Pain relief study for IUD insertion pulled before it started
NCT ID NCT07044622
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study planned to test whether a small electrical device (TENS) could reduce pain when placing an IUD. It was designed for adults getting a new or replacement IUD. The study was withdrawn before enrolling anyone, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Started
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Oct 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Patient Participants: * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * English-speaking individual aged 18 years or older. * Presenting for IUD initiation or replacement during ambulatory care visits to the Yale Family Planning service and Center for Women's Health and Midwifery clinic. * Opting for either LNG 52mg or copper T380A IUD. Inclusion Criteria Provider Participants: * Review of the provider participant study Information Sheet and provision of verbal consent. * IUD insertion performed by Yale Family Planning and Center for Women's Health and Midwifery clinic faculty and fellows, as well as OB/GYN residents on their family planning rotation, with IUD insertion competency. * Performing an IUD insertion on a patient participant who meets all patient participant eligibility criteria Exclusion Criteria Patient Participants: * Contraindication to IUD initiation * Current Pelvic Infection * Distorted Uterine Anatomy (I.e., uterine septum, didelphys, uterine fibroids with cavity length greater than 12mm) * Pregnancy * Any other contraindications to IUD insertion as determined by the patient's clinical care staff. * Exclusionary criteria for study participation * Current IUD with no visible strings * Contraindication or allergy to ibuprofen * History of chronic pain disorder * Recent opioid use in the previous 30 days * History of cardiac arrhythmia * History of heart disease (i.e., atrial fibrillation, congestive heart failure) * Presence of an implantable device with an electrical discharge (i.e., pacemaker) * History of epilepsy * BMI \> 50 * History of TENS use * Planned pain intervention outside standard of care OR pre-procedure use of non-standard pain medication
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Center for Women's Health and Midwifery
New Haven, Connecticut, 06519, United States
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Yale Family Planning Clinic
New Haven, Connecticut, 06519, United States
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