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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Grounding | Placebo Comparator | 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. |
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| Grounding | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grounding | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index | 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. | 10 minutes. |
| Leg Cramps Evaluation Form | 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. | 3 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale for Fatigue | 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. | 12 minutes |
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Inclusion Criteria:
Exclusion Criteria:
In this study, pregnant women are going to enroll.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esma YUKSEL | Contact | +905522456135 | esmdgn06@gmail.com | |
| Nazan TUNA ORAN | Contact | +905369364763 |
| Name | Affiliation | Role |
|---|---|---|
| Esma YUKSEL | Ege University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University | Recruiting | Izmir | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22963024 | Result | Allen RE, Kirby KA. Nocturnal leg cramps. Am Fam Physician. 2012 Aug 15;86(4):350-5. | |
| 22757749 | Result | 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. |
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| ID | Term |
|---|---|
| D009120 | Muscle Cramp |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| Sham grounding | Other | 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. |
|
| Pregnancy-Related Anxiety Scale |
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. |
| 8 minutes. |
| Short Form-12 Quality of Life Scale | 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. | 12 minutes. |
| Murat Pehlivan | Not yet recruiting | Izmir | Turkey (Türkiye) |
|
| 20192911 | Result | 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. |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |