The Effect of Walking and Grounding in Women With Breast Cancer

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06767059
• Lead Sponsor: Ankara University

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-05
• Study First Submitted QC: 2025-01-05
• Study First Posted: 2025-01-09
• Study Start: 2025-01-30
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-08-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 54

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	0,4,8 weeks	The VAS usually consists of a measured horizontal or vertical line with definitions such as "no symptom or severe symptom" on both ends. The measurement is achieved by the patient marking a numbered point on this line to indicate the severity of the symptom experienced. Pain intensity is marked on a 10 cm ruler with no pain at one end and unbearable pain at the other end. The ranges for pain intensity are stated as \<3 mild pain, 3-6 moderate pain, \>6 severe pain. The VAS is a reliable and valid pain measurement method for the assessment of pain intensity. 0 is marked as none to 10 as very much. 0 is measured as none, 1-3 as mild, 4-6 as moderate and 7-9 as severe.

Secondary Outcome Measures

Name	Time	Method
Visual Similarity Scale for Fatigue	0,4,8 weeks	The scale consists of 18 items and two subscales: fatigue (items 1-5, 11-18) and energy (items 6-10). There are 10 cm long horizontal lines with positive and negative statements at one end and negative statements at the other end of the FLSS, respectively. While the items of the fatigue subscale progress from positive to negative, the energy subscale has the opposite order. The lowest score obtained from the fatigue subscale is 0 and the highest score is 130. In the energy subscale, the scores are in the range of 0 to 50. A high score on the fatigue subscale and a low score on the energy subscale indicates that the severity of fatigue is high. In the validity and reliability study of the scale, it was reported that the Cronbach's α internal consistency coefficient for the 13-item fatigue subscale was 0.90 and 0.74 for the 5-item energy subscale.
Pittssburgh Sleep Quality Index	0,4,8 weeks	The Pittsburgh sleep quality index is a reliable and consistent sleep questionnaire that includes 24 questions to assess sleep quality, amount of sleep, presence and severity of sleep disturbance in the last one month. Its diagnostic sensitivity is 89.6% and specificity is 86.5%. The PSQI consists of seven components assessing subjective sleep quality, sleep latency, sleep duration, sleep efficiency-established sleep efficiency, sleep disturbance, sleep medication use, and impairment in daytime activities. Some of these components consist of a single question, while others are a grouping of several questions. Scoring consists of the scores given to the questions or groups of questions covered by these components. The sum of the scores of the seven components gives the total PDQI score. Each question is evaluated on a 0-3 point scale. The total score has a value between 0-21. A high total score indicates poor sleep quality

Trial Locations

Locations (1)

Gazi University Health Research and Application Center Gazi Hospital; 🇹🇷 Ankara, Turkey