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NCT Number: NCT06992349

Bioptron Light Therapy for Dysmenorrhea in Obese Adolesences: RCT

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.

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Key information

Age range

16 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Bioptron Light Therapy

Device

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 outcomes

  1. 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 outcomes

  1. 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)".

  2. 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)".

  3. 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)".

Sponsors and collaborators

Lead sponsor

Alaa Noureldeen Kora

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 28, 2025
Registry last updated
May 28, 2025

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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