The Effect of Mindfulness Practice on Coping With Primary Dysmenorrhea on Pain and Anxiety Level
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- VAS Pain Scale
研究概览
简要总结
The aim of this project is to determine the effect of mindfulness practice to cope with dysmenorrhea on pain and anxiety levels. The project will be carried out in a semi-randomized controlled manner. It will be applied to 100 students with dysmenorrhea (100 students by increasing by 10%, taking into account the losses that may occur in the 90 students determined in the sample calculation). Students who meet the inclusion criteria and approve of participating in the project will be given a pre-test before the application. 'Introductory Information Form', 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the pre-test. After the pre-test, mindfulness practice will be applied for 8 weeks (1 day/120 minutes per week). At the end of 8 weeks, an intermediate test will be performed in the first 3 days of the first menstrual cycle. After the mid-term test, students will practice mindfulness on their own with the brochures provided. Motivational messages will be sent to students for mindfulness practice, starting 3 days before their cycle. The final test will be administered 3 months after the intermediate test. 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the mid-test and post-test.
详细描述
Dysmenorrhea is a gynecological condition that negatively affects the lives of more than half of women during menstruation. The severity of dysmenorrhea can be mild, moderate or high. Dysmenorrhea negatively affects women's social relations, daily lives, business lives, academic achievements and quality of life. Pharmacological and non-pharmacological treatments are used in its treatment. Among the non-pharmacological methods used in the treatment of dysmenorrhea, methods such as aromatherapy, yoga, massage, regular exercise, acupuncture, acupressure, TENS and cognitive behavioral therapy have been used. Mindfulness, one of the cognitive behavioral treatment methods, reduces stress, anxiety and depression in women. The aim of this project is to determine the effect of mindfulness practice to cope with dysmenorrhea on pain and anxiety levels. The project will be carried out in a semi-randomized controlled manner. It will be applied to 100 students with dysmenorrhea (100 students by increasing by 10%, taking into account the losses that may occur in the 90 students determined in the sample calculation). Students who meet the inclusion criteria and approve of participating in the project will be given a pre-test before the application. 'Introductory Information Form', 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the pre-test. After the pre-test, mindfulness practice will be applied for 8 weeks (1 day/120 minutes per week). At the end of 8 weeks, an intermediate test will be performed in the first 3 days of the first menstrual cycle. After the mid-term test, students will practice mindfulness on their own with the brochures provided. Motivational messages will be sent to students for mindfulness practice, starting 3 days before their cycle. The final test will be administered 3 months after the intermediate test. 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the mid-test and post-test.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The determination of which university would be included in the control and experimental groups in the research was made through a randomization method. The selection was done blindly by an independent academician unrelated to the research. As a result of the randomization, the control group and the experimental groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being over 18 years old,
- •Being literate,
- •Having dysmenorrhea,
- •Volunteering to participate in the study,
- •Participating in mindfulness practice for 8 weeks,
- •Not using any pharmacological or non-pharmacological methods,
- •Studying at Bartin University
排除标准
- •Not being a university student
- •Not experiencing dysmenorrhea
- •Not attending at least two mindfulness practices
研究组 & 干预措施
Control Group
Students in the control group will not be given any application. A pre-test will be administered before starting the study, an interim test will be applied 8 weeks after the pre-test, and a post-test will be applied 3 months after the interim test. After the study is over, mindfulness will be applied to the students in the control group.
干预措施: Will not be given any application (Other)
Mindfulness group
Students who agree to participate in the research will be met with students in a quiet room of the school by making an appointment. Individuals will be pre-tested. Mindfulness will be applied within the first 3 days of the menstrual period. After continuing the training for 8 weeks, an interim test will be applied. After 3 months, the final test will be applied
干预措施: Mindfulness training (Procedure)
结局指标
主要结局
VAS Pain Scale
时间窗: five month
The scale consists of a horizontal line of 100 mm in length. At the left end of the line is the phrase "No pain" or "The pain is completely gone", while at the right end is the phrase "Unbearable pain" or "No reduction in pain at all". The patient is instructed to mark a point on the line that will accurately reflect his or her own pain. The distance of the patient's sign to the left end is measured. This distance, usually measured in millimeters, is reported as "points".
次要结局
- State and Trait Anxiety Scale(five month)
研究者
Simge Ozturk
Principal Investigator
Inonu University