The Effectiveness of an Intervention Based on the Consumption of Fresh Strawberries From the Huelva Region on Menstrual Pain and Menstrual Distress in Young University Students
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The purpose of this project is to know the effectiveness of an intervention based on the consumption of fresh strawberries from the Huelva region on menstrual pain and menstrual distress in young university students with primary dysmenorrhea, compared to a control group of students.
The participants with dysmenorrhea will be divided into two groups, the assignment will be random to the intervention group with strawberry intake for a month and comparing its effect with de control group. The results of the evaluations carried out prior, to the month and 2 months of the intervention will be compared.
详细描述
Dysmenorrhea is a prevalent problem among women of childbearing age; previous studies carried out among young university students have identified that it affects 74% of them. Dysmenorrhea can also be accompanied by the well-known menstrual distress, which has been estimated to affect between 75 and 94% of women. The symptoms included in menstrual distress are diverse, including irritability, nausea, vomiting, abdominal pain, general weakness or fatigue, among others. Dysmenorrhea and distress have a significant impact on the lives of women who suffer from it, affecting their social life, quality of life and academic and work performance.
The methods that women use to relieve dysmenorrhea are usually pharmacological, with NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and hormonal contraceptives, but these are not free of adverse effects, so more and more studies are investigating non-pharmacological methods to relieve pain. Menstrual distress is also being included as an object of study.
A healthy lifestyle has been shown to be beneficial in relieving primary dysmenorrhoea. In particular, exercise and eating at least 2 pieces of fruit per day have been identified as protective habits.
Most of the studies that evaluate food intake in women with dysmenorrhea are observational and the few clinical trials that exist are with small samples. Strawberries are rich in flavonoids and phenolic acids, giving them anti-inflammatory and antioxidant properties. Studies carried out with strawberries have shown their benefits against chronic inflammatory and cardiovascular diseases. For these reasons, it is necessary a clinical trial to evaluate the benefits of strawberry in relieving dysmenorrhea and menstrual distress.
Carrying out a clinical trial with strawberries is a challenge. Firstly, there is no consensus on the optimal dose that should be ingested to influence health biomarkers. On the other hand, the use of fresh strawberries involves a significant cost, in addition to the fact that it is a seasonal fruit, which is why the most of trials with strawberries are carried out with freeze-dried strawberry powder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The assignment to each group will be blind. It will be done through a computer application, which assigns random numbers to each participant.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous women
- •Suffer menstrual pain at least 1 time in the last 6 months or 3 times in the last year
- •Without a history of diagnosed gynecological pathology
- •Not taking hormonal contraception
- •Being enrolled at the University of Huelva for the academic year 2023/2024
排除标准
- •Those who do not meet the inclusion criteria
- •Being in the process of mobility during the months of study
- •Have had an abortion
- •Suffer from a problem that requires limiting the consumption of fruit or strawberries in their diet
- •Suffer from a chronic disease that causes pain
结局指标
主要结局
Pain intensity
时间窗: Change from baseline pain intensity at 1 month and 2 months.
Pain intensity will be evaluated with the Visual Analog Scale (VAS). This is a self-administered, single-item measurement scale. Located on a horizontal or vertical line 10 cm (100mm) long, whose values range from 0 ("no pain") to 10 ("the worst pain imaginable"). Participants will be asked to write down the maximum perceived pain during the first 3 days of menstruation.
Distress menstrual
时间窗: Change from baseline distress menstrual at 1 month and 2 months.
Menstrual distress will be assessed using the MEDI-Q scale, which will be validated in Spanish in a previous phase of this study. This questionnaire evaluates symptoms in the premenstrual, menstrual and intermenstrual phases through a total of 25 items. The score ranges between 0 (absence of symptoms that cause distress during menstruation in the last year) and 125 (presence of all symptoms in more than half of menstruations in the last 12 months).
次要结局
- Changes in Quality of life(Baseline, 1 month and 2 months.)
- Changes in menstrual pain management(Baseline, 1 month and 2 months.)
- Changes in absenteeism and presenteeism days(Baseline, 1 month and 2 months.)
- The impact on daily and academic activities(Baseline, 1 month and 2 months.)
- Changes menstrual issues(Baseline, 1 month and 2 months.)
- Anxiety State and Anxiety Trait(Baseline, 1 month and 2 months.)
- Perceived well-being(Baseline, 1 month and 2 months.)
- Sleep quality(Baseline, 1 month and 2 months.)
- Changes amount of bleeding(Baseline, 1 month and 2 months.)
研究者
Cynthia del Rocío Márquez Beltrán
PHD Student. Associate researcher. Nurse.
University of Huelva