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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Pain in baseline — baseline
  VAS (Visual Analog Scale): Pain intensity was assessed using the Visual Analog Scale (VAS), a validated tool consisting of a 10-centimeter horizontal line ranging from 0 (no pain) to 10 (worst possible pain). Participants were instructed to mark a point on the line that best represented their perceived pain at each procedural step.
• Pain in five minutes — 5 minutes
  VAS (Visual Analog Scale): Pain intensity was assessed using the Visual Analog Scale (VAS), a validated tool consisting of a 10-centimeter horizontal line ranging from 0 (no pain) to 10 (worst possible pain). Participants were instructed to mark a point on the line that best represented their perceived pain at each procedural step.

Trial sites (1)

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