Effect of Bioptron on Primary Dysmenorrhea

Cairo University (CU)

Status: Not yet enrolling

Conditions: Dysmenorrhea

Treatments: Other: Bioptron Pro 1 Class II; Other: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT06729749

P.T.REC/012/005313

Details and patient eligibility

About

This study will be conducted to determine the effect of bioptron on PD through the assessment of serum progesterone level, and pain level measured by pressure algometry in addition to evaluation of the symptoms of PD and its effect on girl's quality of life through valid and reliable questionnaires which will be of valuable benefits in the women's health fields.

Full description

All females will be randomly divided into two equal groups:

Group A (control group):

lt will include 28 participants suffering from PD taking vitamin D (vitamin D) supplements for three consecutive menstrual cycles.

Group B (study group):

lt will include 28 participants suffering from PD who will take vitamin D (vitamin D) supplementations as in group A in addition to Bioptron for 20 min daily for 7 days before the menstrual cycle along with the first three days of menstrual flow for three consecutive menstrual cycles.

All females will be given a full explanation of the study protocol and a consent form will be signed by each female before entry in the study

Enrollment: 56 estimated patients

Sex: Female

Ages: 18 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

All females will be clinically diagnosed by the gynecologist with primary dysmenorrhea.

• Self-reported history of PD, at least moderate pain due to menstrual cramps (>4 on VAS)
• They have moderate symptoms of PD on the WaILDD questionnaire, (5-12) Teheran et al., 2018).
• Their ages will be ranged from 18-24 years old.
• Their BMI will be less than 30 kg/m².
• Being a virgin.
• Having regular menstruation for the last 6 months (every 28-30 days with no intermittent bleeding).
• Voluntary acceptance to participate in the study.

B) Exclusion Criteria:

Participants will be excluded if they have:

• Musculoskeletal or neurological disorders.
• Patients with a history of phototherapy allergy.
• Professional athletes (Jill et al., 2012).
• Secondary dysmenorrhea pathology such as (endometriosis, fibroids, adenomyosis, and pelvic inflammatory disease)
• Menstrual irregularity.
• Using hormonal contraception (such as contraceptives or injections).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Group A (control group)

Active Comparator group

Description:

lt will include 28 participants suffering from PD who will take vitamin D (vit D) supplementations for three consecutive menstrual cycles.

Treatment:

Other: Vitamin D

Group B (study group)

Experimental group

Description:

lt will include 28 participants suffering from PD who will take vitamin D (vit D) supplementations as in group A in addition to Bioptron for 20 min daily for 7 days before menstrual cycle along with the first three days of menstrual flow for three consecutive menstrual cycles.

Treatment:

Other: Vitamin D

Other: Bioptron Pro 1 Class II