DysmenorrheaNCT06729749
Effect of Bioptron on Primary Dysmenorrhea
A study testing Bioptron Pro 1 Class II and Vitamin D in people with Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Bioptron Pro 1 Class II and Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All females will be clinically diagnosed by the gynecologist with primary dysmenorrhea.
- 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.
Show all 16Show fewer
- 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:
- Participants will be excluded if they have:
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Physical Therapy
Giza, Egypt, 12511
Eman SA Eldeeb, 0201012674761
About this study
Official title: Effect of Bioptron on Primary Dysmenorrhea: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Bioptron Pro 1 Class II, Vitamin D
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioptron Pro 1 Class IIOther
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 DOther
All participants in both groups will take this supplements daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group A (control group) | Active comparator | lt will include 28 participants suffering from PD who will take vitamin D (vit D) supplementations for three consecutive menstrual cycles. Receives: Other: Vitamin D |
| Group B (study group) | Experimental | 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. Receives: Other: Bioptron Pro 1 Class II; Other: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: three months
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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).
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Saleh Ahmed Eldeep, Cairo University
- Investigators
- Doaa A Osman, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729749
- Sponsor's protocol ID
- P.T.REC/012/005313
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bioptron on Primary Dysmenorrhea: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06729749
- Acronym / sponsor ID
- P.T.REC/012/005313
- Conditions
- Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (control group) | Active comparator | Other: Vitamin Dlt will include 28 participants suffering from PD who will take vitamin D (vit D) supplementations for three consecutive menstrual cycles. |
| Group B (study group) | Experimental | Other: Bioptron Pro 1 Class II, Other: Vitamin Dlt 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- All females will be clinically diagnosed by the gynecologist with primary dysmenorrhea.
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioptron Pro 1 Class IIBioptron 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 | Group B (study group) |
| Vitamin DAll participants in both groups will take this supplements daily for 3 months | Other | Group A (control group), Group B (study group) |
Primary outcome
Pain intensity
Time frame: Three months
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.
Pressure pain threshold (PPT)
Time frame: three months
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)
3 secondary outcomes
Plasma Progesterone level
Time frame: Three months
Assessment of menstrual symptoms
Time frame: Three months
Quality of life enjoyment and satisfaction
Time frame: Three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doaa A Osman study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioptron Pro 1 Class II and Vitamin D in people with Dysmenorrhea, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman SA Eldeeb (01012674761, emansalehpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.