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Effect of Bioptron on Primary Dysmenorrhea

ConditionDysmenorrhea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-24
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bioptron Pro 1 Class II

    Other intervention

    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

    Other intervention

    All participants in both groups will take this supplements daily for 3 months

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Group A (control group)Active comparator 1 intervention
Group B: Group B (study group)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: