The Effect of Walking and Grounding in Women With Breast Cancer

NCT ID: NCT06767059

Last Updated: 2025-08-14

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

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-30

Study Completion Date

2026-03-15

Brief Summary

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This randomized controlled trial was conducted to examine the effect of walking and grounding on pain intensity, fatigue level and sleep quality in women diagnosed with breast cancer.

Detailed Description

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Grounding is the flow of electrons by direct contact of the body's natural electric charge with the earth. There are many methods of grounding. Earthing systems can be used while sitting or sleeping, or the cheapest and easiest way is to walk barefoot in a grassy park, garden or beach. Earthing improves circulation by increasing blood flow and oxygenation of each organ system, positively affecting cardiovascular function. Hormones normalize, cortisol drops, blood sugar stabilizes, sleep improves, energy increases and inflammation decreases. When electrical contact between the body and the earth is re-established through grounding, organ system function begins to optimize again. When people are grounded, they feel more alive, healthy and energized than when they are ungrounded. The literature reports that human grounding has many positive effects on pain, sleep and fatigue. Grounding can be an effective method in managing pain, fatigue and sleep problems, which are among the most common problems in patients with breast cancer. Earthing is one of the biggest challenges of the modern world. City life, contact with the land The decline of the earth's energy supply, living and working indoors, and wearing plastic shoes disrupt our natural energy circuit. Although barefoot walking is the cheapest and easiest way to become grounded, dirty soil, foot This method may be a disadvantage for women with breast cancer due to conditions such as wounding of the base. In this study, a conductive device is used for grounding cancer patients by providing indirect contact with the soil.

grounding will be ensured while walking with the stick. While grounding has many positive effects on health, no grounding study was found in the literature review in the field of nursing. This study is a part of both the It is thought to positively affect the pain, fatigue and sleep problems of women with breast cancer by walking with shoes and providing grounding in order to use the positive effects of grounding.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups with walking, grounding and control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants will not be told which group they are in the study. To prevent selection bias in the study, the determination of the groups will be made by the nurse outside the study. To prevent omission and reporting bias in the study, the data will be coded with the letters A, B and C without specifying which group they are in. The data will be computerized by a person outside the study. Data will be analyzed coded in terms of groups.

Study Groups

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Walking Group

Patients will walk for 30 minutes at least 3 times a week.

Group Type EXPERIMENTAL

Walking Group

Intervention Type OTHER

Patients will be asked to walk for 30 minutes at least 3 times for 8 weeks. In order to ensure regular follow-up, patients will be asked to write on the walking tracking form when they walk and the number of steps before they start walking and the number of steps after walking using the application.

Grounding Group

Patients will walk with a grounding stick for 30 minutes at least 3 times a week.

Group Type EXPERIMENTAL

Grounding Group

Intervention Type OTHER

Patients will be asked to walk with a grounding stick for 30 minutes at least 3 times for 8 weeks. Patients will be asked to fill in the walking follow-up form and grounding follow-up form for regular follow-up.

Control Group

Routine follow-up will be done.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Walking Group

Patients will be asked to walk for 30 minutes at least 3 times for 8 weeks. In order to ensure regular follow-up, patients will be asked to write on the walking tracking form when they walk and the number of steps before they start walking and the number of steps after walking using the application.

Intervention Type OTHER

Grounding Group

Patients will be asked to walk with a grounding stick for 30 minutes at least 3 times for 8 weeks. Patients will be asked to fill in the walking follow-up form and grounding follow-up form for regular follow-up.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older,
* Can read and write and speak Turkish,
* Diagnosed with primary breast cancer and know the diagnosis,
* Volunteered to participate in the research,
* Living in Ankara province,
* Paclitaxel or Paclitaxel-Transtuzumab based chemotherapy treatment initiated,
* Eastern Cooperative Oncology Group (ECOG) Scale 0 or 1,
* NCI-CTCAE v5.0 Pain, fatigue and sleep toxicity grade 1 or 2,
* You have a phone with an iOS or Android processor,

Exclusion Criteria

* Open wounds or edema of the hands and feet,
* NCI-CTCAE v5.0 motor and sensory peripheral neuropathy with toxicity grade 3,4 or 5,
* People with a disability that would prevent them from walking,
* Diagnosed cardiovascular and pulmonary disorders,
* Diagnosed psychiatric illness,
* Communication problems,
* Bone metastases,
* Bilateral mastectomies,
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Baise Bicav

Science Specialist Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baise Bicav, MSc

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Sevinç Kutlutürkan, PhD

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

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Gazi University Health Research and Application Center Gazi Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Baise Bicav

Role: CONTACT

05454702157

Sevinç Kutlutürkan

Role: CONTACT

03122126040

Other Identifiers

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AÜ-HEM-BB-01

Identifier Type: -

Identifier Source: org_study_id

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