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Not yet recruiting NCT06729749

Effect of Bioptron on Primary Dysmenorrhea

No phase Interventional Dysmenorrhea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bioptron Pro 1 Class II, Vitamin D.
Who it may be relevant to
Registry conditions: Dysmenorrhea. Basic parameters: 18 years — 24 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Bioptron on Primary Dysmenorrhea: a Randomized Controlled Trial

Overview

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

Interventions

  • 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,
  • Other Vitamin D
    All participants in both groups will take this supplements daily for 3 months

Primary outcome measures

  • Pain intensity [Time frame: Three months]
  • Pressure pain threshold (PPT) [Time frame: three months]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Inclusion criteria

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.
  • Having regular menstruation for the last 6 months (every 28-30 days with no intermittent bleeding).
  • Voluntary acceptance to participate in the study.

B) 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Physical Therapy — Giza

Identifiers

NCT: NCT06729749 · P.T.REC/012/005313

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗