The Effect of Grounding During Pregnancy

NCT ID: NCT05557188

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-02-01

Brief Summary

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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.

Detailed Description

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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

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Cramp, Limb Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Sham grounding

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Grounding

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Esma Yuksel

Research assistant at the Faculty of Health Sciences, Ege University. Midwife, MSc., PhD. (Candidate)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esma YUKSEL

Role: PRINCIPAL_INVESTIGATOR

Ege University

Locations

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Ege University

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Murat Pehlivan

Izmir, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Esma YUKSEL

Role: CONTACT

+905522456135

Nazan TUNA ORAN

Role: CONTACT

+905369364763

Facility Contacts

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Nazan Oran, Ph.D.

Role: primary

Nazan TUNA ORAN

Role: primary

+905369364763

References

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Allen RE, Kirby KA. Nocturnal leg cramps. Am Fam Physician. 2012 Aug 15;86(4):350-5.

Reference Type RESULT
PMID: 22963024 (View on PubMed)

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.

Reference Type RESULT
PMID: 22757749 (View on PubMed)

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.

Reference Type RESULT
PMID: 20192911 (View on PubMed)

Other Identifiers

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20-4T/39

Identifier Type: -

Identifier Source: org_study_id

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