Foot Reflexology and Pain and Ankle Brachial Index

Sponsor
Baskent University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06001203
Collaborator
(none)
52
1
2
5.5
9.4

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Reflexology
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Foot Reflexology on Pain and Ankle Brachial Index Level in Patients With Peripheral Artery Disease
Actual Study Start Date :
Jul 15, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Numeric Pain Rating Scale [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)

  2. Ankle Brachial Index [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 Outcome Measures

  1. 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]

    Toe oxygen saturation level is measured pulse oximetry. This method used to examine oxygen saturation in various parts of body.

  2. 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]

    Rate of Participants Edema level is measured from the ankle and calf with a tape measure.

  3. Walking Impairment Questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baskent University Ankara Etimesgut Turkey

Sponsors and Collaborators

  • Baskent University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elif BUDAK ERTÜRK, Assistant Professor, Baskent University
ClinicalTrials.gov Identifier:
NCT06001203
Other Study ID Numbers:
  • KA23-152
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023