The Effect of Acupressure on Pain, Menstrual Symptoms, and General Comfort in Adolescents with Primary Dysmenorrhea: a Single-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
In this study, it is planned to determine the effect of acupressure applied to adolescents with primary dysmenorrhea on pain, menstrual symptoms and general comfort. The research questions of the research are as follows; Research Questions
- Is there a difference in pain scores in the post-acupressure intervention group and the placebo group?
- Is there a difference between menstrual symptoms scores in the post-acupressure intervention group and the placebo group?
- Is there a difference between comfort scores in the intervention group and the placebo group after acupressure?
- Is there a difference between the pain scores of the intervention group according to time?
- Is there a difference between the menstrual symptoms scores of the intervention group according to time?
- Is there a difference between the comfort scores of the intervention group according to time? Is there a difference between the pain scores of the placebo group over time? Is there a difference between the menstrual symptoms scores of the placebo group over time?
- Is there a difference between the comfort scores of the placebo group over time?
详细描述
Methods:
Adolescents aged 14-17 years with primary dysmenorrhea will be randomly assigned to the acupressure and control groups. The study group (n=26) and placebo group (n=26) will be applied to the determined points in a certain order. The order of application is Hegu (LI4), Zusanli (ST36), Sanyinjiao (SP6). Acupressure will be applied to the adolescents in the groups individually for 18-20 minutes, twice a day in the first three days of their menstrual periods. The primary outcome measures of the study is the effect of acupressure on adolescent pain severity and menstrual symptoms. The secondary outcome measures of the study is the effect of acupressure on general comfort. Data collection forms will be applied four times in total for the second and third cycles, before and immediately after the acupressure application.
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
Adolescents who agreed to participate in the study by signing the voluntary consent form after being informed about the study will be assigned to the study or placebo groups by matching the numbers on the envelope according to their school numbers. In the study, a researcher will determine the acupressure and placebo points to be applied in adolescents and this researcher will make the first cycle application. Therefore, the researcher cannot be blinded. However, the participants will practice and be blinded without knowing whether the points to be treated are the acupressure point or the placebo point. Thus, the research will be carried out as a single-blind randomized controlled trial. When the research is completed, the data of the control and study groups (coded as A or B) will be transferred to the computer environment by a researcher independent of the research, and the data will be analyzed by a statistician and the findings will be reported.
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Those between the ages of 14-17,
- •Willing to participate in the research,
- •Open to communication,
- •Having a regular menstrual period (occurring at intervals of 21-35 days and lasting 3-8 days),
- •Menstrual pain severity is at least 4 according to the Visual Pain Scale,
- •A score of 60 or more on the Menstruation Symptom Scale,
- •Not using hormonal contraception and intrauterine device,
- •Not pregnant and not experiencing pregnancy before,
- •Does not have a systemic and chronic disease,
- •Have not had a gynecological disorder or surgery before,
- •Not using analgesics 6 hours before and during the study period,
- •Body mass index <30 kg/m2
- •No physical/mental health problems that would prevent/limit acupressure and exercise,
- •Not doing regular acupressure,
- •No psychiatric problems
- •Adolescents without active COVID-19 infection.
排除标准
- •Not between the ages of 14-17,
- •Not willing to participate in the research,
- •Closed to communication,
- •Not having a regular menstrual period (not occurring at intervals of 21-35 days and lasting more or less than 3-8 days),
- •Menstrual pain severity is less than 4 according to the Visual Pain Scale,
- •A score below 60 on the Menstruation Symptom Scale,
- •Using hormonal contraception and intrauterine device,
- •Pregnant and experienced pregnancy before,
- •Having a systemic and chronic disease,
- •Have had a previous gynecological disorder or surgery,
- •Using analgesics 6 hours before and during the study period,
- •Body mass index ≥30 kg/m2
- •Having physical/mental health problems that will prevent/limit acupressure and exercise,
- •Regular acupressure
- •Having a psychiatric problem
- •Adolescents with active COVID-19 infection.
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).
Pain will be evaluated by using the "Visual Analog Skala (VAS)" . The Visual Analog Scale is used to measure the pain perceived by the person. There is a 10 cm mark on the one end of the scale, where there is no pain (zero), and on the other end there is the most severe (10) pain. Between the (100 mm.) part, the individual can indicate his or her pain by drawing a line, putting a dot or pointing. The distance from the point where there is no pain to the point marked by the individual is measured in centimeters, and the value found indicates the severity of the individual's pain. In the VAS scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, while 75-100 mm indicates severe pain.
Menstrual Symptom Questionnaire (MSQ)
时间窗: change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).
Menstrual symptoms will be evaluated by using the "Menstrual Symptom Questionnaire ". The Menstrual Symptom Questionnaire was developed by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. The scale, which is a five-point Likert type and consists of 24 items, was updated by Negriff et al. in 2009 by re-evaluating its factor structure and usability. The MSQ score is calculated by taking the total mean score of the items in the scale. An increase in the mean score indicates an increase in the severity of menstrual symptoms. The original Cronbach's Alpha value of the scale was .86 and had three sub-dimensions: "Negative Effects/Somatic Complaints", "Menstrual Pain" and "Abdominal Pain". The Turkish validity and reliability study of the Menstruation Symptom Questionnaire was performed by Güvenç et al. in 2014. Two items (6th and 17th items) in the original of the scale were removed from the scale because they had an item-total score correlation of less than 0.30. The scale
次要结局
- General Comfort Scale (GAS)(change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).)
研究者
Ahu AKSOY
Research Assistant, PhD
Mersin University