Bioptron Light Therapy for Dysmenorrhea in Obese Adolesences: RCT

NCT06992349 | Not Yet Recruiting DMC

• 1 other identifier: SU.REC.2024 (26 H)
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  At the end of Cycle 1 (each cycle is 28 days)".

Secondary Outcomes (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.

  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.

  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.

  At the end of Cycle 1 (each cycle is 28 days)".

Study Arms (2)

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

EXPERIMENTAL

Device: bioptron light therapy

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

EXPERIMENTAL

Device: bioptron light therapy

Interventions

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).

Group 1: women with BMI more than 30 and receive active bioptron©; Group 2: women with BMI between 18.5 to 25 and receive active bioptron©.

Eligibility Criteria

• Age: 16 Years - 18 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alaa Noureldeen Kora: lead

Study Sites (1)

Sinai University

Ismailia, 11749, Egypt

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: May 28, 2025
• Study Start: August 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)