Bioptron Light Therapy for Dysmenorrhea in Obese Adolesences: RCT

NCT ID: NCT06992349

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-08-31

Brief Summary

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.

Conditions

Dysmenorrhea Primary; Obesity and Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1: women with BMI more than 30 and receive active bioptron©

Group Type: EXPERIMENTAL

bioptron light therapy

Intervention Type: 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).

Group 2: women with BMI between 18.5 to 25 and receive active bioptron©.

Group Type: EXPERIMENTAL

bioptron light therapy

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alaa Noureldeen Kora

OTHER

Sponsor Role: lead

Responsible Party

Alaa Noureldeen Kora

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sinai University

Ismailia, , Egypt

Countries

Egypt

Facility Contacts

Alaa Kora, PhD

Role: primary

alaan.kora@gmail.com

01002701815

Other Identifiers

SU.REC.2024 (26 H)

Identifier Type: -

Identifier Source: org_study_id