Foot Reflexology and Pain and Ankle Brachial Index

Study Overview
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Brief Summary
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This randomized controlled study aimed to determine the effect of foot reflexology on pain and ankle brachial index level in patients with peripheral artery disease

Detailed Description
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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 and ankle brachial index level in patients with peripheral artery disease.

Official Title
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The Effect of Foot Reflexology on Pain and Ankle Brachial Index Level in Patients With Peripheral Artery Disease

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Reflexology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>The intervention group is received two reflexology sessions. | Procedure: Reflexology<br>* 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<br>|
| No Intervention: control group<br>The control group is given routine care and no intervention will be performed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale | Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain) | 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 | Ankle-brachial index is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toe oxygen saturation level | Toe oxygen saturation level is measured pulse oximetry. This method used to examine oxygen saturation in various parts of body. | 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. | 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. | Baseline, after 2 days second reflexology sessions |