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Clinical Trials/NCT06001203
NCT06001203
Completed
Not Applicable

The Effect of Foot Reflexology on Pain, Walking Impairement and Ankle Brachial Index Level in Patients With Peripheral Artery Disease

Baskent University1 site in 1 country30 target enrollmentJuly 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
Baskent University
Enrollment
30
Locations
1
Primary Endpoint
Numeric Pain Rating Scale
Status
Completed
Last Updated
11 months ago

Overview

Brief 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

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2023
End Date
January 30, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elif BUDAK ERTÜRK

Assistant Professor

Baskent University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Toe oxygen saturation level(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(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)

Study Sites (1)

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