The Effect of Grounding During Pregnancy

Not Applicable

Recruiting

• Conditions: Pregnancy Related; Cramp, Limb
• Interventions: Other: Grounding; Other: Sham grounding

• Registration Number: NCT05557188
• Lead Sponsor: Ege University

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 Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-27
• Study Start: 2022-11-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-05-01
• Primary Completion: 2023-11-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grounding	Grounding	Each pregnant woman in the placebo group is going to be informed about the grounding stick and how to use it, with a 2-minute video showing. Participants walk on the ground for 30 minutes daily and go on for four weeks. During the program, the pregnant women will be called to their homes every week and necessary reminders will be made.
Sham Grounding	Sham grounding	Each pregnant woman in the placebo group is going to be informed about the Sham grounding stick and how to use it, with a 2-minute video showing. Participants walk on the ground for 30 minutes daily and go on for four weeks. During the program, the pregnant women will be called to their homes every week and necessary reminders will be made.

Primary Outcome Measures

Name	Time	Method
Leg Cramps Evaluation Form	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	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 Outcome Measures

Name	Time	Method
Visual analog scale for Fatigue	12 minutes	The scale consists of two categories: fatigue (items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18) and energy (items 6, 7, 8, 9, 10). It consists of sub-dimensions and 18 items. There are 10 cm long horizontal lines with positive words on one end of the scale and negative words on the other.
Short Form-12 Quality of Life Scale	12 minutes.	It consists of 12 questions selected from the SF-36 Health Questionnaire. SF-12 consists of physical functionality, physical role, pain, general health, emotional role, social functionality and vitality subcomponents.
Pregnancy-Related Anxiety Scale	8 minutes.	The 11-item questionnaire was structured in three dimensions: fear of giving birth (items 1, 2, 6 and 8), concerns about carrying a disabled child (items 4, 9, 10 and 11) and concerns about your own appearance (3, 5 and 7). ) contains. The eighth item of the questionnaire ("I am worried about childbirth because I have never experienced it before") applies only to primiparous women. Items are rated from 1-5 (1 = "not at all relevant" and 5 = "very relevant"). Higher scores mean a worse outcome.

Trial Locations

Locations (2)

Ege University; 🇹🇷 İzmir, Turkey

Murat Pehlivan; 🇹🇷 İzmir, Turkey