<?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>IRCT2013112615552N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-02-23</date_registration>
      <primary_sponsor>Research Deputy Shiraz University</primary_sponsor>
      <public_title>Effect of back massage on Vital signs and anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effect of massage on anxiety and vital signs of patients with primary hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14793</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study randomization is done with table of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>essential hypertension..</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will rest for 5 minutes then  will be recorded vital signs,Vital signs before the intervention will be recorded 2 times per week for 6 weeks،Spielberger anxiety form، will be filled only 1 times in all 6 weeks, after 5 minutes of rest،Then in the intervention group, after applying an oily substance (sesame oil) 10 min back massage done  of the neck and the back (from shoulder to waist)،back massage will be done 2 times a week for 6 weeks for patients ،Then vital signs will be measured after a 10 minute massage, two times per week for 6 weeks and Spielberger anxiety form،will be filled immediately after the end of the first session, the end of weeks 3, 6, and 3 days after intervention for patients.as well as vital signs will be and control recorded، 3 days after the intervention. Intervention 2: The Control group will rest for 5 minutes then  will be recorded vital signs,Vital signs before the intervention will be recorded 2 times per week for 6 weeks،Spielberger anxiety form، will be filled only 1 times in all 6 weeks, after 5 minutes of rest،in the control group, patients will rest 10 minute ،Then vital signs will be measured after a 10 minute rest, two times per week for 6 weeks and Spielberger anxiety form،will be filled immediately after the end of the first session, the end of weeks 3, 6, and 3 days after intervention for patients.as well as vital signs will be and control recorded، 3 days after the intervention.</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>Mehdi Moghadasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 6, Gulshan Lane 4 , Street 15 meters Kaveh</address>
        <city>Borojerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 66 2444 0402</telephone>
        <email>mehdimoghadasi99@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zinat Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1647 4254</telephone>
        <email>mohebbi04@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age between 30 to 70 years ؛ History, is not of blood pressure drop skin disorders and spine؛ Non Anti-anxiety drugs and sedative؛ The absence of diabetes and hypertension disease (kidney problems, adrenal gland tumors, congenital heart defects) is effective.Exclusion Criteria: Back pain due to spinal cord injury, herniated or degenerating discs؛ Patients who have undergoing surgery lumbar؛ No Inclusion criteria.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10-115</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the circulatory system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will rest for 5 minutes then  will be recorded vital signs,Vital signs before the intervention will be recorded 2 times per week for 6 weeks،Spielberger anxiety form، will be filled only 1 times in all 6 weeks, after 5 minutes of rest،Then in the intervention group, after applying an oily substance (sesame oil) 10 min back massage done  of the neck and the back (from shoulder to waist)،back massage will be done 2 times a week for 6 weeks for patients ،Then vital signs will be measured after a 10 minute massage, two times per week for 6 weeks and Spielberger anxiety form،will be filled immediately after the end of the first session, the end of weeks 3, 6, and 3 days after intervention for patients.as well as vital signs will be and control recorded، 3 days after the intervention.</i_keyword>
      <i_keyword>The Control group will rest for 5 minutes then  will be recorded vital signs,Vital signs before the intervention will be recorded 2 times per week for 6 weeks،Spielberger anxiety form، will be filled only 1 times in all 6 weeks, after 5 minutes of rest،in the control group, patients will rest 10 minute ،Then vital signs will be measured after a 10 minute rest, two times per week for 6 weeks and Spielberger anxiety form،will be filled immediately after the end of the first session, the end of weeks 3, 6, and 3 days after intervention for patients.as well as vital signs will be and control recorded، 3 days after the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: blood pressure before and after the intervention, 2 times a week for 6 weeks and three days after the intervention was measured . Method of measurement: blood pressure With Digital manometer-mmHg.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: the level of anxiety before the first session and after the first session, after the third week, after six weeks and three days after the intervention, was measured. Method of measurement: Spielberger form.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: heart rate  before and after the intervention, 2 times a week for 6 weeks and three days after the intervention was measured. Method of measurement: per minute.</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>Research Deputy Shiraz University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-05-15</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>The central building of of Shiraz Medical University,St, Haft Tir,  Zand Street . Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
