<?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>IRCT20191224045885N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-12</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of forced air warming and warmed intravenous fluid on comfort and prevention of shivering</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of forced air warming and warmed intravenous fluid on comfort and prevention of shivering after spinal anesthesia in patient undergoing orthopedic surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44580</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Patients were randomly divided into 6 groups and divided into three groups, Blinding description: In this study, all three groups of participants were kept blind. Patients will be told that the study is intended for your well-being so that they will experience comfortable environmental surgery.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients undergoing orthopedic surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first group of serum recipients will be operated at room temperature (21-23 ° C) and hot air at 38 ° C (Warm Touch; Mallinckrodt Medical, St Louis, MO, USA). Intervention 2: Intervention group:  For the second group, 37 ° C warm serum kept in the heater prior to infusion (Fan Azma Gostar.CO, Iran; Thermometer Industrial Group) to reach 37 ° C during infusion. Intervention 3: Control group: The third group is the control group that will be under routine care of serum and room temperature (21-23 ° C).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All potential data can be shared after unidentifiable people.

When:
Start access period 7 months after publishing results.

To whom:
The data will be available to researchers working in academic and scientific institutions

Conditions:
Compliance with the rules is not a restriction on the use of data.

Where to obtain:
Kashan University of Medical Sciences-Tel: 03155540021 Email: info@kaums.ac.ir

How to obtain:
Access period starting from September 1999 through Kashan University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Moheb Mehdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bustan Blvd</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8719334801</zip>
        <telephone>+98 31 5543 4556</telephone>
        <email>mehdi.moheb8445@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rezai Mahboubeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rajai Street</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973474</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>m4.rezaei@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having orthopedic surgery in the lower limb and under spinal anesthesia
Having the consent to participate in the study
Patients who are in Class 1 and 2 according to the American Anesthesiological Association (ASA)
Patients 18-60 years old
No corticosteroid drugs and NSAIDs taken 24 hours before surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Blood injection and blood products during surgery
Conversion of spinal anesthesia to general anesthesia during surgery due to insufficient surface area and severity of anesthesia
The temperature of the tympanic membrane is less than 36.5 and greater than 37.5 ° C
Increased spinal anesthesia
Duration of surgery more than 3 hours</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>Intervention group: The first group of serum recipients will be operated at room temperature (21-23 ° C) and hot air at 38 ° C (Warm Touch; Mallinckrodt Medical, St Louis, MO, USA).</i_keyword>
      <i_keyword>Intervention group:  For the second group, 37 ° C warm serum kept in the heater prior to infusion (Fan Azma Gostar.CO, Iran; Thermometer Industrial Group) to reach 37 ° C during infusion.</i_keyword>
      <i_keyword>Control group: The third group is the control group that will be under routine care of serum and room temperature (21-23 ° C).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patients' shivering based on quadratic scale: No shiver 0; Mild shiver: Mild contractions in facial and neck muscles (1); Moderate shiver: Apparent shivering in neck and shoulders and extremities (2); Severe shivering: Apparent shivering They will be evaluated throughout the body (3). Timepoint: On arrival before spinal (0 minutes), 15 minutes after spinal, surgical completion time, recovery time, and 15 minutes after surgery. Method of measurement: Quadruple shivering Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patients' comfort ratings will be scored based on a VAS observation score ranging from 0 to 10. (0 indicates patient satisfaction with temperature and temperature; and 10 indicates worst patient perception of temperature and temperature conditions  ). Timepoint: On arrival before spinal (0 minutes), 15 minutes after spinal, surgical completion time, recovery time, and 15 minutes after surgery. Method of measurement: Visual Analogue Scale.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-30</approval_date>
        <contact_name>Ethics Committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>15 Khordad Square, Municipality street Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
