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Enrolling By Invitation
NCT06984796
Photobiomodulation on Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD)
Conditions: Pain
Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 72
Sponsor: University of Nove de Julho
Location: Nove de Julho University (UNINOVE) São Paulo
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 underused, with only 4.4% of women of reproductive age using it. One barrier is the pain during insertion, leading to low adherence. Photobiomodulation (PBM), which has anti-inflammatory and analgesic effects, may offer a solution. This study aims to assess PBM's efficacy as a preemptive analgesic during copper IUD insertion in a randomized, double-blind trial involving 72 participants. The experimental group (n=36) will receive active PBM, while the control group (n=36) will receive PBM simulation. Pain will be measured using the Visual Analog Scale (VAS) at multiple time points, and additional outcomes include analgesic use, quality of life (WHOQOL-100), anxiety (GAD-7), satisfaction, and adverse effects. Statistical analysis will include tests such as the Friedman test, logistic regression, and ANOVA, with a significance level of 5%.
Eligibility Criteria
Inclusion Criteria:
* Women aged 18-50 years,
* Female,
* No preference regarding race or socioeconomic status,
* Nulliparous or multiparous.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT06984796). StuddyBuddy aggregates publicly available trial information.