Cramp, LimbNCT05557188
The Effect of Grounding During Pregnancy
A study testing Grounding in people with Cramp, Limb and Pregnancy Related, run by Ege University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cramp, Limb, Pregnancy Related
- What is being tested?
- Grounding
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Nazan TUNA ORAN contact
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ege University
Izmir
Nazan Oran, Ph.D.
- Not yet recruiting
Murat Pehlivan
Izmir
Nazan TUNA ORAN, +905369364763, nazanoran@gmail.com
About this study
Official title: The Effect of Grounding on Leg Cramps, Sleep, Fatigue, Anxiety, and Quality of Life During Pregnancy
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.
Read the 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.
- Conditions
- Cramp, Limb, Pregnancy Related
- Being tested
- Grounding, Sham grounding
- Keywords
- Cramp, Fatigue, Pregnancy
- Medical subject headings
- Muscle Cramp, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GroundingOther
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 groundingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sham grounding |
| 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. Receives: Other: Grounding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 minutes.
Secondary outcomes (3)
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.
Measured: 12 minutes
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.
Measured: 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.
Measured: 12 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Nov 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cramp, LimbStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esma Yuksel, Ege University
- Investigators
- Esma YUKSEL, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557188
- Sponsor's protocol ID
- 20-4T/39
- Status last verified
- Apr 2023
- First submitted
- 19 Sep 2022
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allen RE, Kirby KA. Nocturnal leg cramps. Am Fam Physician. 2012 Aug 15;86(4):350-5.
PubMed 22963024Chevalier 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.
PubMed 22757749Brown 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.
PubMed 20192911
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Grounding on Leg Cramps, Sleep, Fatigue, Anxiety, and Quality of Life During Pregnancy
- ClinicalTrials.gov ID
- NCT05557188
- Acronym / sponsor ID
- 20-4T/39
- Conditions
- Cramp, Limb, Pregnancy Related
- Keywords
- Cramp, Fatigue, Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Grounding | Placebo comparator | Other: Sham groundingEach 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. |
| Grounding | Active comparator | Other: GroundingEach 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GroundingEach 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. | Other | Grounding |
| Sham groundingEach 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. | Other | Sham Grounding |
Primary 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.
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.
3 secondary outcomes
Visual analog scale for Fatigue
Time frame: 12 minutes
Pregnancy-Related Anxiety Scale
Time frame: 8 minutes.
Short Form-12 Quality of Life Scale
Time frame: 12 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Results publication: PubMed 22963024Allen RE, Kirby KA. Nocturnal leg cramps. Am Fam Physician. 2012 Aug 15;86(4):350-5.
- Results publication: PubMed 22757749Chevalier 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.
- Results publication: PubMed 20192911Brown 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.
- Individual participant dataSharing planned: No
Related trials for Cramp, Limb
Active, not recruiting
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Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazan TUNA ORAN contact
Esma YUKSEL principal investigator
Ege University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grounding in people with Cramp, Limb and Pregnancy Related, run by Ege University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esma YUKSEL (+905522456135, esmdgn06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: 10 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05557188, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.