Clinical trial NCT06984796: Photobiomodulation on Pain Perception During the Insertion of the T 380 Copper Intrauterine Device (IUD)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Keywords: intrauterine device
photobiomodulation
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain in baseline
timeFrame: baseline
measure: Pain in five minutes
timeFrame: 5 minutes
Secondary outcomes:
measure: Pain in Pozzi Clamp Placement
timeFrame: Immediately at the time of Pozzi clamp placement, assessed within 1 minute of application
measure: Pain in Hysterometry
timeFrame: Immediately at the time of hysterometry, assessed within 1 minute of the procedure
measure: Pain in Intrauterine Device Insertion
timeFrame: Immediately at the time of IUD insertion, assessed within 1 minute of the procedure
measure: Pain in 15 minutes
timeFrame: 15 minutes
measure: Pain in 24 hour
timeFrame: 24 hour
measure: Pain in 48 hour
timeFrame: 48 hour
measure: Number of analgesics taken in baseline
timeFrame: Baseline
measure: Number of analgesics taken in a total periodo of 48 hours
timeFrame: 48 hours
measure: Anxiety assessment in baseline
timeFrame: at Baseline
measure: Anxiety assessment after 15 minutes of insertion
timeFrame: 15 minutes after the insertion
measure: Quality of life assessment at baseline
timeFrame: at baseline
measure: Quality of life assessment after 48 hours
timeFrame: 48 hours after the insertion
measure: Participant Satisfaction
timeFrame: 15 minutes after insertion
measure: Time required for abdominal discomfort relief (menstrual cramps)
timeFrame: baseline
measure: Time required for abdominal discomfort relief (menstrual cramps)
timeFrame: 48 hours after insertion
measure: Ultrasound verification for successful insertion
timeFrame: 48 hours after insertion
measure: Adverse effects
timeFrame: 48 hours
measure: Side effects
timeFrame: 48 hours
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University (UNINOVE)
Study officials:
affiliation: University of Nove de Julho
name: Anna Carolina Nunes Ferraz
role: PRINCIPAL_INVESTIGATOR
References: