Bioptron Light Therapy for Dysmenorrhea in Obese Adolesences: RCT

Официальное название

Evaluating the Efficacy of Bioptron° Light Therapy in Managing Primary Dysmenorrhea Among Obese Adolescence: Double Blinded Randomized Control Trial

Обзор

Dysmenorrhea is the most common health problem in women in the reproductive age(Bakhsh et al., 2022). The primary dysmenorrhea starts shortly after the menarche the pain lasting 1 to 3 days that start just before or at the onset of menstruation with the absence of other gynecological symptoms (Itani et al., 2022). Primary dysmenorrhea can reduce the quality of life and social activities of women(Esan et al., 2024). There is a relationship between body mass composition and primary dysmenorrhea and as the value of body mass index and body fat percentages goes on increasing in females, the severity of primary dysmenorrhea also increased (Wu et al., 2022). BIOPTRON® Light therapy system is a device that contains an optical unit. This unit emits light with an electromagnetic spectrum produced by the sun, but without the ultraviolet rays and it is significant with four main characteristics which are Polarization, Polychromatic, Incoherence and low energy light (Raeissadat et al., 2014). The Purpose of the Study The aim of the study is to investigate the effect of bioptron© light therapy on primary dysmenorrhoea outcomes as pain and quality of life among obese adolescence.

Вмешательства

• Устройство bioptron light therapy
  BIOPTRON® Hyperlight is a proprietary, optimized blend of visible and infrared light properties that Bio-stimulate cells and speeding up the healing process of a wide range of medical diseases. Bioptron© light therapy has been utilized as a non-invasive treatment for wound healing, skin ulcers, and various musculoskeletal conditions(Abd Elhamid et al., 2020).

Первичные конечные точки

• number of anatomical pain locations, pain range, number of days of pain during menstruation (and frequency of disabling pain to perform their activities. [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)".]

Вторичные конечные точки (3)

• Numerical Rating Scale (NRS): is a single-item question that asks the patient to rate the pain on a scale of 0 to 10. [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)".]
• Algometer is an objective measurement of the degree of pressure required to evoke a painful response over selected trigger points. [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)".]
• The EuroQol-5 Dimension (EQ-5D), developed in 1990, is a most widely used generic tool to measure health-related quality of life. [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)".]

Критерии участия

Критерии включения

• 144 female adolescences suffering from primary dysmenorrhea pain determined according to the sample size calculation adapted from (Gu et al., 2022).
• They will be selected from the outpatient's clinic of the faculty of Physical Therapy Sinai University.
• Their chronological age ranged from 16 to 18 years old.

Критерии исключения

• Those who were taking anti-psychotic or anti-depressant medications, patients with any skin lesion or infection.
• Gynecological disorders included cervical cancer, ovarian tumors, endometriosis, uterine fibroids, polycystic ovarian syndrome, and other conditions that can affect menstruation.

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

• Sinai University — Ismailia

Идентификаторы

NCT: NCT06992349 · SU.REC.2024 (26 H)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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