<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20170116031972N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-03</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of foot reflexology on patients undergoing renal transplantation surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Foot reflexology on pain, fatigue, and sleep quality of patients undergoing renal transplantation surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31687</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples will be divided into the intervention and control group using the method of Minimization. Samples will be allocated to two groups according to gender variable and age (±2). In other words, the first sample is randomly assigned (using coin flipping or heads or tails) to one of the intervention or control groups, and the subsequent sample is allocated to the other group according to the matching variables (gender and age (±2)). If the subsequent sample would not match with the previous sample, it will be randomly assigned (using coin flipping or heads or tails) to one of the intervention or control groups using coin flipping or heads or tails. This process will continue until the sampling end so that at the end of the sampling, the two groups will be similar in age (±2) and gender.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Patients' pain after renal transplantation surgery. Condition 2: Patients' fatigue after renal transplantation surgery. Condition 3: Patients' sleep quality after renal transplantation surgery. Condition 4: Kidney transplant.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Massaging intervention starts from the second day after the surgery. The massaging session starts in the final hours of the evening shift, at least 4 hours after the last time the sample received the last sedative. First,  a quiet and bright environment will be prepared for the sample. Then massaging starts, first, the sole of the foot is gently massaged, gentle massage takes place in 3 minutes of the beginning and the final minutes of the intervention. The researcher takes the heel of one of the feet in his/her left hand and with the right-hand thumb applies​ pressure on the corresponding reflex points. The researcher, with his palm, pulls and pushes the outer edge of the foot forward and backward. For those samples who rarely go to the relaxation state, the solar plexus in the sole of the foot is also massaged to make the sample relax. Also, the parts related to the pineal gland are massaged in the outer part of the toe with slow speed and with regular rhythm or depth that is tolerable to the sample. The protocol is performed for 30 minutes on both feet (15 minutes each) for 3 sessions in 3 consecutive days.​. Intervention 2: Control group: In the control group, the researcher will do nothing and nurses will do caring procedures according to the protocol​ of the ward.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atena Samareh fekri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi School of Nursing and Midwifery, Haft Baghe Alavi</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7817831151</zip>
        <telephone>+98 34 3211 3491</telephone>
        <email>atena.samarehfekri@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahlagha Dehghan Anari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5856</telephone>
        <email>m_dehghan86@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>‌Being at least 15 years old
Having kidney transplant for the first time
Having no problems in feet, especially the sole
Having full vigilance after the surgery
No drug or alcohol addiction
Patients undergoing renal transplantation surgery</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>‌Being blind or deaf
Having the experience of using foot reflexology</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.0</hc_code>
      <hc_code>R53</hc_code>
      <hc_code>G47.9</hc_code>
      <hc_code>Z94.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain</hc_keyword>
      <hc_keyword>Malaise and fatigue</hc_keyword>
      <hc_keyword>Sleep disorder, unspecified</hc_keyword>
      <hc_keyword>Kidney transplant status</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Massaging intervention starts from the second day after the surgery. The massaging session starts in the final hours of the evening shift, at least 4 hours after the last time the sample received the last sedative. First,  a quiet and bright environment will be prepared for the sample. Then massaging starts, first, the sole of the foot is gently massaged, gentle massage takes place in 3 minutes of the beginning and the final minutes of the intervention. The researcher takes the heel of one of the feet in his/her left hand and with the right-hand thumb applies​ pressure on the corresponding reflex points. The researcher, with his palm, pulls and pushes the outer edge of the foot forward and backward. For those samples who rarely go to the relaxation state, the solar plexus in the sole of the foot is also massaged to make the sample relax. Also, the parts related to the pineal gland are massaged in the outer part of the toe with slow speed and with regular rhythm or depth that is tolerable to the sample. The protocol is performed for 30 minutes on both feet (15 minutes each) for 3 sessions in 3 consecutive days.​</i_keyword>
      <i_keyword>Control group: In the control group, the researcher will do nothing and nurses will do caring procedures according to the protocol​ of the ward.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient's​ pain score in Visual Analog Scale (VAS). Timepoint: The first day after surgery, the second day after surgery before the ​intervention, immediately after the final session of intervention and one week after the final session of intervention. Method of measurement: Visual Analog Scale (VAS).</prim_outcome>
      <prim_outcome>Patient's​ fatigue score in Visual Analog Scale (VAS). Timepoint: The first day after surgery, the second day after surgery before the intervention, immediately after the final session of intervention and one week after the final session of intervention. Method of measurement: Visual Analog Scale (VAS).</prim_outcome>
      <prim_outcome>Patient's​ sleep quality score in Pittsburgh Sleep Quality Index (PSQI). Timepoint: The first day after surgery, the second day after surgery before the intervention, immediately after the final session of intervention and one week after the final session of intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-28</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Ebnesina St, Jahad Blvd, Somaye Crossroad, Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
