Status:
NOT_YET_RECRUITING
Photobiomodulation on Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD)
Lead Sponsor:
University of Nove de Julho
Conditions:
Pain
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Unplanned pregnancy affects up to 65% of women in some regions of Brazil, contributing to unsafe abortions and maternal mortality. The copper IUD is an effective long-term contraceptive but is underus...
Detailed Description
Unplanned pregnancy affects up to 65% of women in some regions of Brazil, increasing the risks of unsafe abortions and contributing to maternal mortality. The copper IUD is an effective and long-lasti...
Eligibility Criteria
Inclusion
- Women aged 18-50 years,
- Female,
- No preference regarding race or socioeconomic status,
- Nulliparous or multiparous.
Exclusion
- Known or suspected pregnancy,
- Diagnosed with chronic pain,
- Active local infection,
- Use of any pain medication in the last 12 hours,
- Known contraindication for IUD insertion, including significant uterine cavity distortion, active pelvic inflammatory disease, or Wilson's disease,
- Allergy to copper,
- Unexplained abnormal uterine bleeding,
- Any condition affecting the lumbar region, such as active neoplasms, established osteomyelitis, or any pre-existing deep tissue lesions with necrosis or infection,
- History of photosensitivity.
Key Trial Info
Start Date :
January 30 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06984796
Start Date
January 30 2026
End Date
November 30 2026
Last Update
December 29 2025
Active Locations (1)
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1
Nove de Julho University (UNINOVE)
São Paulo, Brazil, 01504-001