Breast CancerNCT06767059
The Effect of Walking and Grounding in Women With Breast Cancer
A study testing Walking Group and Grounding Group in people with Breast Cancer, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Walking Group and Grounding Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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,
Who cannot join
- 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 neurological or psychiatric illness,
- Communication problems,
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- Bone metastases,
- Bilateral mastectomies,
- Criteria for Withdrawal from the Study:
- Withdrawal from the study at any stage,
- Hospitalization,
- Failure to follow the guidelines or perform the intervention-walking for 30 minutes at least three times a week or walking plus grounding-in the intervention group,
- Starting a regular exercise program during the study period in the control group.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Health Research and Application Center Gazi Hospital
Ankara
About this study
Official title: The Effect of Walking and Grounding on Pain Intensity, Fatigue Level, and Sleep Quality in Women With Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Walking Group, Grounding Group
- Keywords
- Breast cancer, Walking, Grounding, Nursing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking GroupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Walking Group | Experimental | Patients will walk for 30 minutes at least 3 times a week. Receives: Other: Walking Group |
| Grounding Group | Experimental | Patients will walk with a grounding stick for 30 minutes at least 3 times a week. Receives: Other: Grounding Group |
| Control Group | No intervention | Routine follow-up will be done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
It will be used in the study to measure pain severity. The VAS consists of a measured horizontal or vertical line with definitions such as "no symptoms" or "severe symptoms" at both ends. The severity of the patient's symptoms is measured by marking a numbered point on this line. For pain symptoms, the severity is marked on a 10 cm (100 mm) ruler with "no pain" at one end and "unbearable pain" at the other. The intervals for pain severity are defined as follows: <3 mild pain, 3-6 moderate pain, >6 severe pain. The VAS is a reliable and valid method for assessing pain intensity (Arslan et al., 2016).
It is measured as 0 none, 1-3 mild, 4-6 moderate, and 7-9 severe.
Measured: 0,4,8 weeks
Secondary outcomes (2)
Visual Similarity Scale for Fatigue
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.
Measured: 0,4,8 weeks
Pittssburgh Sleep Quality Index
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
Measured: 0,4,8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start30 Jan 2025
- Primary completion18 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups with walking, grounding and control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baise Bicav, Ankara University
- Investigators
- Baise Bicav, MSc, Principal investigator, Ankara UniversitySevinç Kutlutürkan, PhD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767059
- Sponsor's protocol ID
- AÜ-HEM-BB-01
- Status last verified
- May 2026
- First submitted
- 5 Jan 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Walking and Grounding on Pain Intensity, Fatigue Level, and Sleep Quality in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT06767059
- Acronym / sponsor ID
- AÜ-HEM-BB-01
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Walking, Grounding, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 18 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups with walking, grounding and control group
| Arm | Type | Receives |
|---|---|---|
| Walking Group | Experimental | Other: Walking GroupPatients will walk for 30 minutes at least 3 times a week. |
| Grounding Group | Experimental | Other: Grounding GroupPatients will walk with a grounding stick for 30 minutes at least 3 times a week. |
| Control Group | No intervention | –Routine follow-up will be done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (13 listed)
- 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 neurological or psychiatric illness,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking GroupPatients 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. | Other | Walking Group |
| Grounding GroupPatients 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. | Other | Grounding Group |
Primary outcome
Visual Analog Scale
Time frame: 0,4,8 weeks
It will be used in the study to measure pain severity. The VAS consists of a measured horizontal or vertical line with definitions such as "no symptoms" or "severe symptoms" at both ends. The severity of the patient's symptoms is measured by marking a numbered point on this line. For pain symptoms, the severity is marked on a 10 cm (100 mm) ruler with "no pain" at one end and "unbearable pain" at the other. The intervals for pain severity are defined as follows: <3 mild pain, 3-6 moderate pain, >6 severe pain. The VAS is a reliable and valid method for assessing pain intensity (Arslan et al., 2016). It is measured as 0 none, 1-3 mild, 4-6 moderate, and 7-9 severe.
2 secondary outcomes
Visual Similarity Scale for Fatigue
Time frame: 0,4,8 weeks
Pittssburgh Sleep Quality Index
Time frame: 0,4,8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baise Bicav, MSc principal investigator
Ankara University
Sevinç Kutlutürkan, PhD principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking Group and Grounding Group in people with Breast Cancer, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 0,4,8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.