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Effects of Photobiomodulation on Pain and Sexual Function in Women With Dyspareunia: Randomized Clinical Trial
Sponsor: Federal University of Health Science of Porto Alegre
Summary
The goal of this clinical trial is to compare the effects of vulvar and intravaginal application of PBM compared to the sham group on pain and sexual function in women with dyspareunia . The main question \[s\] it aims to answer are: * What are the effects of vulvar and intravaginal application of photobiomodulation (PBM) compared to the sham group on the sexual function of women with dyspareunia in the immediate post-intervention moments and in follow-ups of 15, 30, 90 and 180 days? * What are the effects of vulvar and intravaginal application of photobiomodulation (PBM) compared to the sham group on pain in women with dyspareunia in the immediate post-intervention moments and in follow-ups of 15, 30, 90 and 180 days? Participants will The GPBM photobiomodulation group will receive, during the 8 days of intervention, application in 8 points (4 red and 4 infrared) in the vulvar region and 8 points (4 red and 4 infrared) in the intravaginal pelvic floor region of PBM while the GS group will receive simulation application of PBM in the same number of vulvar and intravaginal points, in the same places where it was applied in the GPBM group. To see if 8 applications of photobiomodulation are really capable of reducing pain and improving sexual function in women with dyspareunia
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2024-06
Completion Date
2027-08
Last Updated
2024-06-14
Healthy Volunteers
No
Conditions
Interventions
photobiomidulação
The volunteers in the GFBM group will undergo 8 sessions of a combined red and infrared laser protocol with 4J of infrared power and 4J of red power. Being applied at 8 points (4 red and 4 infrared) in the vulvar region and 8 points (4 red and 4 infrared) points in the intravaginal pelvic floor region. The MMO semiconductor laser device (GaA1As and InGaAlP) will be used with an area of the output laser beam at the NOZZLE of the laser pen of 3mm2 and wavelengths of 660nm (Red Laser) and 808nm (Infrared Laser) with a power of 100mW. The application will be carried out with the volunteers on a stretcher, in the supine position, gynecological position, with the knees and hips flexed and in abduction, feet supported on the stretcher.
Placebo
The placebo control will be administered using the same device as the GFBM, but without any therapeutic dose delivery. Furthermore, the irradiated sites and irradiation time will be the same as PBMT. Volunteers will receive a total dose of 0 J in placebo mode. This treatment was also carried out in 8 sessions.
Locations (1)
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil