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/NCT06007716</url>
    </required_header>
    <id_info>
      <org_study_id>HU-SM-KM-01</org_study_id>
      <nct_id>NCT06007716</nct_id>
    </id_info>
    <brief_title>The Effect Of Reflexology On Pain, Anxiety And Comfort Level</brief_title>
    <official_title>The Effect Of Reflexology Massage On Pain, Anxiety And Comfort Level In Patients Undergoing Percutaneous Coronary Intervention</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hakkari Universitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hakkari Universitesi</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 study was performed as a randomized controlled a study with a pre test-post test design,&#xD;
        aimed to determine affect of reflexology masagge to the pain, anxiety and comfort level on&#xD;
        the patients that are percutaneous coronary intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 74 patients, 37 in the experimental group and 37 in the placebo group, who met the&#xD;
        criteria for inclusion in the study, constituted the sample of the study. Research data were&#xD;
        collected with &quot;Structured Patient Information Form&quot;, &quot;Vital Signs Form&quot;, &quot;State Anxiety&#xD;
        Scale&quot;, &quot;Visual Comparison Scale&quot;, &quot;McGill Pain Scale Short Form&quot; and &quot;General Comfort Scale&#xD;
        Short Form&quot;. Appropriate statistical methods were used in the analysis of the data.&#xD;
  &#xD;
        Reflexology massage is a well tolerated, inexpensive, applicable and safe non-pharmacological&#xD;
        method. The fact that nurses are educated and experienced about reflexology massage is of&#xD;
        great importance for integrating reflexology massage into clinical settings.&#xD;
  &#xD;
        If the results of this study are significant, it will be concluded that reflexology massage&#xD;
        is effective in the management of pain and anxiety and increasing the comfort level in&#xD;
        patients undergoing PCI. It will be recommended that reflexology massage be used in clinics&#xD;
        to reduce pain, anxiety and increase comfort level in individuals undergoing PCI, and to&#xD;
        include it in patient education. No study has been found in the national literature&#xD;
        evaluating the effectiveness of reflexology massage in the management of PCI-related pain,&#xD;
        anxiety and comfort. It is thought that this study will fill an important gap in the&#xD;
        literature. The aim of this study, carried out in this context, is to reveal the effect of&#xD;
        reflexology massage on pain, anxiety and comfort level in patients undergoing PCI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 1, 2021</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Actual">February 27, 2022</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>
      <intervention_model_description>consists of experimental and placebo groups.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participants were informed about the study after obtaining an informed consent form. It was noted that the participants had not received reflexology or classical massage before.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The McGill Pain Scale Short Form-2</measure>
      <time_frame>2 days</time_frame>
      <description>The McGill Pain Scale Short Form, developed by Melzack in 1987, provides information about the sensory characteristics, severity and effect of pain. The validity and reliability study in Turkey was developed by Yakut et al. in 2007. McGill Pain Scale Short Form-2 (MAS-SF-2) was developed in 2010 by revising the McGill Pain Scale Short Form by Bicici and Günes.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>State-Trait Anxiety Inventory</measure>
      <time_frame>2 days</time_frame>
      <description>It was developed by Spielberger et al. in 1970 and validated and reliable in Turkish society by Öner and Le Compte (1977). The State-Trait Anxiety Inventory consists of two different parts and includes a total of 40 items, 20 of which are each.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>General Comfort Scale Short Form</measure>
      <time_frame>2 days</time_frame>
      <description>General Comfort Scale Short Form GQS-SF was developed by Kolcaba in 2006. Validity and reliability were established by Saritas et al. in 2018. It includes the sub-dimensions of comfort, relief (9 items), relaxation (9 items), and overcoming problems (10 items).</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">74</enrollment>
    <condition>Myocardial Infarction</condition>
    <condition>Angina Pectoris</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>it was planned to apply reflexology massage once a day for each patient for 2 consecutive days, in total 2 sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>placebo massage was applied once a day for each patient for 2 consecutive days, for a total of 2 sessions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>reflexology massage</intervention_name>
      <description>5 minutes of classic message on the left foot, 15 minutes of reflexology message, and 5 minutes of classic message on the right foot, 15 minutes of reflexology message, a total of 40 minutes of massage. 30 minutes after the massage, evaluation was recorded with the Vital Signs Registration Form, McGill Pain Scale Short Form, State Anxiety Inventory, General Comfort Scale Short Form, and Fatigue and Quality Sleep Visual Comparison Scale. Thus, reflexology massage is performed once a day for each patient for 2 consecutive days, for a total of 2 sessions.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo massage</intervention_name>
      <description>Placebo reflexology massage was applied to each foot for 20 minutes, for a total of 40 minutes.30 minutes after the massage, evaluation was recorded with the Vital Signs Registration Form, McGill Pain Scale Short Form, State Anxiety Inventory, General Comfort Scale Short Form, and Fatigue and Quality Sleep Visual Comparison Scale. Thus, Placebo massage is performed once a day for each patient for 2 consecutive days, for a total of 2 sessions.</description>
      <arm_group_label>placebo group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Over 18 years old,&#xD;
  &#xD;
            -  Literate, Diagnosed with PCI-related pain,&#xD;
  &#xD;
            -  Pain score of 4 out of 10 according to Visual Comparison Scale (VAS) after PCI.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of a pacemaker,&#xD;
  &#xD;
            -  Having a diagnosis of diabetic foot,&#xD;
  &#xD;
            -  Presence of vision, hearing, cognitive ability impairment or psychosis,&#xD;
  &#xD;
            -  Being pregnant,&#xD;
  &#xD;
            -  Presence of disc herniation,&#xD;
  &#xD;
            -  Any contagious skin disease (shingles, fungus, etc.), open lesion/wound on the lower&#xD;
               extremities, scar tissue, fracture, dislocation, amputation, edema, hematoma,&#xD;
               thrombophlebitis, inflammatory and degenerative joint disease,&#xD;
  &#xD;
            -  Having applied reflexology massage in the last month&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kamber SÜMER</last_name>
      <role>Principal Investigator</role>
      <affiliation>PhD student</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Van Regional Training and Research Hospital</name>
        <address>
          <city>Van</city>
          <zip>65100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hakkari Universitesi</investigator_affiliation>
      <investigator_full_name>Kamber Sumer</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>Myocardial Infarction</mesh_term>
      <mesh_term>Angina Pectoris</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06007716
  org study id: HU-SM-KM-01
  nct id: NCT06007716
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was performed as a randomized controlled a study with a pre test-post test design,
        aimed to determine affect of reflexology masagge to the pain, anxiety and comfort level on
        the patients that are percutaneous coronary intervention.
  A total of 74 patients, 37 in the experimental group and 37 in the placebo group, who met the
        criteria for inclusion in the study, constituted the sample of the study. Research data were
        collected with "Structured Patient Information Form", "Vital Signs Form", "State Anxiety
        Scale", "Visual Comparison Scale", "McGill Pain Scale Short Form" and "General Comfort Scale
        Short Form". Appropriate statistical methods were used in the analysis of the data.
  
        Reflexology massage is a well tolerated, inexpensive, applicable and safe non-pharmacological
        method. The fact that nurses are educated and experienced about reflexology massage is of
        great importance for integrating reflexology massage into clinical settings.
  
        If the results of this study are significant, it will be concluded that reflexology massage
        is effective in the management of pain and anxiety and increasing the comfort level in
        patients undergoing PCI. It will be recommended that reflexology massage be used in clinics
        to reduce pain, anxiety and increase comfort level in individuals undergoing PCI, and to
        include it in patient education. No study has been found in the national literature
        evaluating the effectiveness of reflexology massage in the management of PCI-related pain,
        anxiety and comfort. It is thought that this study will fill an important gap in the
        literature. The aim of this study, carried out in this context, is to reveal the effect of
        reflexology massage on pain, anxiety and comfort level in patients undergoing PCI.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: consists of experimental and placebo groups.
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: Participants were informed about the study after obtaining an informed consent form. It was noted that the participants had not received reflexology or classical massage before.
  measure: The McGill Pain Scale Short Form-2
  time frame: 2 days
  description: The McGill Pain Scale Short Form, developed by Melzack in 1987, provides information about the sensory characteristics, severity and effect of pain. The validity and reliability study in Turkey was developed by Yakut et al. in 2007. McGill Pain Scale Short Form-2 (MAS-SF-2) was developed in 2010 by revising the McGill Pain Scale Short Form by Bicici and Günes.
  measure: State-Trait Anxiety Inventory
  time frame: 2 days
  description: It was developed by Spielberger et al. in 1970 and validated and reliable in Turkish society by Öner and Le Compte (1977). The State-Trait Anxiety Inventory consists of two different parts and includes a total of 40 items, 20 of which are each.
  measure: General Comfort Scale Short Form
  time frame: 2 days
  description: General Comfort Scale Short Form GQS-SF was developed by Kolcaba in 2006. Validity and reliability were established by Saritas et al. in 2018. It includes the sub-dimensions of comfort, relief (9 items), relaxation (9 items), and overcoming problems (10 items).
  arm group label: Experimental group
  arm group type: Active Comparator
  description: it was planned to apply reflexology massage once a day for each patient for 2 consecutive days, in total 2 sessions.
  arm group label: placebo group
  arm group type: Placebo Comparator
  description: placebo massage was applied once a day for each patient for 2 consecutive days, for a total of 2 sessions.
  intervention type: Other
  intervention name: reflexology massage
  description: 5 minutes of classic message on the left foot, 15 minutes of reflexology message, and 5 minutes of classic message on the right foot, 15 minutes of reflexology message, a total of 40 minutes of massage. 30 minutes after the massage, evaluation was recorded with the Vital Signs Registration Form, McGill Pain Scale Short Form, State Anxiety Inventory, General Comfort Scale Short Form, and Fatigue and Quality Sleep Visual Comparison Scale. Thus, reflexology massage is performed once a day for each patient for 2 consecutive days, for a total of 2 sessions.
  arm group label: Experimental group
  intervention type: Other
  intervention name: Placebo massage
  description: Placebo reflexology massage was applied to each foot for 20 minutes, for a total of 40 minutes.30 minutes after the massage, evaluation was recorded with the Vital Signs Registration Form, McGill Pain Scale Short Form, State Anxiety Inventory, General Comfort Scale Short Form, and Fatigue and Quality Sleep Visual Comparison Scale. Thus, Placebo massage is performed once a day for each patient for 2 consecutive days, for a total of 2 sessions.
  arm group label: placebo group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Kamber SÜMER
  role: Principal Investigator
  affiliation: PhD student
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Hakkari Universitesi
  investigator full name: Kamber Sumer
  investigator title: Assistant professor
  mesh term: Myocardial Infarction
  mesh term: Angina Pectoris
  mesh term: Infarction
  sharing ipd: No