Effect of Bioptron on Primary Dysmenorrhea

Not Applicable

Not yet recruiting

• Conditions: Dysmenorrhea

• Registration Number: NCT06729749
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed 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

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-07
• Study First Submitted QC: 2024-12-07
• Last Update Submitted: 2024-12-07
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Study Start: 2024-12-15
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 56

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity	Three months	The pain intensity will be assessed through VAS for both groups (A\&B) before and after the end of the treatment program (throughout three consecutive menstrual cycle) and follow up period . Each female will be asked to mark a point on the line between the extreme that is related to her pain intensity.
Pressure pain threshold (PPT)	three months	A pressure algometer will be used to measure pressure pain thresholds for all participants in both groups (A\&B) before and after the treatment program (throughout three consecutive menstrual cycles)

Secondary Outcome Measures

Name	Time	Method
Plasma Progesterone level	Three months	Plasma progesterone for all participants in both groups (A\&B )will be analyzed by Enzyme-Linked Immunosorbent Assay (ELISA), using Cayman Chemical Reagent Company kits before and after the treatment program.
Assessment of menstrual symptoms	Three months	The WaLIDD questionnaire: will be used to assess the symptoms of primary dysmenorrhea for all participants in both groups (A\&B) before the treatment and after the end of the treatment program (throughout three consecutive menstrual cycles and during the follow-up period).
Quality of life enjoyment and satisfaction	Three months	The Quality-of-life enjoyment and satisfaction questionnaire Q-LES-QSF: will be used to assess health-related quality of life for all participants in both groups (A\&B) before the treatment program and after the end of the treatment program (throughout three consecutive menstrual cycles).

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Giza, Egypt