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

NCT06984796 | Not Yet Recruiting DMC

• 1 other identifier: 7.367.867
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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%.

Conditions

Pain

Keywords

intrauterine device; photobiomodulation

Outcome Measures

Primary Outcomes (2)

• Pain in 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.

  baseline

• Pain in five 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.

  5 minutes

Secondary Outcomes (18)

• Pain in Pozzi Clamp Placement

  Immediately at the time of Pozzi clamp placement, assessed within 1 minute of application

• Pain in Hysterometry

  Immediately at the time of hysterometry, assessed within 1 minute of the procedure

• Pain in Intrauterine Device Insertion

  Immediately at the time of IUD insertion, assessed within 1 minute of the procedure

• Pain in 15 minutes

  15 minutes

• Pain in 24 hours

  24 hour

Study Arms (2)

Photobiomodulation Group

EXPERIMENTAL

All participants will undergo the same Intrauterine Device insertion procedure. For irradiation, a Light Emitting Diode panel from the brand Sportlux® (Brazil, SP) will be used, with the following specifications. Photobiomodulation in the experimental group will be administered using 132 Light Emitting Diodes, with 660 nm and 850 nm wavelengths, 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.

Device: Photobiomodulation

Simulation of Photobiomodulation Group

SHAM COMPARATOR

All participants in this group will undergo the conventional Intrauterine Device insertion procedure, as previously described. They will receive a simulation of photobiomodulation and will be treated identically to the Experimental Group. The researcher responsible for the photobiomodulation application will simulate irradiation by positioning the device in the exact location as in the Experimental 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.

Other: Simulation of Photobiomodulation

Interventions

Photobiomodulation DEVICE

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.

Also known as: low level laser therapy

Photobiomodulation Group

Simulation of Photobiomodulation OTHER

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.

Simulation of Photobiomodulation Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-50 years,
• Female,
• No preference regarding race or socioeconomic status,
• Nulliparous or multiparous.

You may not qualify if:

• Known or suspected pregnancy,
• Diagnosed with chronic pain,
• Active local infection,
• Use of any pain medication in the last 12 hours,
• Known contraindication for IUD insertion, including significant uterine cavity distortion, active pelvic inflammatory disease, or Wilson's disease,
• Allergy to copper,
• Unexplained abnormal uterine bleeding,
• Any condition affecting the lumbar region, such as active neoplasms, established osteomyelitis, or any pre-existing deep tissue lesions with necrosis or infection,
• History of photosensitivity.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University (UNINOVE)

São Paulo, 01504-001, Brazil

Location

MeSH Terms

Conditions

Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Anna Carolina Nunes Ferraz

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ANNA CAROLINA N FERRAZ, PhD student

CONTACT

11996324513; Anna Carolina Nunes Ferraz <annacarolina1984@gmail.com>

Anna Carolina Ratto Tempestini Horliana, PhD

CONTACT

11948002288; annacrth@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 22, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

BR (1)