The Effect of Grounding on Leg Cramps, Sleep, Fatigue, Anxiety, and Quality of Life During Pregnancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ege University
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Leg Cramps Evaluation Form
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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,
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Leg Cramps Evaluation Form
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Visual analog scale for Fatigue(12 minutes)
- Short Form-12 Quality of Life Scale(12 minutes.)
- Pregnancy-Related Anxiety Scale(8 minutes.)
Investigators
Esma Yuksel
Research assistant at the Faculty of Health Sciences, Ege University. Midwife, MSc., PhD. (Candidate)
Ege University