<?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>IRCT201101095578N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-10-05</date_registration>
      <primary_sponsor>Vice-Chancellor for Research, Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of changes in patients' body positions on the back pain and hemodynamics</public_title>
      <acronym></acronym>
      <scientific_title>The effect of continuity of change  positioning  during and after cardiac radiofrequency ablation on patients' back pain and hemodynamic status</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5998</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>Condition 1: patients that have cardiac arrhythmia. Condition 2: prolonged bedrest.</hc_freetext>
      <i_freetext>Intervention 1: Patients in the control group received routine care including lying on their back for 6-8 hours (including duration of the procedure) with no change in their position. Intervention 2: Patients in intervention  group A did lie on their back during the procedure with the head of their bed tilted up for 15 degree, using a small mattress (3×50×80 cm) under their body and their knee bent for 30 degrees using a small cylindrical pillow. In the first and second hours after the procedure, the continued lying on their back with the head of the bed tilted up for 30 and 45 degrees, respectively. During the two hours post procedure, a small pillow was placed alternatively every 30 minutes under right and left side of the body from shoulder to gluteal. Moreover, they continued to use the small cylindrical pillow under their knees. During the third hour, head of the bed was tilted up 30 degrees and the patients did lie on right and left side for 30 minutes each. Within the forth hour, the patients lied on their side (right or left) for 30 minutes with the head of the bed tilted up for 15 degrees followed by sitting for the next 30 minutes. Intervention 3: In case group B, the samples were positioned precisely like patients in group A during the procedure, and they were in the routine position after the procedure (without any alteration). The intensity of the back pain, blood pressure, heart rate, the amount of bleeding and hematoma were measured right after the patients entered the CCU and 2, 4, 6 and 24 hours after ablation in 3 groups.</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>Parisa Mansoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh (P.B.U.H) School of Nursing &amp; Midwifery, Zand St, Namazi square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1647 4254</telephone>
        <email>mansoorip@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hosein Nikoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zand  St, Medical College</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1235 1087</telephone>
        <email>mhnmp@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: eligibility for treatment by radiofrequency catheter ablation; a systolic blood pressure less than 190 mmHg, a diastolic blood pressure less than 110 mmHg. Exclusion criteria were spinal cord disorders; inter-vertebral disk disorders, bleeding disorders; the use of anti-coagulant and analgesic drugs 24 hours prior to the procedure; advanced heart failure, a procedure duration less than one and half   and longer than three and half hours; vast bleeding or any other disorders during the procedure; severe decrease of consciousness level; performing ablation procedure through artery; and tranquilizers use during the procedure.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I49.9</hc_code>
      <hc_code>R26.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cardiac arrhythmia, unspecified</hc_keyword>
      <hc_keyword>Immobility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients in the control group received routine care including lying on their back for 6-8 hours (including duration of the procedure) with no change in their position.</i_keyword>
      <i_keyword>Patients in intervention  group A did lie on their back during the procedure with the head of their bed tilted up for 15 degree, using a small mattress (3×50×80 cm) under their body and their knee bent for 30 degrees using a small cylindrical pillow. In the first and second hours after the procedure, the continued lying on their back with the head of the bed tilted up for 30 and 45 degrees, respectively. During the two hours post procedure, a small pillow was placed alternatively every 30 minutes under right and left side of the body from shoulder to gluteal. Moreover, they continued to use the small cylindrical pillow under their knees. During the third hour, head of the bed was tilted up 30 degrees and the patients did lie on right and left side for 30 minutes each. Within the forth hour, the patients lied on their side (right or left) for 30 minutes with the head of the bed tilted up for 15 degrees followed by sitting for the next 30 minutes.</i_keyword>
      <i_keyword>In case group B, the samples were positioned precisely like patients in group A during the procedure, and they were in the routine position after the procedure (without any alteration). The intensity of the back pain, blood pressure, heart rate, the amount of bleeding and hematoma were measured right after the patients entered the CCU and 2, 4, 6 and 24 hours after ablation in 3 groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: immediatly, 2, 4,6 and 24 hr aftrr intervention. Method of measurement: numeric rating scale( NRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: before, immediatly, 2,4,6 and 24 hr after intervention. Method of measurement: standard mercury sphygmomanometer.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: befor, immediatly, 2,4,6 and 24 hr after intervention. Method of measurement: by hand during 1 minute.</sec_outcome>
      <sec_outcome>Amount of bleeding. Timepoint: immediatly, 2,4,6 and 24 hr after intervention. Method of measurement: two-dimension ruler.</sec_outcome>
      <sec_outcome>Amount of  hematoma. Timepoint: immediatly, 2,4,6 and 24 hr after intervention. Method of measurement: two-dimensional ruler.</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>Vice-Chancellor for Research, Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-02-15</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>Central building of Shiraz University of Medical Sciences, Zand st, Shiraz Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
