<?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>IRCT2015051022192N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-17</date_registration>
      <primary_sponsor>Vice Chancellor for research of Zahedan University of Medical Science</primary_sponsor>
      <public_title>The effect of massage therapy and  cryotherapy on pain and lung volume in patients undergoing open heart surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of massage therapy and cryotherapy on pain and lung volume in patients undergoing coronary artery bypass graft surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19196</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: Single-blind study because of pain and lung volumes were measured by anyone other than researcher.&#13;
Research on Three Card cryotherapy, massage therapy and control written and the box has poured randomly selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>coronary artery bypass graft.</hc_freetext>
      <i_freetext>Intervention 1: The Patients of the massage group: Swedish massage for 20 minutes, 48 hours after surgery with mild to moderate pressure, The Place of the massage depends on the willingness of the patient. Scentless and fragrance from a lubricant (glycerin) was used. Intervention 2: The Patients of cryotherapy group: Frozen Gel packs of 10 x 14 cm with a weight of 175 g , it was put  out of the fridge an hour before the intervention   in a cloth cover  and it was laid on  the sternum dressing  For 20 minutes intermittently  every 5 to 10 minutes. Intervention 3: The patients in the control group: patients received routine care and similar environmental intervention groups were provided for them. The companions of the patient left the room for 20 minutes then   the patient was encouraged to rest in bed.</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>Elham Ali Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Mashaheer Squar</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816913396</zip>
        <telephone>+98 54 3343 3644</telephone>
        <email>"ealiahmadi114@yahoo.com"؛ "aliahmad114aliahmad@gmail.com"</email>
        <affiliation>Zahedan University of Medical Science, School of Nursing &amp; Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Pishkar Mofrad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Mashaheer square</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816913396</zip>
        <telephone>+98 54 3343 8473</telephone>
        <email>"pishkarz@gmail.com"؛ "aliahmad114aliahmad@gmail.com"</email>
        <affiliation>Zahedan University of Medical Science, School of Nursing &amp; Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Based on  previous planning the patient  underwent surgery. (Elective surgery); the  patient age  must be  between 35 to 75 years; Personal medicines  such as hypnotics, benzodiazepines, sedatives, drugs and alcohol    must not  be used ; The  minimum pain score  by visual scale of pain before intervention was  40;  The history of diabetes  was less than 5 years; Thorax surgery is the first  patient's  experience; The type of graft  used for patient was  saphenous vein or left mammary artery;  the patient  does not  suffer from chronic respiratory disease; Cardiac output was  more than 40% based on echocardiography performed before surgery. Exclusion criteria: Patients who had  a lot of pain and did not   want to be touched   or to  continue;   The placement  of Chest tube was   at the time of data collection;  Suffering  from  post-operative complications such as infection, bleeding, open wound  (wound dehiscence) or uncontrolled dysrhythmia; severe emotional stress during the study; Patients who have received  sedatives other than the routine  sedatives or the use of analgesics  was  less than 4 hours before the intervention.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>151.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>atherosclerotic cardiovascular disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The Patients of the massage group: Swedish massage for 20 minutes, 48 hours after surgery with mild to moderate pressure, The Place of the massage depends on the willingness of the patient. Scentless and fragrance from a lubricant (glycerin) was used.</i_keyword>
      <i_keyword>The Patients of cryotherapy group: Frozen Gel packs of 10 x 14 cm with a weight of 175 g , it was put  out of the fridge an hour before the intervention   in a cloth cover  and it was laid on  the sternum dressing  For 20 minutes intermittently  every 5 to 10 minutes.</i_keyword>
      <i_keyword>The patients in the control group: patients received routine care and similar environmental intervention groups were provided for them. The companions of the patient left the room for 20 minutes then   the patient was encouraged to rest in bed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: 10 to 15 minutes before and 10 to 15 minutes after intervention. Method of measurement: In order to determine the severity of pain visual analog scale was used.</prim_outcome>
      <prim_outcome>Lung volumes. Timepoint: 10 to 15 minutes before and 10 to 15 minutes after intervention. Method of measurement: Model spirometer Spiro lab III, Tuk - MIR009, ITALY.</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>Vice Chancellor for research of Zahedan University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-31</approval_date>
        <contact_name>Ethics committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Pardis Zahedan Univercity Of Medical Science, Doctor Hesabi Square Zahedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
