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Not yet recruiting NCT06992349

Bioptron Light Therapy for Dysmenorrhea in Obese Adolesences: RCT

No phase Interventional Dysmenorrhea Primary Obesity and Overweight

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 light therapy.
Who it may be relevant to
Registry conditions: Dysmenorrhea Primary, Obesity and Overweight. Basic parameters: 16 years — 18 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

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

Overview

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.

Interventions

  • Device 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).

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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
  • Sinai University — Ismailia

Identifiers

NCT: NCT06992349 · SU.REC.2024 (26 H)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗