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Bioptron Light Therapy for Dysmenorrhea in Obese Adolesences: RCT

A

Alaa Noureldeen Kora

Status

Begins enrollment in 1 month

Conditions

Obesity and Overweight
Dysmenorrhea Primary

Treatments

Device: bioptron light therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06992349
SU.REC.2024 (26 H)

Details and patient eligibility

About

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.

Enrollment

144 estimated patients

Sex

Female

Ages

16 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

144 participants in 2 patient groups

Group 1: women with BMI more than 30 and receive active bioptron©
Experimental group
Treatment:
Device: bioptron light therapy
Group 2: women with BMI between 18.5 to 25 and receive active bioptron©.
Experimental group
Treatment:
Device: bioptron light therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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