Impact Of Multimodal Intervention On Adolescent Girls With Primary Dysmenorrhea Along With Caregiver Support: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- WaLIDD Score
研究概览
简要总结
Primary dysmenorrhea, affecting 50%–87.8% of adolescent girls in India, causes significant pain and disrupts daily activities and quality of life. Despite its high prevalence, it is often poorly managed due to a lack of awareness, stigma, and misconceptions, with many girls enduring symptoms silently. Caregivers, especially mothers, greatly influence how girls perceive and manage menstrual pain, yet they often have limited or incorrect knowledge.
This study aims to evaluate the effectiveness of a multimodal intervention combining education, lifestyle modifications, and non-pharmacological strategies to reduce dysmenorrhea symptoms, while also assessing the impact of caregiver support. Participants will be divided into an experimental group (receiving structured sessions with caregiver involvement) and a control group (receiving pamphlet-based education only). By actively involving caregivers and educating both groups, the study seeks to improve symptom management and enhance the overall quality of life of adolescent girls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adolescent girls aged 12 to 16 years.
- •Adolescent girls with Moderate – Severe menstrual pain on WaLIDD score.
- •Participants should have a history of regular menstrual cycles (every 21 to 35 days) for at least three months prior to the study.
- •Education level of the caregiver.
- •A willingness of the adolescent girl to take part in the research.
- •Willingness of mothers or primary female caregivers to participate in the educational and exercise component of the intervention.
排除标准
- •Adolescent girls who are not willing to participate in the study.
- •Girls with dysmenorrhea resulting from identifiable medical conditions (e.g., endometriosis, pelvic inflammatory disease, uterine fibroids) will be excluded.
- •Participants who have engaged in other treatments for dysmenorrhea (such as alternative therapies) within the last three months prior to the study.
- •Girls currently using hormonal contraceptives or other medications that affect menstrual symptoms.
- •Physical limitations that would prevent participation in stretching, exercise, or yoga components of the intervention.
结局指标
主要结局
WaLIDD Score
时间窗: The WaLIDD score will be recorded at baseline and then after each menstrual cycle following each monthly intervention session, for a total of three cycles
次要结局
- EQ-5D(The EQ-5D will be assessed at baseline and at 12 weeks, that is, upon completion of the intervention following the final menstrual cycle. The pre and post scores will be then evaluated.)
研究者
Harshitha V K
Nitte Institute Of Physiotherapy