Foot Reflexology and Pain and Ankle Brachial Index

The Effect of Foot Reflexology on Pain 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 and ankle brachial index level in patients with peripheral artery disease

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Reflexology

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

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elif BUDAK ERTÜRK, PhD, RN; Phone Number: 1598 +90-312-246-66-66; Email: elifbudakerturk@gmail.com
• Study Contact Backup: Name: Sevcan AVCI IŞIK, PhD, RN; Phone Number: 1535 +90-312-246-66-66; Email: sevcanhunter@gmail.com

Study Locations

• Turkey
  • Etimesgut
    • Ankara, Etimesgut, Turkey
      • Recruiting
      • Başkent University
      • Contact: Elif Budak Ertürk, PhD, RN; Phone Number: 1598 +903122466666; Email: elifbudakerturk@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baskent University
• Investigators: Principal Investigator: Elif BUDAK ERTÜRK, PhD, RN, Baskent University Faculty of Health Science Department of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: KA23-152

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No