PainNCT06984796
Photobiomodulation on Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD)
A study testing Photobiomodulation and Simulation of Photobiomodulation in people with Pain, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Photobiomodulation and Simulation of Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Mar 2026to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-50 years,
- Female,
- No preference regarding race or socioeconomic status,
- Nulliparous or multiparous.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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%.
Read the 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
- Being tested
- Photobiomodulation, Simulation of Photobiomodulation
- Keywords
- intrauterine device, photobiomodulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Also called low level laser therapy
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 PhotobiomodulationOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Simulation of Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 minutes
Secondary outcomes (18)
Pain in Pozzi Clamp Placement
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:
Pozzi Clamp Placement: A tenaculum is gently applied to the anterior lip of the cervix to align the uterine axis and provide cervical stabilization, facilitating safe access to the uterine cavity.
Measured: Immediately at the time of Pozzi clamp placement, assessed within 1 minute of application
Pain in Hysterometry
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:
Hysterometry: A sterile uterine sound is inserted to assess the direction and depth of the uterine cavity, which is essential for guiding correct IUD placement and minimizing complications.
Measured: Immediately at the time of hysterometry, assessed within 1 minute of the procedure
Pain in Intrauterine Device Insertion
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:
Intrauterine Device Insertion: The IUD is carefully introduced through the cervical canal and positioned at the uterine fundus. Once released, the device remains in place, and the strings are trimmed to ensure proper follow-up and future removal.
Measured: Immediately at the time of IUD insertion, assessed within 1 minute of the procedure
Pain in 15 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.
Measured: 15 minutes
Pain in 24 hours
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.
Measured: 24 hour
Pain in 48 hours
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.
Measured: 48 hour
Number of analgesics taken in baseline
Paracetamol intake was recorded at the T 380 copper IUD insertion baseline. At the beginning of the study, each participant will receive a blister pack of paracetamol (a pure analgesic) (Jóźwiak-Bebenista, 2014), which must be kept until the end of the study and will only be used in cases of pain. At the end of the study, the remaining number of tablets will be assessed as an additional pain measurement parameter. The analgesic used will be paracetamol 500 mg, to be taken only if necessary at a dose of one tablet every six hours. Participants will be asked to record in writing the number of tablets taken, along with the date and time of consumption. A monitoring procedure will be implemented to ensure adherence: participants must bring their blister pack to follow-up visits for verification.
Measured: Baseline
Number of analgesics taken in a total period of 48 hours
Paracetamol intake was recorded from baseline to 24 hours after the T 380 copper IUD insertion. At the beginning of the study, each participant will receive a blister pack of paracetamol (a pure analgesic), which must be kept until the end of the study and will only be used in pain cases. At the end of the study, the remaining number of tablets will be assessed as an additional pain measurement parameter. The analgesic used will be paracetamol 500 mg, to be taken only if necessary, at a dose of one tablet every six hours. Participants will be asked to record in writing the number of tablets taken, along with the date and time of consumption. A monitoring procedure will be implemented to ensure adherence: participants must bring their blister pack to follow-up visits for verification. Medication use will be tracked from baseline to 24 hours post-insertion.
Measured: 48 hours
Anxiety assessment in baseline
Generalized anxiety symptoms were evaluated at baseline in patients using the T 380 copper intrauterine device for contraception, through the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire. This self-administered tool, based on DSM-IV criteria, assesses the frequency of anxiety symptoms over the prior two weeks using a four-point Likert scale: 0 (never), 1 (several days), 2 (more than half the days), and 3 (nearly every day). Suitable for clinical and research use, and applicable in person or digitally, it takes about five minutes to complete. Total scores range from 0 to 21, with higher scores indicating more severe symptoms, categorized as follows: 0-4 (no anxiety), 5-9 (mild), 10-14 (moderate), and 15-21 (severe anxiety).
Measured: at Baseline
Anxiety assessment after 15 minutes of insertion
Generalized anxiety symptoms were evaluated at baseline in patients using the T 380 copper intrauterine device for contraception, through the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire. This self-administered tool, based on DSM-IV criteria, assesses the frequency of anxiety symptoms over the prior two weeks using a four-point Likert scale: 0 (never), 1 (several days), 2 (more than half the days), and 3 (nearly every day). Suitable for clinical and research use, and applicable in person or digitally, it takes about five minutes to complete. Total scores range from 0 to 21, with higher scores indicating more severe symptoms, categorized as follows: 0-4 (no anxiety), 5-9 (mild), 10-14 (moderate), and 15-21 (severe anxiety).
Measured: 15 minutes after the insertion
Quality of life assessment at baseline
Measured using the WHOQOL-Pain instrument at Baseline. The WHOQOL-Pain is an additional module of the WHOQOL-100, specifically developed to assess quality of life in individuals experiencing chronic pain. Each facet consists of four questions addressing different dimensions of the pain experience. Responses follow a five-point Likert scale, measuring intensity, capacity, evaluation, and frequency. Scores are converted to a 0 to 100 scale, allowing for a quantitative interpretation of pain levels and their impact on quality of life. The WHOQOL-Pain items are not integrated into the WHOQOL-100 and are applied separately at the end of the main questionnaire. This structure facilitates individualized analysis of pain-related facets, enabling a specific and detailed evaluation of physical chronic pain experiences.
Measured: at baseline
Quality of life assessment after 48 hours
Measured using the WHOQOL-Pain instrument from baseline to 48 hours after insertion. The WHOQOL-Pain is an additional module of the WHOQOL-100, specifically developed to assess quality of life in individuals experiencing chronic pain. Each facet consists of four questions addressing different dimensions of the pain experience. Responses follow a five-point Likert scale, measuring intensity, capacity, evaluation, and frequency. Scores are converted to a 0 to 100 scale, allowing for a quantitative interpretation of pain levels and their impact on quality of life. The WHOQOL-Pain items are not integrated into the WHOQOL-100 and are applied separately at the end of the main questionnaire. This structure facilitates individualized analysis of pain-related facets, enabling a specific and detailed evaluation of physical chronic pain experiences.
Measured: 48 hours after the insertion
Participant Satisfaction
Patient satisfaction with T 380 copper intrauterine device insertion for contraceptive purposes was assessed 15 minutes after the procedure using a dichotomous questionnaire adapted from Lopes et al. (2015). The instrument included three yes-or-no questions: (1) Was the insertion experience pleasant? (2) Would you undergo the procedure again in the future? (3) Would you recommend it to a friend? For each item, the response "yes" indicated satisfaction with the procedure, while "no" reflected dissatisfaction. Responses were scored as 1 for "yes" and 0 for "no", resulting in a total score ranging from 0 (maximum satisfaction) to 3 (maximum dissatisfaction). Higher scores indicated greater dissatisfaction with the procedure.
Measured: 15 minutes after insertion
Time required for abdominal discomfort relief (menstrual cramps)
The time required to relieve abdominal discomfort (menstrual cramps) was recorded from the day of the baseline assessment.
Measured: baseline
Time required for abdominal discomfort relief (menstrual cramps)
The time required to relieve abdominal discomfort (menstrual cramps) was recorded until the day the discomfort stopped. The patient will be asked after 48 h
Measured: 48 hours after insertion
Successful insertion
If IUD insertion fails, it will be assessed dichotomously (success/failure) from baseline to 24 hours after insertion, and verified by ultrasonography when necessary.
Measured: 48 hours after insertion
Adverse effects
Including uterine perforation, IUD displacement, abdominal pain, increased vaginal bleeding, and allergic reactions. An open-ended question will allow participants to report adverse effects, followed by a list of potential effects to help recall any unreported symptoms.
Measured: 48 hours
Side effects
Including cramps, mild pain, light bleeding, and tongue numbness. An open-ended question will be asked first, followed by a list of potential side effects for better recall.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start30 Mar 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
- Investigators
- Anna Carolina Nunes Ferraz, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984796
- Sponsor's protocol ID
- 7.367.867
- Status last verified
- Jul 2026
- First submitted
- 26 Apr 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferraz ACN, Traverzim MA, Makabe S, Machado GGA, Bussadori SK, Mesquita-Ferrari RA, Duran CCG, Motta LJ, Fernandes KPS, Horliana ACRT. Photobiomodulation for pain management during placement of the copper T 380 intrauterine device: Protocol for a randomized, double-blind controlled trial. PLoS One. 2026 May 28;21(5):e0349031. doi: 10.1371/journal.pone.0349031. eCollection 2026.
PubMed 42207758
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06984796
- Acronym / sponsor ID
- 7.367.867
- Conditions
- Pain
- Keywords
- intrauterine device, photobiomodulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation Group | Experimental | Device: PhotobiomodulationAll 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. |
| Simulation of Photobiomodulation Group | Sham comparator | Other: Simulation of PhotobiomodulationAll 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-50 years,
- Female,
- No preference regarding race or socioeconomic status,
- Nulliparous or multiparous.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationAlso: low level laser therapyThe 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. | Device | Photobiomodulation Group |
| Simulation of PhotobiomodulationThe 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. | Other | Simulation of Photobiomodulation Group |
Primary outcome
Pain in baseline
Time frame: 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
Time frame: 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.
18 secondary outcomes
Pain in Pozzi Clamp Placement
Time frame: Immediately at the time of Pozzi clamp placement, assessed within 1 minute of application
Pain in Hysterometry
Time frame: Immediately at the time of hysterometry, assessed within 1 minute of the procedure
Pain in Intrauterine Device Insertion
Time frame: Immediately at the time of IUD insertion, assessed within 1 minute of the procedure
Pain in 15 minutes
Time frame: 15 minutes
Pain in 24 hours
Time frame: 24 hour
Pain in 48 hours
Time frame: 48 hour
Number of analgesics taken in baseline
Time frame: Baseline
Number of analgesics taken in a total period of 48 hours
Time frame: 48 hours
Anxiety assessment in baseline
Time frame: at Baseline
Anxiety assessment after 15 minutes of insertion
Time frame: 15 minutes after the insertion
Quality of life assessment at baseline
Time frame: at baseline
Quality of life assessment after 48 hours
Time frame: 48 hours after the insertion
Participant Satisfaction
Time frame: 15 minutes after insertion
Time required for abdominal discomfort relief (menstrual cramps)
Time frame: baseline
Time required for abdominal discomfort relief (menstrual cramps)
Time frame: 48 hours after insertion
Successful insertion
Time frame: 48 hours after insertion
Adverse effects
Time frame: 48 hours
Side effects
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Derived from this study: PubMed 42207758Ferraz ACN, Traverzim MA, Makabe S, Machado GGA, Bussadori SK, Mesquita-Ferrari RA, Duran CCG, Motta LJ, Fernandes KPS, Horliana ACRT. Photobiomodulation for pain management during placement of the copper T 380 intrauterine device: Protocol for a randomized, double-blind controlled trial. PLoS One. 2026 May 28;21(5):e0349031. doi: 10.1371/journal.pone.0349031. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Carolina Nunes Ferraz principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation and Simulation of Photobiomodulation in people with Pain, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain in baseline (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06984796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.