About this trial
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
Qualifiers
Women aged 18-50 years,
Female,
No preference regarding race or socioeconomic status,
Nulliparous or multiparous.
Disqualifiers
Known or suspected pregnancy,
Diagnosed with chronic pain,
Active local infection,
Use of any pain medication in the last 12 hours,
Trial design
Treatments tested in this trial
- Photobiomodulation
- Simulation of Photobiomodulation