Role of transdermal magnesium to improve functional quality of life and wellness among collegiate females with Primary Dysmenorrhea- A randomized controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The main primary outcome to be assess will be menstrual pain on Wallid scale, functional activities of daily living with Barthel index scale and mental well-being by WHO-5 scale.
研究概览
简要总结
Primary dysmenorrhea (PD) is a common condition characterized by painful menstruation, typically involving suprapubic cramps radiating to the back and thighs. It is not associated with pelvic disease and typically begins after menarche, affecting 50-90% of women. PD can negatively impact quality of life (QoL), influencing daily activities, social interactions, and emotional well-being. The exact cause is not fully understood, but it is thought to involve increased prostaglandin release, which leads to uterine muscle contractions and pain. Magnesium has been suggested to reduce dysmenorrhea symptoms by acting as an analgesic and by influencing the NMDA receptor, reducing central sensitization and pain perception. However, while there has been research on magnesium and other treatments for PD, the specific role of transdermal magnesium has not been well-studied, particularly in improving QoL. Aim and Objectives: The aim of this study is to analyze the role of transdermal magnesium in improving functional QoL among college females with primary dysmenorrhea. Methodology: Study Design: Randomized, parallel group, active-controlled trial with a pre-post interventional design. Study Site: Galgotias University OPD E-Block. Sample Size: 72 participants, calculated using G Power with a 10% dropout rate. Screening: Self-structured questionnaire and WALLID Score to assess dysmenorrhea; patch test prior to intervention. Research Gap: While magnesium’s role in dysmenorrhea has been studied, the specific impact of transdermal magnesium on primary dysmenorrhea and its effect on QoL remains under-researched. Transdermal Magnesium Uses: Magnesium is believed to have various benefits, including aiding in muscle recovery, joint pain relief, PMS, and menstrual pain management. Regular use of transdermal magnesium can help alleviate cramps and other dysmenorrhea symptoms, potentially improving overall wellness. This study will contribute to filling the research gap by evaluating the effectiveness of transdermal magnesium in managing primary dysmenorrhea and its impact on quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •Participants must be females aged 18-30 with primary dysmenorrhea and a WALLID score above a specified threshold.
- •They should be willing to provide informed consent, attend intervention sessions, and complete follow-up assessments.
- •Participants must also be able to understand and communicate in the study language, follow instructions, and complete questionnaires.
- •A negative patch test with no irritation or burning from transdermal magnesium application is required.
排除标准
- •Participants will be excluded if they have a history of secondary dysmenorrhea (e.g., due to endometriosis or pelvic inflammatory disease), a WALLID score below a specified threshold, or are pregnant or planning to become pregnant during the study.
- •Those using hormonal contraceptives or medications affecting the menstrual cycle or pain perception within a specified time frame are also excluded.
- •Individuals with a history of chronic pelvic pain, psychiatric disorders, or current use of psychotropic medications are not eligible.
- •Participation in other dysmenorrhea-related interventions or clinical trials during the study period is prohibited.
- •Other exclusions include inability to comply with the protocol, medical conditions that pose safety risks, known allergies to magnesium or components of the transdermal formulation, and physical limitations preventing participation in pelvic floor exercises.
- •Participants who experience itching or burning during the patch test will also be excluded.
结局指标
主要结局
The main primary outcome to be assess will be menstrual pain on Wallid scale, functional activities of daily living with Barthel index scale and mental well-being by WHO-5 scale.
时间窗: Baseline (day 1) once a month during menstrual cycle for 6 months and once a month follow up for 3 months
次要结局
未报告次要终点
研究者
Dr Jyoti Sharma
Galgotias University