Clinical trial NCT05557188: The Effect of Grounding During Pregnancy
Official title: The Effect of Grounding on Leg Cramps, Sleep, Fatigue, Anxiety, and Quality of Life During Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cramp, Limb
Pregnancy Related
Keywords: Cramp, Fatigue, Pregnancy
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 10 minutes.
measure: Leg Cramps Evaluation Form
timeFrame: 3 minutes.
Secondary outcomes:
measure: Visual analog scale for Fatigue
timeFrame: 12 minutes
measure: Pregnancy-Related Anxiety Scale
timeFrame: 8 minutes.
measure: Short Form-12 Quality of Life Scale
timeFrame: 12 minutes.
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
city: İzmir
country: Turkey
facility: Murat Pehlivan
Study officials:
affiliation: Ege University
name: Esma YUKSEL
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen RE, Kirby KA. Nocturnal leg cramps. Am Fam Physician. 2012 Aug 15;86(4):350-5.
citation: Chevalier G, Sinatra ST, Oschman JL, Delany RM. Earthing (grounding) the human body reduces blood viscosity-a major factor in cardiovascular disease. J Altern Complement Med. 2013 Feb;19(2):102-10. doi: 10.1089/acm.2011.0820. Epub 2012 Jul 3.
citation: Brown D, Chevalier G, Hill M. Pilot study on the effect of grounding on delayed-onset muscle soreness. J Altern Complement Med. 2010 Mar;16(3):265-73. doi: 10.1089/acm.2009.0399.