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NCT Number: NCT06729749

Effect of Bioptron on Primary Dysmenorrhea

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.

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Key information

Age range

18 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Giza, Egypt, 12511

Location contact

Eman SA Eldeeb

CONTACT

0201012674761

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Bioptron Pro 1 Class II

Other

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

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

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. Plasma Progesterone level

    Time frame: Three months

    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.

  2. Assessment of menstrual symptoms

    Time frame: Three months

    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).

  3. Quality of life enjoyment and satisfaction

    Time frame: Three months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Eman SA Eldeeb

CONTACT

[email protected]

01012674761

Manal A El-Shafei, Lecturer

CONTACT

[email protected]

01220664518

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Bioptron on Primary Dysmenorrhea: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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