Peripheral Arterial DiseaseNCT06001203
Foot Reflexology and Pain and Ankle Brachial Index and Walking Impairement
A study testing Reflexology in people with Peripheral Arterial Disease, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aimed to determine the effect of foot reflexology on pain, walking impairement and ankle brachial index level in patients with peripheral artery disease Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Reflexology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 30 Jan 2024
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients over 18 years of age with PAH;
- no fractures or open wounds in both lower extremities;
- absence of unilateral or bilateral amputation of the lower extremities
Who cannot join
- having an acute infection with fever;
- requiring an acute surgical condition
- undergoing femoral-popliteal bypass surgery
- Having a verbal communication problem such as Alzheimer's or dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Foot Reflexology on Pain, Walking Impairement and Ankle Brachial Index Level in Patients With Peripheral Artery Disease
This randomized controlled study aimed to determine the effect of foot reflexology on pain, walking impairement and ankle brachial index level in patients with peripheral artery disease
Read the detailed description
Patients with PAH may experience pain in the legs, cramps, pain or aching symptoms (claudication) in the hip, thigh or leg calf, along with compulsive movements such as walking. Reflexology is reported to have effects such as protecting the tissue integrity of the feet, increasing skin turgor, reducing neuropathic pain and increasing peripheral blood flow. For this reason, this study aimed to determine the effect of foot reflexology on pain, walking impairement and ankle brachial index level in patients with peripheral artery disease.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Reflexology
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyProcedure or surgery
Reflexology is a method that creates nervous, hormonal and energetic effects in the body using pressure, rubbing and stretching applied with special hand and finger techniques to reflex points corresponding to all parts, organs and systems of the body in the ears, hands and feet
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The intervention group is received two reflexology sessions. Receives: Procedure: Reflexology |
| control group | No intervention | The control group is given routine care and no intervention will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)
Measured: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session
Walking Impairment Questionnaire
The "Walking Impairment Questionnaire" is a self-report tool that evaluates walking distance and capacity. While the first 7 questions of the tool constitute the part where claudication and differential diagnosis are evaluated individually, the following 14 items are evaluated from 0 (can't do, very difficult) to 4 (no difficulty) on the Likert scale. The scale's walking distance, walking speed and stair climbing subscales are evaluated by evaluating the weights of each question, and total and subscale scores are calculated and evaluated between 0 and 100 points. A low score indicates poor walking performance.
Measured: Baseline, after 2 days second reflexology sessions
Ankle Brachial Index
Ankle-brachial index is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery.
Measured: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session
Secondary outcomes (2)
Toe oxygen saturation level
Toe oxygen saturation level is measured pulse oximetry. This method used to examine oxygen saturation in various parts of body.
Measured: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session
Rate of Participants Edema level
Rate of Participants Edema level is measured from the ankle and calf with a tape measure.
Measured: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start15 Jul 2023
- Primary completion29 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif BUDAK ERTÜRK, Baskent University
- Investigators
- Elif BUDAK ERTÜRK, PhD, RN, Principal investigator, Baskent University Faculty of Health Science Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001203
- Sponsor's protocol ID
- KA23-152
- Status last verified
- May 2025
- First submitted
- 3 Aug 2023
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Reflexology on Pain, Walking Impairement and Ankle Brachial Index Level in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT06001203
- Acronym / sponsor ID
- KA23-152
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 21 Aug 2023 (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 study aimed to determine the effect of foot reflexology on pain, walking impairement and ankle brachial index level in patients with peripheral artery disease
Detailed description
Patients with PAH may experience pain in the legs, cramps, pain or aching symptoms (claudication) in the hip, thigh or leg calf, along with compulsive movements such as walking. Reflexology is reported to have effects such as protecting the tissue integrity of the feet, increasing skin turgor, reducing neuropathic pain and increasing peripheral blood flow. For this reason, this study aimed to determine the effect of foot reflexology on pain, walking impairement and ankle brachial index level in patients with peripheral artery disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: ReflexologyThe intervention group is received two reflexology sessions. |
| control group | No intervention | –The control group is given routine care and no intervention will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients over 18 years of age with PAH;
- no fractures or open wounds in both lower extremities;
- absence of unilateral or bilateral amputation of the lower extremities
Key exclusion criteria (4 listed)
- having an acute infection with fever;
- requiring an acute surgical condition
- undergoing femoral-popliteal bypass surgery
- Having a verbal communication problem such as Alzheimer's or dementia
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 |
|---|---|---|
| ReflexologyReflexology is a method that creates nervous, hormonal and energetic effects in the body using pressure, rubbing and stretching applied with special hand and finger techniques to reflex points corresponding to all parts, organs and systems of the body in the ears, hands and feet | Procedure or surgery | intervention group |
Primary outcome
Numeric Pain Rating Scale
Time frame: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session
Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)
Walking Impairment Questionnaire
Time frame: Baseline, after 2 days second reflexology sessions
The "Walking Impairment Questionnaire" is a self-report tool that evaluates walking distance and capacity. While the first 7 questions of the tool constitute the part where claudication and differential diagnosis are evaluated individually, the following 14 items are evaluated from 0 (can't do, very difficult) to 4 (no difficulty) on the Likert scale. The scale's walking distance, walking speed and stair climbing subscales are evaluated by evaluating the weights of each question, and total and subscale scores are calculated and evaluated between 0 and 100 points. A low score indicates poor walking performance.
Ankle Brachial Index
Time frame: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session
Ankle-brachial index is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery.
2 secondary outcomes
Toe oxygen saturation level
Time frame: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session
Rate of Participants Edema level
Time frame: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session
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 31 May 2025.
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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.
Elif BUDAK ERTÜRK, PhD, RN principal investigator
Baskent University Faculty of Health Science Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology in people with Peripheral Arterial Disease, run by Baskent 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 3 inclusion and 4 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 31 May 2025. 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?
Numeric Pain Rating Scale (time frame: Two reflexology sessions will be applied within one week and 4 measurements will be made. •Baseline (before first reflexology session), •After first reflexology session, •Before second reflexology session, •After second reflexology session). The study lists 3 primary outcomes in all. 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 31 May 2025.