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The Effect of Grounding During Pregnancy

Primary Purpose

Cramp, Limb, Pregnancy Related

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Grounding
Sham grounding
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cramp, Limb focused on measuring Cramp, Fatigue, Pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ege UniversityRecruiting
  • Murat Pehlivan

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sham Grounding

Grounding

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 19, 2022
Last Updated
April 27, 2023
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT05557188
Brief Title
The Effect of Grounding During Pregnancy
Official Title
The Effect of Grounding on Leg Cramps, Sleep, Fatigue, Anxiety, and Quality of Life During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cramp, Limb, Pregnancy Related
Keywords
Cramp, Fatigue, Pregnancy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham Grounding
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Grounding
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Grounding
Intervention Description
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
Intervention Name(s)
Sham grounding
Intervention Description
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 Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
10 minutes.
Title
Leg Cramps Evaluation Form
Description
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.
Time Frame
3 minutes.
Secondary Outcome Measure Information:
Title
Visual analog scale for Fatigue
Description
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.
Time Frame
12 minutes
Title
Pregnancy-Related Anxiety Scale
Description
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.
Time Frame
8 minutes.
Title
Short Form-12 Quality of Life Scale
Description
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.
Time Frame
12 minutes.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
In this study, pregnant women are going to enroll.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esma YUKSEL
Phone
+905522456135
Email
esmdgn06@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nazan TUNA ORAN
Phone
+905369364763
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esma YUKSEL
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University
City
İzmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nazan Oran, Ph.D.
Facility Name
Murat Pehlivan
City
İzmir
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nazan TUNA ORAN
Phone
+905369364763
Email
nazanoran@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22963024
Citation
Allen RE, Kirby KA. Nocturnal leg cramps. Am Fam Physician. 2012 Aug 15;86(4):350-5.
Results Reference
result
PubMed Identifier
22757749
Citation
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.
Results Reference
result
PubMed Identifier
20192911
Citation
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.
Results Reference
result

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The Effect of Grounding During Pregnancy

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