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Photobiomodulation on Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD)
Sponsor: University of Nove de Julho
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%.
Official title: Effect of Photobiomodulation on Reducing Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD) for Contraception: a Randomized Controlled Clinical Study
Key Details
Gender
FEMALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2026-03-30
Completion Date
2027-05-30
Last Updated
2026-02-04
Healthy Volunteers
Yes
Conditions
Interventions
Photobiomodulation
The irradiated region will cover the lumbar and thoracic spine, specifically from T10 to L4, using the Light Emitting Diode panel in a vertical orientation. Photobiomodulation in the experimental group will be administered using 132 Light Emitting Diodes with wavelengths of 660 nm and 850 nm, applied in contact mode. Each Light Emitting Diode has an emission area of 0.5 cm², with an application time of 20 minutes, an irradiance of 16 mW/cm², and an energy delivery of 4.8 J per Light Emitting Diode, resulting in a radiant exposure of 9.6 J/cm².
Simulation of Photobiomodulation
The researcher responsible for the photobiomodulation application will simulate irradiation by positioning the device in the exact location as in the Photobiomodulation Group; however, the equipment will remain turned off. To prevent participants from identifying the group to which they belong, the device's activation sound (beep) will be pre-recorded and played during the application.
Locations (1)
Nove de Julho University (UNINOVE)
São Paulo, Brazil