<?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>IRCT138807182560N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2009-11-17</date_registration>
      <primary_sponsor>Qom University of Medical Sciences and Health Services,</primary_sponsor>
      <public_title>Comparison of effects of  two positioning  on back pain and comfort after coronary angiography</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effects of  two changing position on severity of back pain, comfort, blood pressre,  bleeding and hematoma after coronary angiography in Valiasre hospital of Qom, 2009</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2305</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>back pain and discomfort after  coronary angiography.</hc_freetext>
      <i_freetext>Intervention 1: Patients in the first (control) group were managed as routine. Intervention 2: The patients in the second group were positioned as follows: in the supine position with the affected leg straight and immobilized and a sand bag on the puncture site for first hour, in the supine position with the affected leg straight and immobilized and head of bed [HOB]15° elevated during the second hour, in the supine position with the affected leg straight and immobilized and HOB 30° elevated during the third hour, in the supine position with the affected leg straight and immobilized and head of bed [HOB]45° elevated during the fourth hour, in the supine position with the affected leg straight and immobilized and head of bed [HOB]30° elevated during the fifth hour, in the supine position with the affected leg straight and immobilized and head of bed [HOB]15° elevated during the sixth hour. After that, the patients were allowed to come out of bed [OOB], to sit on the chair beside the bed for10min and then to walk around and undertake self care activities. In the second group, the sand bag was taken away 1h after the procedure. Intervention 3: The patients in the third group were positioned as follows: in the supine position with the affected leg straight and immobilized and a sand bag on the puncture site for first hour, in the semi right lateral position with the affected leg straight and immobilized during the second hour, in the supine position with the affected leg straight and immobilized during the third hour, in the semi left lateral position with the affected leg straight and immobilized during the second hour, in the supine position with the affected leg straight and immobilized during the fourth hour, in the semi right lateral position with the affected leg straight and immobilized during the fifth hour, in the supine position with the affected leg straight and immobilized during the sixth hour. While the patients in the third group were in semi lateral position, they were given a thin supportive pillow (10cm×40cm×70cm) under one side of their body, either left or right, from the shoulder to the gluteus area. We changed the place of the pillow every 1 hour in the right or the left side of the body. In seventh hour, the patients were allowed to come out of bed [OOB], to sit on the chair beside the bed for10min and then to walk around and undertake self care activities. In the third group, the sand bag was taken away 1h after the procedure.</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>Yeganeh khah, Mohammad Reza</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12, 2 Senobar lane.,  Sepideh Ave., Bahrami st., Saeedi highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1373765613</zip>
        <telephone>+98 21 6630 4368</telephone>
        <email>yeganeh3603@yahoo.com</email>
        <affiliation>Qom University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yeganeh khah, Mohammad Reza</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12, 2 Senobar lane.,  Sepideh Ave., Bahrami st., Saeedi highway</address>
        <city>Tehrah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3173765613</zip>
        <telephone>+98 21 6630 4368</telephone>
        <email>yeganeh3603@yahoo.com</email>
        <affiliation>Qom University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1) Patients' ages between 18-80 years 2) Had undergone a non-emergency 6 French diagnostic angiography via the femoral artery 3) Had complete alert 4) Ability of patient to assess the pain &amp; comfort with visual analogue scale 5) Had no active bleeding disorders 6) Had no chronic lower back pain &#13;
Exclusion criteria: 1) Had active bleeding at catheter insertion site after angiography 2) Development of artery disorders during angiography 3) Had systolic blood pressure greater than 190mmHg or diastolic blood pressure greater than110mmHg 4) Admission to the coronary care unit or intensive care unit 5) CPR during angiography 6) PT higher than 16 Sec 7) Had no pulse in feet 8) Inability of patient to help for changing 9) Had vomiting greater than 4 times during first 6 hours after angiography</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R29.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients in the first (control) group were managed as routine</i_keyword>
      <i_keyword>The patients in the second group were positioned as follows: in the supine position with the affected leg straight and immobilized and a sand bag on the puncture site for first hour, in the supine position with the affected leg straight and immobilized and head of bed [HOB]15° elevated during the second hour, in the supine position with the affected leg straight and immobilized and HOB 30° elevated during the third hour, in the supine position with the affected leg straight and immobilized and head of bed [HOB]45° elevated during the fourth hour, in the supine position with the affected leg straight and immobilized and head of bed [HOB]30° elevated during the fifth hour, in the supine position with the affected leg straight and immobilized and head of bed [HOB]15° elevated during the sixth hour. After that, the patients were allowed to come out of bed [OOB], to sit on the chair beside the bed for10min and then to walk around and undertake self care activities. In the second group, the sand bag was taken away 1h after the procedure.</i_keyword>
      <i_keyword>The patients in the third group were positioned as follows: in the supine position with the affected leg straight and immobilized and a sand bag on the puncture site for first hour, in the semi right lateral position with the affected leg straight and immobilized during the second hour, in the supine position with the affected leg straight and immobilized during the third hour, in the semi left lateral position with the affected leg straight and immobilized during the second hour, in the supine position with the affected leg straight and immobilized during the fourth hour, in the semi right lateral position with the affected leg straight and immobilized during the fifth hour, in the supine position with the affected leg straight and immobilized during the sixth hour. While the patients in the third group were in semi lateral position, they were given a thin supportive pillow (10cm×40cm×70cm) under one side of their body, either left or right, from the shoulder to the gluteus area. We changed the place of the pillow every 1 hour in the right or the left side of the body. In seventh hour, the patients were allowed to come out of bed [OOB], to sit on the chair beside the bed for10min and then to walk around and undertake self care activities. In the third group, the sand bag was taken away 1h after the procedure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduced back pain and promote physical comfort without increasing vascular complications. Timepoint: every 2 hours(three time after coronary angiography) and  next morning at 08:00h. Method of measurement: Visual Analogue pain Scale(VAS), Visual Analogue comfort Scale, ruler.</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>Qom University of Medical Sciences and Health Services,</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2009-04-05</approval_date>
        <contact_name>Qom University of Medical Sciences and Health Services</contact_name>
        <contact_address>Qom University of Medical Sciences and Health Services, Saheli st., Qom., Iran. Qom  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
