Bioptron Light Therapy for Dysmenorrhea in Obese Adolesences: RCT
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-18
SponsorAlaa Noureldeen Kora
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
bioptron light therapy
DeviceBIOPTRON® 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).
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Group 1: women with BMI more than 30 and receive active bioptron©Experimental treatment 1 intervention
Group B: Group 2: women with BMI between 18.5 to 25 and receive active bioptron©.Experimental treatment 1 intervention
Trial outcomes
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 contacts
Click on the lead sponsor to view all of their trials.
Alaa Noureldeen Kora
Lead sponsor
Sinai University
Sponsor institution
Source ClinicalTrials.gov
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