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

NCT ID: NCT06984796

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-30
• Study Completion Date: 2026-11-30

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%.

Detailed Description

Unplanned pregnancy affects up to 65% of women in some regions of Brazil, increasing the risks of unsafe abortions and contributing to maternal mortality. The copper IUD is an effective and long-lasting contraceptive option, but its use is still limited in Brazil, covering only 4.4% of women of reproductive age. One of the main barriers is the pain associated with its insertion, which leads to fear and low adherence to the method. Since pain can be of visceral or somatic origin, traditional approaches such as anti-inflammatories and anesthetics have shown inconclusive results in reducing this discomfort. Photobiomodulation (PBM) exhibits anti-inflammatory and analgesic effects and has demonstrated positive results in managing pelvic pain in various clinical contexts, including labor and delivery. The objective of this study is to evaluate the efficacy of PBM as a preemptive analgesic method during the insertion of the T 380 copper IUD. A randomized, double-blind clinical trial will be conducted with 72 participants randomly allocated into an experimental group (n=36) - active PBM and a control group (n=36) - PBM simulation. Patients will follow the IUD insertion protocol as outlined in the Ministry of Health guidelines. Pain will be assessed at different time points using the Visual Analog Scale (VAS) during the insertion phases (Pozzi, hysterometry, and IUD insertion), at 5 and 15 minutes, and at 24 and 48 hours after IUD insertion.

Additionally, analgesic use and quality of life (as measured by the WHOQOL-100) will be assessed over 48 hours, along with anxiety levels (as measured by the GAD-7), satisfaction with the procedure immediately after insertion (at 15 minutes), and adverse and side effects within 48 hours. The duration of pain, in hours, from the moment of IUD insertion until its resolution, will also be evaluated, as well as the success rate of the procedure. Statistical analysis will be performed using SPSS software version 24.0, with a significance level of 5% (p < 0.05). Data normality will be assessed using the Shapiro-Wilk test. Student's t-test or the Mann-Whitney test will be used for continuous variables, while the chi-square test or Fisher's exact test will be applied for categorical variables. Pain will be analyzed using the Friedman test, and logistic regression will be used to evaluate associations between groups and adverse effects. Statistical analysis will be performed with a significance level of 5%. Data normality will be assessed using the Shapiro-Wilk test. For pain analysis (VAS) and variables such as anxiety and quality of life, the Friedman test will be applied. Analgesic use will be evaluated using a repeated measures analysis of variance (ANOVA). Adverse effects will be analyzed using logistic regression. The time to resolve abdominal discomfort will be estimated using Kaplan-Meier analysis, and IUD insertion success will be compared using the chi-square test.

Conditions

Pain

Keywords

intrauterine device; photobiomodulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Photobiomodulation Group

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.

Group Type: EXPERIMENTAL

Photobiomodulation

Intervention Type: 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.

Simulation of Photobiomodulation Group

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.

Group Type: SHAM_COMPARATOR

Simulation of Photobiomodulation

Intervention Type: 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.

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

low level laser therapy

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Anna Carolina Ratto Tempestini Horliana

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Carolina Nunes Ferraz

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

Nove de Julho University (UNINOVE)

São Paulo, , Brazil

Countries

Brazil

Central Contacts

ANNA CAROLINA N FERRAZ, PhD student

Role: CONTACT

Phone: 11996324513

Email: Anna Carolina Nunes Ferraz <annacarolina1984@gmail.com>

Anna Carolina Ratto Tempestini Horliana, PhD

Role: CONTACT

Phone: 11948002288

Email: annacrth@gmail.com

Other Identifiers

7.367.867

Identifier Type: -

Identifier Source: org_study_id