Clinical trial NCT06992349: Bioptron Light Therapy for Dysmenorrhea in Obese Adolesences: RCT
Official title: Evaluating the Efficacy of Bioptron° Light Therapy in Managing Primary Dysmenorrhea Among Obese Adolescence: Double Blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysmenorrhea Primary
Obesity and Overweight
Lead sponsor: Sinai University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 144
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: number of anatomical pain locations, pain range, number of days of pain during menstruation (and frequency of disabling pain to perform their activities.
timeFrame: At the end of Cycle 1 (each cycle is 28 days)".
Secondary outcomes:
measure: Numerical Rating Scale (NRS): is a single-item question that asks the patient to rate the pain on a scale of 0 to 10.
timeFrame: At the end of Cycle 1 (each cycle is 28 days)".
measure: Algometer is an objective measurement of the degree of pressure required to evoke a painful response over selected trigger points.
timeFrame: At the end of Cycle 1 (each cycle is 28 days)".
measure: The EuroQol-5 Dimension (EQ-5D), developed in 1990, is a most widely used generic tool to measure health-related quality of life.
timeFrame: At the end of Cycle 1 (each cycle is 28 days)".
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Sinai University
Study officials:
References: