveland Medical Center
Eligibility Criteria
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
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(5 minute post IUD insertion)
Study Sites (1)
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