xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06001203</url>
    </required_header>
    <id_info>
      <org_study_id>KA23-152</org_study_id>
      <nct_id>NCT06001203</nct_id>
    </id_info>
    <brief_title>Foot Reflexology and Pain and Ankle Brachial Index</brief_title>
    <official_title>The Effect of Foot Reflexology on Pain and Ankle Brachial Index Level in Patients With Peripheral Artery Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Baskent University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Baskent University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This randomized controlled study aimed to determine the effect of foot reflexology on pain&#xD;
        and ankle brachial index level in patients with peripheral artery disease&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with PAH may experience pain in the legs, cramps, pain or aching symptoms&#xD;
        (claudication) in the hip, thigh or leg calf, along with compulsive movements such as&#xD;
        walking. Reflexology is reported to have effects such as protecting the tissue integrity of&#xD;
        the feet, increasing skin turgor, reducing neuropathic pain and increasing peripheral blood&#xD;
        flow. For this reason, this study aimed to determine the effect of foot reflexology on pain&#xD;
        and ankle brachial index level in patients with peripheral artery disease.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 15, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Numeric Pain Rating Scale</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</time_frame>
      <description>Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ankle Brachial Index</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</time_frame>
      <description>Ankle-brachial index is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Toe oxygen saturation level</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</time_frame>
      <description>Toe oxygen saturation level is measured pulse oximetry. This method used to examine oxygen saturation in various parts of body.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Participants Edema level</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</time_frame>
      <description>Rate of Participants Edema level is measured from the ankle and calf with a tape measure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Walking Impairment Questionnaire</measure>
      <time_frame>Baseline, after 2 days second reflexology sessions</time_frame>
      <description>The &quot;Walking Impairment Questionnaire&quot; 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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">52</enrollment>
    <condition>Peripheral Arterial Disease</condition>
    <arm_group>
      <arm_group_label>intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group is received two reflexology sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group is given routine care and no intervention will be performed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Reflexology</intervention_name>
      <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</description>
      <arm_group_label>intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients over 18 years of age with PAH;&#xD;
  &#xD;
            -  no fractures or open wounds in both lower extremities;&#xD;
  &#xD;
            -  absence of unilateral or bilateral amputation of the lower extremities&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  having an acute infection with fever;&#xD;
  &#xD;
            -  requiring an acute surgical condition&#xD;
  &#xD;
            -  undergoing femoral-popliteal bypass surgery&#xD;
  &#xD;
            -  Having a verbal communication problem such as Alzheimer's or dementia&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Elif BUDAK ERTÜRK, PhD, RN</last_name>
      <role>Principal Investigator</role>
      <affiliation>Baskent University Faculty of Health Science Department of Nursing</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elif BUDAK ERTÜRK, PhD, RN</last_name>
      <phone>+90-312-246-66-66</phone>
      <phone_ext>1598</phone_ext>
      <email>elifbudakerturk@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sevcan AVCI IŞIK, PhD, RN</last_name>
      <phone>+90-312-246-66-66</phone>
      <phone_ext>1535</phone_ext>
      <email>sevcanhunter@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Baskent University</name>
        <address>
          <city>Ankara</city>
          <state>Etimesgut</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elif Budak Ertürk, PhD, RN</last_name>
        <phone>+903122466666</phone>
        <phone_ext>1598</phone_ext>
        <email>elifbudakerturk@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Baskent University</investigator_affiliation>
      <investigator_full_name>Elif BUDAK ERTÜRK</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Arterial Disease</mesh_term>
      <mesh_term>Peripheral Vascular Diseases</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06001203
  org study id: KA23-152
  nct id: NCT06001203
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  measure: Numeric Pain Rating Scale
  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
  description: Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)
  measure: Ankle Brachial Index
  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
  description: Ankle-brachial index is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery.
  measure: Toe oxygen saturation level
  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
  description: Toe oxygen saturation level is measured pulse oximetry. This method used to examine oxygen saturation in various parts of body.
  measure: Rate of Participants Edema level
  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
  description: Rate of Participants Edema level is measured from the ankle and calf with a tape measure.
  measure: Walking Impairment Questionnaire
  time frame: Baseline, after 2 days second reflexology sessions
  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.
  arm group label: intervention group
  arm group type: Experimental
  description: The intervention group is received two reflexology sessions.
  arm group label: control group
  arm group type: No Intervention
  description: The control group is given routine care and no intervention will be performed.
  intervention type: Procedure
  intervention name: Reflexology
  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
  arm group label: intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Elif BUDAK ERTÜRK, PhD, RN
  role: Principal Investigator
  affiliation: Baskent University Faculty of Health Science Department of Nursing
  last name: Elif BUDAK ERTÜRK, PhD, RN
  phone: +90-312-246-66-66
  phone ext: 1598
  email: elifbudakerturk@gmail.com
  last name: Sevcan AVCI IŞIK, PhD, RN
  phone: +90-312-246-66-66
  phone ext: 1535
  email: sevcanhunter@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Baskent University
  investigator full name: Elif BUDAK ERTÜRK
  investigator title: Assistant Professor
  mesh term: Peripheral Arterial Disease
  mesh term: Peripheral Vascular Diseases