Foot Reflexology and Pain and Ankle Brachial Index and Walking Impairement

NCT06001203 | Completed

• 1 other identifier: KA23-152
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• 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 Arms (2)

intervention group

EXPERIMENTAL

The intervention group is received two reflexology sessions.

Procedure: Reflexology

control group

NO INTERVENTION

The control group is given routine care and no intervention will be performed.

Interventions

Reflexology PROCEDURE

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

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, Etimesgut, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Elif BUDAK ERTÜRK, PhD, RN

  Baskent University Faculty of Health Science Department of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 21, 2023
• Study Start: July 15, 2023
• Primary Completion: January 29, 2024
• Study Completion: January 30, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

TU (1)