<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/NCT04473287</url>
  </required_header>
  <id_info>
    <org_study_id>2020-10/35</org_study_id>
    <nct_id>NCT04473287</nct_id>
  </id_info>
  <brief_title>The Effect of Reflexology After Coronary Artery Bypass Graft Surgery</brief_title>
  <official_title>The Effect of Reflexology Applied to Patients Undergoing Coronary Artery Bypass Graft Surgery on Pain, Anxiety, Fatigue and Sleep: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saglik Bilimleri Universitesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saglik Bilimleri Universitesi</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Coronary artery bypass graft (CABG) surgery is a treatment method that increases survival&#xD;
      rate in the treatment of coronary artery disease (CAD). CABG surgery can create anxiety,&#xD;
      fear, pain, fatigue, sleep disorders and physiological dysfunctions in patients. Nurses&#xD;
      responsible for the care and treatment of patients use pharmacological and&#xD;
      non-pharmacological methods to alleviate the problems that arise. In this context,&#xD;
      reflexology within complementary and alternative therapy (CAM) can be applied. In this study,&#xD;
      it is aimed to evaluate the effect of reflexology applied to patients undergoing coronary&#xD;
      artery bypass graft surgery on pain, anxiety, fatigue, sleep and physiological parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the literature, there are a limited number of studies on the effect of reflexology applied&#xD;
      on patients undergoing CABG surgery on anxiety and physiological parameters. In addition, no&#xD;
      studies on the effect of reflexology on sleep on patients undergoing CABG surgery have been&#xD;
      encountered. Anxiety, stress, pain, fatigue, sleep disorders and permanent symptoms may occur&#xD;
      in individuals after cardiovascular surgery. It has been determined that with the&#xD;
      deterioration in the body system functions and the resulting psychological problems, the&#xD;
      blood pressure, heart rhythm and the number of breaths in the individual, respiratory and&#xD;
      coughing difficulties due to pain inactivity, body temperature changes, muscle tension,&#xD;
      fatigue and even death can occur. With the application of reflexology, the work of the body&#xD;
      systems is regulated by providing homeostasis, physiological and psychological relaxation and&#xD;
      relaxation are felt with the energy flow that occurs in the body, and toxins are removed from&#xD;
      the body. In this study, it is thought that reflexology application to patients undergoing&#xD;
      CABG surgery on nursing care will contribute to the nursing literature by examining the&#xD;
      effect of reflexology on pain, anxiety, fatigue, sleep and physiological parameters. The&#xD;
      population of the study will be the patients who underwent CABG surgery in the Cardiovascular&#xD;
      Intensive Care Unit and Cardiovascular Surgery Clinic of Uludağ University Health Practice&#xD;
      and Research Center Hospital. The sample will be composed of patients undergoing CABG surgery&#xD;
      in Uludag University Health Practice and Research Center Hospital Cardiovascular Surgery&#xD;
      Department Cardiovascular Intensive Care Unit and Cardiovascular Surgery Clinic that meet the&#xD;
      inclusion criteria. Data will be collected using Personal Information Form, Physiological&#xD;
      Parameters Control Form, Visual Analogue Scale, State Anxiety Scale, Richard's Campbell Sleep&#xD;
      Scale. The data obtained from the research will be analyzed using the SPSS (Statistical&#xD;
      Package for Social Sciences) for Windows 22.0 program. Number, percentage, average and&#xD;
      standard deviation will be used as descriptive statistical methods in the evaluation of the&#xD;
      data. The t-test will be used to compare quantitative continuous data between two independent&#xD;
      groups. Differences between repeated measurements will be analyzed by repeated measurements&#xD;
      ANOVA test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change on pain intensity as measured by Visual Analog Scale</measure>
    <time_frame>''just before procedure'' and ''30 minutes after procedure''</time_frame>
    <description>The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change on fatigue intensity as measured by Visual Analog Scale</measure>
    <time_frame>''just before procedure'' and ''30 minutes after procedure''</time_frame>
    <description>The average score change on fatigue intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure fatigue intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that fatigue intensity is high.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score change on anxiety level as measured by State-Trait Anxiety Inventory</measure>
    <time_frame>''just before procedure'' and ''30 minutes after procedure''</time_frame>
    <description>The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale in used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score change on sleep quality as measured by Richard's Campbell Sleep Scale</measure>
    <time_frame>''just before procedure'' and ''30 minutes after procedure''</time_frame>
    <description>The average score change on sleep quality as measured by Richard's Campbell Sleep Scale. This scale in used to measure sleep quality. The scores on the scale ranges from 0 to 100. The high scores on the scale indicate that sleep quality is high.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Coronary Artery Bypass Graft Surgery</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reflexology was applied to the intervention group during the procedure for 45 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Reflexology was not applied to the control group during the procedure. The control group received standard care and treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>reflexology practice</intervention_name>
    <description>Reflexology is a reliable and holistic complementary and alternative treatment method that means that the body's specific glands, organs and regions are stimulated by applying a special pressure with the fingers on the hands, feet and ears. When the literature is analyzed, it has been determined that reflexology is applied effectively before, during and after surgery, including different surgical procedures, and it is emphasized that one of the most important areas is patients who underwent Coronary Artery Bypass Graft (CABG) surgery. In this study, it is thought that reflexology application to patients undergoing CABG surgery on nursing care will contribute to the nursing literature by examining the effect of reflexology on pain, anxiety, fatigue, sleep and physiological parameters.</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being between the ages of 18-65&#xD;
&#xD;
          -  Having undergone CABG surgery for the first time&#xD;
&#xD;
          -  CABG has not been operated in an emergency&#xD;
&#xD;
          -  Lack of reflexology history&#xD;
&#xD;
          -  Not taking inotropic drugs At least 4 hours have passed since the application of the&#xD;
             last analgesic drug&#xD;
&#xD;
          -  Mental insufficiency and no vision, hearing impairment&#xD;
&#xD;
          -  Place, time and person orientation&#xD;
&#xD;
          -  Psychological treatment and drug use for this purpose&#xD;
&#xD;
          -  Participants agree to participate in the research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Decreased level of consciousness&#xD;
&#xD;
          -  Valve repair or replacement during CABG surgery Need for intraaortic balloon and&#xD;
             pacemaker&#xD;
&#xD;
          -  Drainage over 200 ml per hour&#xD;
&#xD;
          -  Having a history of chronic pain&#xD;
&#xD;
          -  Being addicted to alcohol and drugs&#xD;
&#xD;
          -  Bone fractures, sensory disorders, skin infections, skin ulcers in the feet&#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>Elif Gezginci, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sağlık Bilimleri Üniversitesi, Turkey</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sağlık Bilimleri University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://jmums.mazums.ac.ir/files/site1/user_files_0d0bf0/bmahmadi-A-10-1768-57-5d57eec.pdf</url>
    <description>The Effects of Foot Reflexology Massage on Pain and Fatigue of Patients After Coronary Artery Bypass Graft</description>
  </link>
  <link>
    <url>http://hacettepehemsirelikdergisi.org/pdf/pdf_HHD_230.pdf</url>
    <description>An Alternative Method for Labor Pain: Foot Reflexology</description>
  </link>
  <results_reference>
    <citation>Bagheri-Nesami M, Shorofi SA, Zargar N, Sohrabi M, Gholipour-Baradari A, Khalilian A. The effects of foot reflexology massage on anxiety in patients following coronary artery bypass graft surgery: a randomized controlled trial. Complement Ther Clin Pract. 2014 Feb;20(1):42-7. doi: 10.1016/j.ctcp.2013.10.006. Epub 2013 Oct 25.</citation>
    <PMID>24439644</PMID>
  </results_reference>
  <results_reference>
    <citation>Abbaszadeh Y, Allahbakhshian A, Seyyedrasooli A, Sarbakhsh P, Goljarian S, Safaei N. Effects of foot reflexology on anxiety and physiological parameters in patients undergoing coronary artery bypass graft surgery: A clinical trial. Complement Ther Clin Pract. 2018 May;31:220-228. doi: 10.1016/j.ctcp.2018.02.018. Epub 2018 Mar 3.</citation>
    <PMID>29705459</PMID>
  </results_reference>
  <results_reference>
    <citation>Tully PJ, Bennetts JS, Baker RA, McGavigan AD, Turnbull DA, Winefield HR. Anxiety, depression, and stress as risk factors for atrial fibrillation after cardiac surgery. Heart Lung. 2011 Jan-Feb;40(1):4-11. doi: 10.1016/j.hrtlng.2009.12.010. Epub 2010 May 8.</citation>
    <PMID>20561864</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 5, 2021</last_update_submitted>
  <last_update_submitted_qc>July 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
    <investigator_full_name>Elif Gezginci</investigator_full_name>
    <investigator_title>RN, PhD, Asst Prof.</investigator_title>
  </responsible_party>
  <keyword>reflexology, pain, anxiety, fatigue, sleep</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04473287
org study id: 2020-10/35
nct id: NCT04473287
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Coronary artery bypass graft (CABG) surgery is a treatment method that increases survival
      rate in the treatment of coronary artery disease (CAD). CABG surgery can create anxiety,
      fear, pain, fatigue, sleep disorders and physiological dysfunctions in patients. Nurses
      responsible for the care and treatment of patients use pharmacological and
      non-pharmacological methods to alleviate the problems that arise. In this context,
      reflexology within complementary and alternative therapy (CAM) can be applied. In this study,
      it is aimed to evaluate the effect of reflexology applied to patients undergoing coronary
      artery bypass graft surgery on pain, anxiety, fatigue, sleep and physiological parameters.
In the literature, there are a limited number of studies on the effect of reflexology applied
      on patients undergoing CABG surgery on anxiety and physiological parameters. In addition, no
      studies on the effect of reflexology on sleep on patients undergoing CABG surgery have been
      encountered. Anxiety, stress, pain, fatigue, sleep disorders and permanent symptoms may occur
      in individuals after cardiovascular surgery. It has been determined that with the
      deterioration in the body system functions and the resulting psychological problems, the
      blood pressure, heart rhythm and the number of breaths in the individual, respiratory and
      coughing difficulties due to pain inactivity, body temperature changes, muscle tension,
      fatigue and even death can occur. With the application of reflexology, the work of the body
      systems is regulated by providing homeostasis, physiological and psychological relaxation and
      relaxation are felt with the energy flow that occurs in the body, and toxins are removed from
      the body. In this study, it is thought that reflexology application to patients undergoing
      CABG surgery on nursing care will contribute to the nursing literature by examining the
      effect of reflexology on pain, anxiety, fatigue, sleep and physiological parameters. The
      population of the study will be the patients who underwent CABG surgery in the Cardiovascular
      Intensive Care Unit and Cardiovascular Surgery Clinic of Uludağ University Health Practice
      and Research Center Hospital. The sample will be composed of patients undergoing CABG surgery
      in Uludag University Health Practice and Research Center Hospital Cardiovascular Surgery
      Department Cardiovascular Intensive Care Unit and Cardiovascular Surgery Clinic that meet the
      inclusion criteria. Data will be collected using Personal Information Form, Physiological
      Parameters Control Form, Visual Analogue Scale, State Anxiety Scale, Richard's Campbell Sleep
      Scale. The data obtained from the research will be analyzed using the SPSS (Statistical
      Package for Social Sciences) for Windows 22.0 program. Number, percentage, average and
      standard deviation will be used as descriptive statistical methods in the evaluation of the
      data. The t-test will be used to compare quantitative continuous data between two independent
      groups. Differences between repeated measurements will be analyzed by repeated measurements
      ANOVA test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change on pain intensity as measured by Visual Analog Scale
time frame: ''just before procedure'' and ''30 minutes after procedure''
description: The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.
measure: Change on fatigue intensity as measured by Visual Analog Scale
time frame: ''just before procedure'' and ''30 minutes after procedure''
description: The average score change on fatigue intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure fatigue intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that fatigue intensity is high.
measure: Score change on anxiety level as measured by State-Trait Anxiety Inventory
time frame: ''just before procedure'' and ''30 minutes after procedure''
description: The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale in used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.
measure: Score change on sleep quality as measured by Richard's Campbell Sleep Scale
time frame: ''just before procedure'' and ''30 minutes after procedure''
description: The average score change on sleep quality as measured by Richard's Campbell Sleep Scale. This scale in used to measure sleep quality. The scores on the scale ranges from 0 to 100. The high scores on the scale indicate that sleep quality is high.
arm group label: intervention group
arm group type: Experimental
description: Reflexology was applied to the intervention group during the procedure for 45 minutes.
arm group label: control group
arm group type: No Intervention
description: Reflexology was not applied to the control group during the procedure. The control group received standard care and treatment.
intervention type: Other
intervention name: reflexology practice
description: Reflexology is a reliable and holistic complementary and alternative treatment method that means that the body's specific glands, organs and regions are stimulated by applying a special pressure with the fingers on the hands, feet and ears. When the literature is analyzed, it has been determined that reflexology is applied effectively before, during and after surgery, including different surgical procedures, and it is emphasized that one of the most important areas is patients who underwent Coronary Artery Bypass Graft (CABG) surgery. In this study, it is thought that reflexology application to patients undergoing CABG surgery on nursing care will contribute to the nursing literature by examining the effect of reflexology on pain, anxiety, fatigue, sleep and physiological parameters.
arm group label: intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Elif Gezginci, RN, PhD
role: Principal Investigator
affiliation: Sağlık Bilimleri Üniversitesi, Turkey
facility: 
country: Turkey
url: http://jmums.mazums.ac.ir/files/site1/user_files_0d0bf0/bmahmadi-A-10-1768-57-5d57eec.pdf
description: The Effects of Foot Reflexology Massage on Pain and Fatigue of Patients After Coronary Artery Bypass Graft
url: http://hacettepehemsirelikdergisi.org/pdf/pdf_HHD_230.pdf
description: An Alternative Method for Labor Pain: Foot Reflexology
citation: Bagheri-Nesami M, Shorofi SA, Zargar N, Sohrabi M, Gholipour-Baradari A, Khalilian A. The effects of foot reflexology massage on anxiety in patients following coronary artery bypass graft surgery: a randomized controlled trial. Complement Ther Clin Pract. 2014 Feb;20(1):42-7. doi: 10.1016/j.ctcp.2013.10.006. Epub 2013 Oct 25.
PMID: 24439644
citation: Abbaszadeh Y, Allahbakhshian A, Seyyedrasooli A, Sarbakhsh P, Goljarian S, Safaei N. Effects of foot reflexology on anxiety and physiological parameters in patients undergoing coronary artery bypass graft surgery: A clinical trial. Complement Ther Clin Pract. 2018 May;31:220-228. doi: 10.1016/j.ctcp.2018.02.018. Epub 2018 Mar 3.
PMID: 29705459
citation: Tully PJ, Bennetts JS, Baker RA, McGavigan AD, Turnbull DA, Winefield HR. Anxiety, depression, and stress as risk factors for atrial fibrillation after cardiac surgery. Heart Lung. 2011 Jan-Feb;40(1):4-11. doi: 10.1016/j.hrtlng.2009.12.010. Epub 2010 May 8.
PMID: 20561864
responsible party type: Principal Investigator
investigator affiliation: Saglik Bilimleri Universitesi
investigator full name: Elif Gezginci
investigator title: RN, PhD, Asst Prof.
sharing ipd: No