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Clinical Trial

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

NCT: NCT06984796 · ENROLLING_BY_INVITATION

NCT IDNCT06984796
StatusENROLLING_BY_INVITATION
Start Date2026-03-30
Completion2027-10-30
SponsorUniversity of Nove de Julho (OTHER)
First posted
Last updated

Brief 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%.

Frequently Asked Questions

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

Photobiomodulation on Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD) is a clinical trial registered under NCT06984796. Current status: ENROLLING_BY_INVITATION.

What is the status of NCT06984796?

The current status of NCT06984796 (Photobiomodulation on Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD)) is: ENROLLING_BY_INVITATION.

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

Photobiomodulation on Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD) started on 2026-03-30.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.