Photobiomodulation on Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD)

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%.

NCT Number	NCT06984796
Lead Sponsor	University of Nove de Julho
Conditions	Pain
Enrollment	72 participants
Start Date	2026-03-30
Primary Completion	2027-10-30 (estimated)
Study Completion	2027-10-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-29