Psychological and Physiological Effects of Lavender Herbal Tea in Women With Premenstrual Syndrome: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Premenstrual Syndrome Scale
研究概览
简要总结
Premenstrual syndrome (PMS) is a common but complex condition defined as a combination of emotional, psychological, and physical symptoms that occur during the luteal phase of the menstrual cycle, usually between 2 and 14 days before the onset of menstruation, and that diminish with menstruation. Epidemiological studies have reported that 80-90% of women experience premenstrual syndrome symptoms, with approximately 20-40% reported to affect daily functioning and relationships. Symptoms associated with PMS include irritability, mood swings, anxiety, depression, bloating, breast tenderness, and headaches. Pharmacological treatments such as selective serotonin reuptake inhibitors (SSRIs) and non-pharmacological methods such as dietary changes, exercise, and cognitive behavioral therapy are used in the management of PMS symptoms. Complementary herbal therapies are gaining increasing interest among individuals who want to avoid the side effects of traditional pharmacological agents. Various agents such as Vitex agnus-castus (chaste tree), Hypericum perforatum (St John's wort), evening primrose oil, and conventional herbal formulations have been studied in the literature. Vitex agnus-castus was found to be effective in relieving PMS symptoms by regulating hormonal balance. The antidepressant effects of yellow cantharone have been evaluated, but findings on its efficacy are inconsistent. Evening primrose oil shows particularly favorable effects on cyclic mastalgia. Lavender tea is known to reduce depression, anxiety, and mood swings. There are no clinical studies evaluating the effect of lavender tea on menstrual bleeding. A randomized controlled trial has shown that abdominal massage with lavender oil reduces the severity of menstrual pain. In this context, it may be a potential complementary herbal treatment to relieve PMS symptoms. Therefore, women with PMS will be divided into two groups. The intervention group will use 2 grams of lavender tea 2 times a day, morning and evening, for 9 days during 2 menstrual cycles (5 days before and 4 days after the estimated onset of menstruation). The control group will create a waiting list. The study data will be provided by 'Personal Information Form', 'Premenstrual Syndrome Scale', 'Depression Anxiety Stress-21 Scale', 'Premenstrual Syndrome Specific Quality of Life Scale', Visual Analogue Scale (VAS), and pad follow-up to monitor bleeding. SPSS 25.0 software will be used to analyze the data obtained from the study. Although the effects of lavender tea on PMS are promising, more clinical studies are needed to confirm its effectiveness. With this study, the need for clinical studies on the effectiveness of lavender tea will be met and a natural and complementary treatment method that can alleviate PMS symptoms will be tested.
详细描述
Premenstrual syndrome (PMS) is a clinical picture characterized by physical, psychological, and behavioral symptoms that occur during the luteal phase of the menstrual cycle, starting approximately one week before menstruation and decreasing with menstruation. The prevalence of PMS is quite high and it is reported that 50-90% of women experience at least one PMS symptom during the reproductive age. Physical symptoms of PMS include breast tenderness and bloating, headaches, muscle and joint pain, fatigue, appetite changes, sleep disturbances, and skin problems. Psychological symptoms include irritability, outbursts of anger, hypersensitivity, crying spells, difficulty focusing, and social isolation. Behavioral symptoms include overeating, increased alcohol and caffeine consumption, sleep irregularity, and decreased physical activity.
Pharmacological, non-pharmacological, and complementary approaches are applied in the management of PMS symptoms. Within the scope of pharmacological treatment, Selective Serotonin Reuptake Inhibitors (SSRIs) are widely used, especially in alleviating psychological symptoms. Non-pharmacological interventions include aerobic exercise, cognitive behavioral therapy, mindfulness-based approaches, diet and lifestyle changes. Dietary restriction of caffeine, sugar, and salt consumption has been reported to reduce PMS symptoms.
The trend towards complementary therapies is increasing due to the lower side effect profile compared to traditional pharmacological treatments. Various herbal agents such as Vitex agnus-castus (chaste tree), Hypericum perforatum (St John's wort), evening primrose oil, and traditional herbal formulations have been studied in the literature. Vitex agnus-castus was found to be effective in relieving PMS symptoms by regulating hormonal balance. The antidepressant effects of yellow cantharone have been evaluated, but findings on its efficacy are inconsistent. Evening primrose oil shows particularly favorable effects on cyclic mastalgia. Lavender tea has the potential to alleviate depression, anxiety, and mood swings, but there are no clinical studies evaluating the effect of lavender tea on menstrual bleeding. A randomized controlled trial showed that abdominal massage with lavender oil reduced the severity of menstrual pain. However, further research examining the effects of lavender tea specifically on the menstrual process is needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •No history of acute or chronic illness, Meeting the diagnostic criteria for PMS specified by ACOG, Over 18 years of age, No psychiatric distress and no treatment for psychiatric distress in the last 3 months, No (current or past) participation in psychotherapy for premenstrual symptoms, Not pregnant, Gynecological diseases (hysterectomy, oophorectomy, gynecological cancer, polycystic ovary syndrome, endometriosis, infertility) are among the inclusion criteria.
排除标准
- •Allergy to any herbal tea, food or medicine, Psychiatric illness or chronic illness, Use of psychiatric medication (such as anxiolytics and antidepressants), Regular medication use (such as antihypertensive, antidiabetic), Regular use of herbal teas or complementary medicines, Failure to meet the diagnostic criteria for PMS specified by ACOG, No regular menstruation in the last 3 months, Use of oral contraceptives during the last 3 months, Use of analgesics during menstruation while participating in the study.
结局指标
主要结局
Premenstrual Syndrome Scale
时间窗: 1. within 24 hours on the 4th day of menstruation (after the first 9 days of lavender tea use) 2. within 24 hours on the 4th day of menstruation (after the second 9 days of lavender tea use)
Depression Anxiety Stress-21 Scale
时间窗: 1. within 24 hours on the 4th day of menstruation (after the first 9 days of lavender tea use) 2. within 24 hours on the 4th day of menstruation (after the second 9 days of lavender tea use)
Premenstrual Syndrome Specific Quality of Life Scale
时间窗: 1. within 24 hours on the 4th day of menstruation (after the first 9 days of lavender tea use) 2. within 24 hours on the 4th day of menstruation (after the second 9 days of lavender tea use)
次要结局
- Visual Analogue Scale (VAS)(1. within 24 hours on the 4th day of menstruation (after the first 9 days of lavender tea use) 2. within 24 hours on the 4th day of menstruation (after the second 9 days of lavender tea use))
- Number of pads(1. within 24 hours on the 4th day of menstruation (after the first 9 days of lavender tea use) 2. within 24 hours on the 4th day of menstruation (after the second 9 days of lavender tea use))