Clinical trial NCT06767059: The Effect of Walking and Grounding in Women With Breast Cancer
Official title: The Effect of Walking and Grounding on Pain Intensity, Fatigue Level, and Sleep Quality in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Walking
Grounding
Nursing
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups with walking, grounding and control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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,

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 0,4,8 weeks
Secondary outcomes:
measure: Visual Similarity Scale for Fatigue
timeFrame: 0,4,8 weeks
measure: Pittssburgh Sleep Quality Index
timeFrame: 0,4,8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Health Research and Application Center Gazi Hospital
Study officials:
affiliation: Ankara University
name: Baise Bicav, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University
name: Sevinç Kutlutürkan, PhD
role: PRINCIPAL_INVESTIGATOR
References: