Effect of Bioptron on Primary Dysmenorrhea

Официальное название

Effect of Bioptron on Primary Dysmenorrhea: a Randomized Controlled Trial

Обзор

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.

Подробное описание

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

Вмешательства

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

Первичные конечные точки

• Pain intensity [Срок оценки: Three months]
• Pressure pain threshold (PPT) [Срок оценки: three months]

Вторичные конечные точки (3)

• Plasma Progesterone level [Срок оценки: Three months]
• Assessment of menstrual symptoms [Срок оценки: Three months]
• Quality of life enjoyment and satisfaction [Срок оценки: Three months]

Критерии участия

Критерии включения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Physical Therapy — Giza

Идентификаторы

NCT: NCT06729749 · P.T.REC/012/005313

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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