The Effect of Grounding on Leg Cramps, Sleep, Fatigue, Anxiety, and Quality of Life During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Leg Cramps Evaluation Form
研究概览
简要总结
The study was planned as a randomized controlled trial. The research data included a pregnant informed form, leg cramps evaluation form, Pittsburgh Sleep Quality Index, Visual Analog Scale for fatigue, Pregnancy-Related Anxiety Scale, Short Form-12 Quality of Life Scale, food consumption record form, and pregnancy follow-up form will be used. Questionnaires will be evaluated every two weeks, and the intervention will continue for four weeks in total for each pregnant woman.
详细描述
The aim of the research is to investigate the effect of grounding on muscle cramps, sleep quality, fatigue, anxiety, and quality of life in pregnant women. The study was planned as a randomized controlled trial. The study is going to perform in the Obstetrics and Gynecology Clinic of Ege University Medical Faculty Hospital. The research will be carried out by face-to-face interview method. The research data included a pregnant informed form, leg cramps evaluation form, Pittsburgh Sleep Quality Index, Visual Analog Scale for fatigue, Pregnancy-Related Anxiety Scale, Short Form-12 Quality of Life Scale, food consumption record form, and pregnancy follow-up form will be used. The pregnant women included in the study will be divided into two groups as intervention and placebo groups by randomization and will be asked to take a walk for 30 minutes every day with a grounding/sham grounding pole. Questionnaires will be evaluated every two weeks, and the intervention will continue for four weeks in total for each pregnant woman.
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)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 27-34 weeks of pregnancy,
- •Having leg cramps,
- •Normal blood levels of calcium and magnesium in her current pregnancy,
- •No risky pregnancy, or chronic disease (heart disease, hypertension, thyroid diseases, diabetes mellitus, kidney disease, etc.)
- •Not having multiple pregnancies,
排除标准
- •Risky pregnancy, chronic disease (heart disease, hypertension, thyroid diseases, diabetes mellitus, kidney disease, etc.),
- •Emerging Rheumatic Disease,
- •Varicose veins in the legs,
- •Diagnosed with restless legs syndrome,
- •Pregnant women with blood levels of Calcium and Magnesium below the normal level will be excluded from the study.
结局指标
主要结局
Leg Cramps Evaluation Form
时间窗: 3 minutes.
There are questions about the duration and frequency of leg cramps, what has been done to relieve the pain and the Visual Analog Scale that will be used to assess the pain in leg cramps. Higher scores mean worse outcome.
Pittsburgh Sleep Quality Index
时间窗: 10 minutes.
It is a safe and consistent sleep questionnaire that includes 24 questions to evaluate sleep quality, amount of sleep, presence and severity of sleep disorder in the last month.
次要结局
- Visual analog scale for Fatigue(12 minutes)
- Short Form-12 Quality of Life Scale(12 minutes.)
- Pregnancy-Related Anxiety Scale(8 minutes.)
研究者
Esma Yuksel
Research assistant at the Faculty of Health Sciences, Ege University. Midwife, MSc., PhD. (Candidate)
Ege University