NCT06729749

Effect of Bioptron on Primary Dysmenorrhea

Effect of Bioptron on Primary Dysmenorrhea: a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted to determine the effect of bioptron on PD through the assessment of serum progesterone level, and pain level measured by pressure algometry in addition to evaluation of the symptoms of PD and its effect on girl's quality of life through valid and reliable questionnaires which will be of valuable benefits in the women's health fields.

Detailed description

All females will be randomly divided into two equal groups: Group A (control group): lt will include 28 participants suffering from PD taking vitamin D (vitamin D) supplements for three consecutive menstrual cycles. Group B (study group): lt will include 28 participants suffering from PD who will take vitamin D (vitamin D) supplementations as in group A in addition to Bioptron for 20 min daily for 7 days before the menstrual cycle along with the first three days of menstrual flow for three consecutive menstrual cycles. All females will be given a full explanation of the study protocol and a consent form will be signed by each female before entry in the study

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
OTHER	Bioptron Pro 1 Class II	Bioptron Pro 1 Class II: Made by Bioptron AG, Wollerau, Switzerland, a device with a floor stand emits a polarized light lamp. The device has an ergonomic table stand that can be combined with a functional floor stand, allowing flexible use in domestic and professional environments. easily adjustable height and head inclination and the ability to rotate the device head up to 360 allow a convenient usage of nearly any position. Treatments can easily be timed by a control panel down to 30 seconds, an integrated distance rod ensures the recommended distance from the skin surface It will be used for the treatment procedures for all participants in group B only with the following parameters, Wavelengths ranging from 480-3400 nm, Degree of polarization \>95% (590 - 1550 nm), Specific power density Av. 40 mW/cm2 Light energy per minute av.2.4 J/cm2, Light Intensity per min. 10.000 lux, Weight without stand 3.4 kg and Weight with stand7.8 kg ,Energy consumption in sleep mode0.5
OTHER	Vitamin D	All participants in both groups will take this supplements daily for 3 months

Timeline

• Start date: 2024-12-15
• Primary completion: 2025-06-15
• Completion: 2025-06-30
• First posted: 2024-12-11
• Last updated: 2024-12-11

Locations

1 site across 1 country: Egypt