An interventional study of Bioptron Pro 1 Class II and Vitamin D in Dysmenorrhea, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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
398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.
This study's planned enrollment of 56 is close to the median of 60 across 333 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
All females will be clinically diagnosed by the gynecologist with primary dysmenorrhea.
B) Exclusion Criteria:
Participants will be excluded if they have:
lt will include 28 participants suffering from PD who will take vitamin D (vit D) supplementations for three consecutive menstrual cycles.
Other: Vitamin D
lt will include 28 participants suffering from PD who will take vitamin D (vit D) supplementations as in group A in addition to Bioptron for 20 min daily for 7 days before menstrual cycle along with the first three days of menstrual flow for three consecutive menstrual cycles.
Other: Bioptron Pro 1 Class II · Other: Vitamin D
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
All participants in both groups will take this supplements daily for 3 months
Pain intensity
The pain intensity will be assessed through VAS for both groups (A\&B) before and after the end of the treatment program (throughout three consecutive menstrual cycle) and follow up period . Each female will be asked to mark a point on the line between the extreme that is related to her pain intensity.
Time frame: Three months
Pressure pain threshold (PPT)
A pressure algometer will be used to measure pressure pain thresholds for all participants in both groups (A\&B) before and after the treatment program (throughout three consecutive menstrual cycles)
Time frame: three months
Plasma Progesterone level
Plasma progesterone for all participants in both groups (A\&B )will be analyzed by Enzyme-Linked Immunosorbent Assay (ELISA), using Cayman Chemical Reagent Company kits before and after the treatment program.
Time frame: Three months
Assessment of menstrual symptoms
The WaLIDD questionnaire: will be used to assess the symptoms of primary dysmenorrhea for all participants in both groups (A\&B) before the treatment and after the end of the treatment program (throughout three consecutive menstrual cycles and during the follow-up period).
Time frame: Three months
Quality of life enjoyment and satisfaction
The Quality-of-life enjoyment and satisfaction questionnaire Q-LES-QSF: will be used to assess health-related quality of life for all participants in both groups (A\&B) before the treatment program and after the end of the treatment program (throughout three consecutive menstrual cycles).
Time frame: Three months
Plan to share: No
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Cairo University