Endometriosis
Conditions
Interventions
This is a randomized, controlled, double-blind, two-arm clinical trial. Experimental group: 15 women with chronic pelvic pain will receive active intravaginal photobiomodulation delivered with a speci
Sponsors
Faculdade de Ciências da Saúde do Trairi
Faculdade de Ciências da Saúde do Trairi
Eligibility
Sex/Gender
Female
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: Women aged 18 to 49 years who report chronic pelvic pain will be included in this study. Participants must report non-cyclical pain located in the pelvic region, with a duration of at least 3 months, and must be available to attend the in-person sessions according to the study schedule.
Exclusion criteria
Exclusion criteria: Women will be excluded if they present malignancy (cancer); epilepsy; cardiac arrhythmia; cognitive impairment; difficulty understanding instructions and/or using the assessment instruments; history of pelvic surgery within the past year; chronic infection; pregnancy; intact hymen. Participants included in the study must not be undergoing any other type of treatment for chronic pelvic pain, except for pharmacological treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of chronic pelvic pain, assessed using the Brief Pain Inventory (BPI). Pain intensity will be measured through the average pain, worst pain, and current pain scores, using a numerical rating scale from 0 to 10. Assessments will be conducted at baseline, at the 6th week of the intervention, and at the end of the 12-week period. A clinically significant reduction in pain scores is expected between the experimental group and the control group at the end of the treatment period.;Quality of life, assessed using the WHOQOL-BREF and the Endometriosis Health Profile-30 (EHP-30), administered at baseline, at the 6th week, and at the end of the 12th week. Scores will be analyzed across physical, psychological, social, and environmental domains, allowing the observation of changes in overall well-being. | — |
Secondary
| Measure | Time frame |
|---|---|
| Functionality, assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), administered at all three assessment points. This instrument will allow the evaluation of the impact of chronic pelvic pain on daily living activities and social participation.;Sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). The analysis will allow monitoring changes in sleep duration, efficiency, latency, and subjective perception of sleep quality, as well as assessing daytime sleepiness. Assessments will be conducted at baseline, at the 6th week, and at the end of the 12-week period.;Sexual function, assessed using the Female Sexual Function Index (FSFI), which evaluates desire, arousal, lubrication, orgasm, satisfaction, and pain related to sexual activity. Assessments will be conducted at baseline, at the 6th week, and at the end of the 12-week intervention, allowing the identification of potential improvements or changes in sexual function throughout the study.;Perception of the intervention and expectations will be assessed by asking participants which group they believe they were allocated to (EG, CG, or “do not know”), allowing the analysis of the effectiveness of blinding. Expectations regarding the intervention will also be evaluated using a 1 to 5 Likert scale, where higher scores indicate greater expected benefit. Finally, perceived improvement after the treatment will be measured using a 1 to 5 Likert scale, in which higher values indicate greater perceived improvement in clinical and functional outcomes. These data complement the objective measures and allow the assessment of the participant’s subjective experience and her perception of the intervention’s effectiveness. | — |
Countries
Brazil
Contacts
Public ContactVanessa Soares de Sousa
Faculdade de Ciências da Saúde do Trairi
Outcome results
None listed