Evaluation of the Effectiveness of Web-Based Education on Premenstrual Syndrome (PMS) Symptoms and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Premenstrual Syndrome Scale (PMSS)
研究概览
简要总结
Digital solutions are becoming increasingly prevalent, addressing health concerns through innovative means has become imperative. Among these concerns, Premenstrual Syndrome (PMS) stands out as a significant challenge that affecting the physical and emotional well-being of women of reproductive age. Despite previous studies demonstrating the effectiveness of health education for PMS, there remains a gap in providing accessible and evidence-based interventions. The present study aims to fill this gap leveraging technology to deliver targeted information and support to women. For this reason, the purpose of this randomized controlled trial is to evaluate the effectiveness of a web-based health education in university students with PMS. The main questions it aims to answer are:
- Does web-based education lower the premenstrual symptoms in university students with PMS?
- Does web-based education improve the quality of life in university students with PMS?
Researchers compared web-based education to a control (no special intervention) to see if intervention works to management PMS. Intervention group participants received web-based education with weekly updates about PMS (definition, symptoms, treatment etc.) and management strategies for 4 weeks.
详细描述
The study was planned as a parallel, single-blind, randomized, controlled experimental study with a pretest-posttest design. The sample group of the research was the nursing department of a Faculty of Health Sciences in Pamukkale University. Eligibility was determined by the Premenstrual Syndrome Scale and personal information form. The sample size was calculated in the PS Power and Sample Size Calculations 3.1.6 program by using data from a previous study with a large effect size (α =0.05, d=0.86). Accordingly, it was found that at least 32 participants should be taken for each group to sampling for 80% power. To avoid possible data loss, all participants (n=74) determined to be eligible were included in the study. A simple randomization method was used in this study. Outcomes were measured at baseline, 4 weeks, and 12 weeks after the intervention began. Data were collected using the Premenstrual Syndrome Scale, Premenstrual Symptoms Impact Scale, System Usability Scale, and personal information form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Student
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PMS (PMSS score of 132+)
- •Normal menstrual cycle (21-35 days)
- •No oral contraceptives
- •No psychiatric problems or treatment
- •Active Internet use
- •Volunteering to participate in research
排除标准
- •Internet access problems
- •Website login issues
- •Unanswered survey questions
结局指标
主要结局
Premenstrual Syndrome Scale (PMSS)
时间窗: Change from baseline score at 4 and 12 weeks
The scale consists of 44 questions about experiences in the seven days before menstruation. Scores range from 44 to 220, with a total score above 132 indicating the presence of PMS. The scale contains nine subscales, each of which assesses a distinct aspect of PMS-related symptoms.
Premenstrual Symptoms Impact Scale (PMSIS)
时间窗: Change from baseline score at 4 and 12 weeks
The scale consists of six questions to evaluate the impact of PMS-related quality of life. Each question assesses the intensity of symptoms experienced during the "last premenstrual period". Total scores range from 6 to 30, with higher scores indicating worsening quality of life.
次要结局
- System Usability Scale (SUS)(At the end of the 4-week intervention)
研究者
Sevgi Özkan
Dean of Health Sciences Faculty, Professor
Pamukkale University