Back to resultsFoot Reflexology and Pain and Ankle Brachial Index
Primary Purpose
Peripheral Arterial Disease
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reflexology
Sponsored by
About this trial
This is an interventional supportive care trial for Peripheral Arterial Disease
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
Sites / Locations
- Baskent UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
The intervention group is received two reflexology sessions.
The control group is given routine care and no intervention will be performed.
Outcomes
Primary Outcome Measures
Numeric Pain Rating Scale
Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)
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.
Secondary Outcome Measures
Toe oxygen saturation level
Toe oxygen saturation level is measured pulse oximetry. This method used to examine oxygen saturation in various parts of body.
Rate of Participants Edema level
Rate of Participants Edema level is measured from the ankle and calf with a tape measure.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06001203
Brief Title
Foot Reflexology and Pain and Ankle Brachial Index
Official Title
The Effect of Foot Reflexology on Pain and Ankle Brachial Index Level in Patients With Peripheral Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
The intervention group is received two reflexology sessions.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group is given routine care and no intervention will be performed.
Intervention Type
Procedure
Intervention Name(s)
Reflexology
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)
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
Title
Ankle Brachial Index
Description
Ankle-brachial index is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery.
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
Secondary Outcome Measure Information:
Title
Toe oxygen saturation level
Description
Toe oxygen saturation level is measured pulse oximetry. This method used to examine oxygen saturation in various parts of body.
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
Title
Rate of Participants Edema level
Description
Rate of Participants Edema level is measured from the ankle and calf with a tape measure.
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
Title
Walking Impairment Questionnaire
Description
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.
Time Frame
Baseline, after 2 days second reflexology sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elif BUDAK ERTÜRK, PhD, RN
Phone
+90-312-246-66-66
Ext
1598
Email
elifbudakerturk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sevcan AVCI IŞIK, PhD, RN
Phone
+90-312-246-66-66
Ext
1535
Email
sevcanhunter@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif BUDAK ERTÜRK, PhD, RN
Organizational Affiliation
Baskent University Faculty of Health Science Department of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baskent University
City
Ankara
State/Province
Etimesgut
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elif Budak Ertürk, PhD, RN
Phone
+903122466666
Ext
1598
Email
elifbudakerturk@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Foot Reflexology and Pain and Ankle Brachial Index
We'll reach out to this number within 24 hrs