Foot Reflexology and Pain and Ankle Brachial Index

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001203
• Other study ID #: KA23-152
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2023
• Source: Baskent University
• Contact: Elif BUDAK ERTÜRK, PhD, RN
• Phone: +90-312-246-66-66
• Email: elifbudakerturk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Turkey	Baskent University	Ankara	Etimesgut

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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