<?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>IRCT2015030221307N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-05-13</date_registration>
      <primary_sponsor>Ahvaz Jundishapur University of Medical Science</primary_sponsor>
      <public_title>Effect of the massage therapy on the patients with acute blood cancer</public_title>
      <acronym></acronym>
      <scientific_title>Effect of the Slow Stroke Back Massage on the pain and fatigue severity in the patients with acute leukemia undergoing chemotherapy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18702</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Matching on the basis of age and gender. &#13;
Random allocation, the first three patients assigning to the intervention group and the second three patients to the control.</study_design>
      <phase>2</phase>
      <hc_freetext>Acute leukemia.</hc_freetext>
      <i_freetext>Both groups will receive the routine cares. The intervention group will be treated with slow stroke back massage.&#13;
1- The patient sits on a chair and leaned his head on the pillow, 2 - The small rotational movements with the thumb on the neck, 3- To stroke surface the base of the skull to the sacrum with the palm of a hand, and repeat the procedure on the other side of the spine with the other hand, While at it, the first hand moves toward the base of the skull, 4 – To do stoke on shoulder blades with thumb. 5 - Stroke with the thumb on either side of the spine from the shoulders to the waist, 6 - Stroke to sweep the neck to the sacrum with the palms of both hands..</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>Shahram Baraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing faculty, University of Medical Science, Golestan Blv, Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3373 8333</telephone>
        <email>shahrambaraz@yahoo.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojtaba Miladi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing faculty, University of Medical Science, Golestan Blv, Ahvaz, Iran</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3373 8333</telephone>
        <email>miladimojtaba@gmail.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: ages ranging from 18 to 50 years; pain and fatigue severity 3 or more (on the basis of numeric rating scale); no sign of clear and identified pain or fatigue disorders which are recorded in patients' files (pains from lumbar disc, spinal injuries, fractures, etc. and fatigue from Thalassemia, Sickle cell anemia, etc.); not having any background diseases (such as diabetes, peripheral nerves disease); the patients should have been under chemotherapy.&#13;
Exclusion criteria: absence in two sessions of massage therapy; discharge or death of the patient; and the patient's unwillingness to continue to participate in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C91.0, C92</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute lymphoblastic leukaemia [ALL], Acute myeloblastic leukaemia [AML]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Both groups will receive the routine cares. The intervention group will be treated with slow stroke back massage.&#13;
1- The patient sits on a chair and leaned his head on the pillow, 2 - The small rotational movements with the thumb on the neck, 3- To stroke surface the base of the skull to the sacrum with the palm of a hand, and repeat the procedure on the other side of the spine with the other hand, While at it, the first hand moves toward the base of the skull, 4 – To do stoke on shoulder blades with thumb. 5 - Stroke with the thumb on either side of the spine from the shoulders to the waist, 6 - Stroke to sweep the neck to the sacrum with the palms of both hands.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain severity. Timepoint: Before intervention, at the end of each week, after intervention. Method of measurement: Numeric rating scale (NRS).</prim_outcome>
      <prim_outcome>Fatigue severity. Timepoint: Before intervention, at the end of each week, after intervention. Method of measurement: Numeric rating scale (NRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea severity. Timepoint: Before intervention, at the end of each week, after intervention. Method of measurement: Numeric rating scale (NRS).</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before and after of intervention. Method of measurement: Short-Form 36 Health Survey (SF-36).</sec_outcome>
      <sec_outcome>Sleep quality. Timepoint: Before and after of intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).</sec_outcome>
      <sec_outcome>Mood disturbances. Timepoint: Before and after of intervention. Method of measurement: Beck Depression questionnaire and Spielberg Anxiety questionnaire.</sec_outcome>
      <sec_outcome>Sleep disturbance severity. Timepoint: Before intervention, at the end of each week, after intervention. Method of measurement: Numeric rating scale (NRS).</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>Ahvaz Jundishapur University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-21</approval_date>
        <contact_name>Ahvaz Jundishapur University of Medical Science</contact_name>
        <contact_address>Research center, Golestan Blv Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
