Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
56 participants
INTERVENTIONAL
2024-12-15
2025-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A (control group)
lt will include 28 participants suffering from PD who will take vitamin D (vit D) supplementations for three consecutive menstrual cycles.
Vitamin D
All participants in both groups will take this supplements daily for 3 months
Group B (study group)
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.
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
Vitamin D
All participants in both groups will take this supplements daily for 3 months
Interventions
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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
Vitamin D
All participants in both groups will take this supplements daily for 3 months
Eligibility Criteria
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Inclusion Criteria
* Self-reported history of PD, at least moderate pain due to menstrual cramps (\>4 on VAS)
* They have moderate symptoms of PD on the WaILDD questionnaire, (5-12) Teheran et al., 2018).
* Their ages will be ranged from 18-24 years old.
* Their BMI will be less than 30 kg/m².
* Being a virgin.
* Having regular menstruation for the last 6 months (every 28-30 days with no intermittent bleeding).
* Voluntary acceptance to participate in the study.
Exclusion Criteria
* Musculoskeletal or neurological disorders.
* Patients with a history of phototherapy allergy.
* Professional athletes (Jill et al., 2012).
* Secondary dysmenorrhea pathology such as (endometriosis, fibroids, adenomyosis, and pelvic inflammatory disease)
* Menstrual irregularity.
* Using hormonal contraception (such as contraceptives or injections).
18 Years
24 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Eman Saleh Ahmed Eldeep
Master student at Faculty of Physical Therapy, Cairo University
Principal Investigators
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Doaa A Osman
Role: STUDY_CHAIR
Cairo University
Locations
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Faculty of Physical Therapy
Giza, Egypt, Egypt
Countries
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Central Contacts
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Facility Contacts
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Eman SA Eldeeb
Role: primary
Other Identifiers
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P.T.REC/012/005313
Identifier Type: -
Identifier Source: org_study_id