The Effect of Grounding During Pregnancy

NCT05557188 | Unknown DMC

• 1 other identifier: 20-4T/39
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

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.

Conditions

Cramp, Limb; Pregnancy Related

Keywords

Cramp, Fatigue, Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (3)

• Visual analog scale for Fatigue

  12 minutes

• Pregnancy-Related Anxiety Scale

  8 minutes.

• Short Form-12 Quality of Life Scale

  12 minutes.

Study Arms (2)

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.

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.

Other: Grounding

Interventions

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.

Grounding

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.

Sham Grounding

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: In this study, pregnant women are going to enroll.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (2)

Ege University

Izmir, Turkey (Türkiye)

RECRUITING

Murat Pehlivan

Izmir, Turkey (Türkiye)

NOT YET RECRUITING

Related Publications (3)

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

  PMID: 22963024 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.

  PMID: 22757749 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.

  PMID: 20192911 RESULT

MeSH Terms

Conditions

Muscle Cramp; Fatigue

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esma YUKSEL

  Ege University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esma YUKSEL

CONTACT

+905522456135; esmdgn06@gmail.com

Nazan TUNA ORAN

CONTACT

+905369364763

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant at the Faculty of Health Sciences, Ege University. Midwife, MSc., PhD. (Candidate)

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 27, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)