<?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>IRCT2014121520326N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-08</date_registration>
      <primary_sponsor>north khorasan univesity of medical sciences</primary_sponsor>
      <public_title>Effects of Effleurage Massage on physiological stress in hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Effleurage Massage on Intensity of  physiological stress associated with the treatment in  hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-02-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>41</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18033</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Inclusion criteria in this study  were (A minimum of six months of dialysis, be able to communicate verbally and age above 18 years, no candidate for a kidney transplant and no history of physical stress (damage) and psychological (bereavement, grief, etc.) do not have a pacemaker, lack upper and lower limb amputation and even drugs are associated with mental . Then consent form to be filled. 20 cases of patients who have conditions of entry will be randomly selected. Then, in a briefing before the intervention demographic  and (HSS)  questionnaire  will be completed. For each experimental group, in addition to the initial meetingTwo sessions will be held in private. Initially, the researcher training effleurage massage to care giver of  patient.Three types of massage on the back ,Two neck massage, four hand massage and   four  foot massage.  In addition,individuals will be given booklets. Each training session is 30 minutes.Therapeutic massage is a total of 12 sessions (each session twenty minutes)&#13;
And one hour before bedtime is planned. Complete and  delivery the questionnaire (HSS)  by  patients during a 4-week . Exclusion criteria unwillingness to continue the experimental ,use of drugs affecting mental illness, and hospitalization for any reason, surgery and infection in the study. Intervention 2: Inclusion criteria in this study  were (A minimum of six months of dialysis, be able to communicate verbally and age above 18 years, no candidate for a kidney transplant and no history of physical stress (damage) and psychological (bereavement, grief, etc.) do not have a pacemaker, lack upper and lower limb amputation and even drugs are associated with mental . Then consent form to be filled. 21 cases of patients who have conditions of entry will be randomly selected. Then, in a briefing before the intervention demographic  and (HSS)  questionnaire  will be completed. No intervention for patients in the control group. Complete and  delivery the questionnaire (HSS)  by  patients during a 4-week . Exclusion criteria unwillingness to continue the experimental ,use of drugs affecting mental illness, and hospitalization for any reason, surgery and infection in the study.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdieh Arian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Building of the Central of north khorasan univesity of medical sciences, Dolat Bulvar, Bojnoord, north khorasan,Iran</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 58 3226 9909</telephone>
        <email>m.arian@nkums.ac.ir; arianyem@gmail.com</email>
        <affiliation>North Khorasan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdieh Arian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Building of the Central of north khorasan univesity of medical sciences, Dolat Bulvar, Bojnoord, north khorasan,Iran</address>
        <city>Bojnord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 58 3229 6909</telephone>
        <email>m.arian@nkums.ac.ir; arianyem@gmail.com</email>
        <affiliation>North Khorasan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: at least six months of dialysis; ablility to communicate verbally; age over 18 years old; not being candidate for a kidney transplant; no history of physical stress (damage) and psychological (bereavement, grief, etc.); not having pacemaker; no amputation in lower or upper extermities; not taking psychiatric treatment medications.&#13;
 Exclusion criteria: unwillingness to continue in the study; use of drugs affecting mental illness, admission in hospital for any reason; surgery and infection during the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Extracorporeal dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Inclusion criteria in this study  were (A minimum of six months of dialysis, be able to communicate verbally and age above 18 years, no candidate for a kidney transplant and no history of physical stress (damage) and psychological (bereavement, grief, etc.) do not have a pacemaker, lack upper and lower limb amputation and even drugs are associated with mental . Then consent form to be filled. 20 cases of patients who have conditions of entry will be randomly selected. Then, in a briefing before the intervention demographic  and (HSS)  questionnaire  will be completed. For each experimental group, in addition to the initial meetingTwo sessions will be held in private. Initially, the researcher training effleurage massage to care giver of  patient.Three types of massage on the back ,Two neck massage, four hand massage and   four  foot massage.  In addition,individuals will be given booklets. Each training session is 30 minutes.Therapeutic massage is a total of 12 sessions (each session twenty minutes)&#13;
And one hour before bedtime is planned. Complete and  delivery the questionnaire (HSS)  by  patients during a 4-week . Exclusion criteria unwillingness to continue the experimental ,use of drugs affecting mental illness, and hospitalization for any reason, surgery and infection in the study</i_keyword>
      <i_keyword>Inclusion criteria in this study  were (A minimum of six months of dialysis, be able to communicate verbally and age above 18 years, no candidate for a kidney transplant and no history of physical stress (damage) and psychological (bereavement, grief, etc.) do not have a pacemaker, lack upper and lower limb amputation and even drugs are associated with mental . Then consent form to be filled. 21 cases of patients who have conditions of entry will be randomly selected. Then, in a briefing before the intervention demographic  and (HSS)  questionnaire  will be completed. No intervention for patients in the control group. Complete and  delivery the questionnaire (HSS)  by  patients during a 4-week . Exclusion criteria unwillingness to continue the experimental ,use of drugs affecting mental illness, and hospitalization for any reason, surgery and infection in the study</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physiological stress. Timepoint: each week for 4 weeks. Method of measurement: questionnaire  Hemodialys is Stress Scale(HSS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Muscle cramps, fatigue, itching, joint stiffness, soreness  caused by inserting the needle, nausea and diarrhea and constipation. Timepoint: each week for 4 weeks. Method of measurement: questionnaire  Hemodialys is Stress Scale(HSS).</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>north khorasan univesity of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-03-05</approval_date>
        <contact_name>North Khorasan University of  Medical Sciences, Bojnurd,Iran</contact_name>
        <contact_address>Building of the Central of north khorasan univesity of medical sciences Bojnurd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
