<?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>IRCT20200304046691N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-09</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of care plan on body temperature and recovery time</public_title>
      <acronym></acronym>
      <scientific_title>Assessment The effect of hypothermia prevention program on shivering, core body temperature and recovery time in patients undergoing abdominal surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46403</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In our study, hypothermia prevention protocol is performed on patients with general anesthesia for abdominal surgery, Randomization description: Permutation block randomization will be used to allocate participants randomly،So that 80 envelopes are made and each envelope is labeled as A or B. When the first patient meets the inclusion criteria, the first envelope is opened and given the name of the group, if A was in the intervention group and if B was in the control group, the same would be done until the last sample. Comments will be made, Blinding description: The sampling conditions are randomized so that the patient is not aware of the measures to be taken, but since the parameters are measured by the researcher, the blinding researcher does not. The permutation block randomization method will be used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Patients undergoing abdominal surgery Like cholecystectomy. Condition 2: Patients undergoing abdominal surgery Like abdominal hernias. Condition 3: Patients undergoing abdominal surgery Like a hysterectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This clinical trial study will be performed on 80 candidates undergoing abdominal surgery by general anesthesia referring to the operating room of teaching hospitals of Zahedan University of Medical Sciences. Given the random allocation,  40 patients in the intervention group, in this group, after being admitted to the operating room on the surgical bed, received anesthesia induction drugs according to the standard protocol (receiving anesthesia would be the same in both groups) and then receiving permission from the team،intervention Under the heading of a hypothermia prevention program, it is performed on patients with entry criteria, which، Anesthetist will scrub and drip using a heated disinfectant up to 32 ° C (by Warmer machine). Infusion of injectable liquids will begin with warm serum of 37 degrees. After surgery, patients are transferred to the recovery bed. This bed and blanket were prepared half an hour before the patient was transferred to recovery by two to three 40-by-60-cm warm water bags pre-heated with standard anesthetic (Fig. 1) so after placement The patient will be warm on the bed Both the bed and the blanket on the patient will be followed by two smaller warm water bags in the axillary and thigh area of ​​the patient.In both groups, data will be collected on the basis of data collection forms, including personal information and information on surgery and anesthesia, as well as recording of central temperature, blood pressure, pulse and arterial oxygen saturation, chills. And it will be a recovery time. Seven times will be measured: 5 minutes before anesthesia, 5 minutes after induction of anesthesia, 30 minutes after surgery, after surgery,On arrival to recovery, 0.5 hours and 1 hour after transfer. The patient will be monitored for recovery. Intervention 2: Control group: 40 patients in the control group received routine, routine operating room care, including perforation, drip, and infusion of operating room temperature fluid, and will be transferred to recovery beds after surgery. They will be covered with routine blankets.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is هنوز تصمیم نگرفته ام که داده هایم را دراختیار بگذارم یا نه</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh Azarmehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghadir Shahr, 18 Meters From Al-Zahra, The Intersection of The Martyr Lekzai and The Flower of Maryam</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9818921847</zip>
        <telephone>+98 54 3269 4179</telephone>
        <email>t.azarmehr74@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Houshang Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sari, Jouybar Three-way, At the beginning of Valiasr Highway, Headquarters of Mazandaran University of Medical Sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815733971</zip>
        <telephone>+98 11 3304 4000</telephone>
        <email>Hooshangakbari48@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing elective abdominal surgery including abdominal hernia and open hysterectomy and open cystectomy
Patients receiving general anesthesia
ASA class 1 and 2 patients
Surgical incisions above 5 cm
Surgery time of at least one hour and maximum of 2.5 hours</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Occurrence of any condition affecting the patient's normal anesthesia and surgery, such as excessive bleeding and cardiac arrest during surgery
Having underlying diseases (thyroid, diabetes, cardiovascular disease and chronic hypertension)
Receiving blood and blood products during surgery
Intravenous fluids greater than 5 liters during surgery, temperatures above 37.5 ° C or less than 36.5 ° C before surgery
Significant hypotension during surgery (20% blood pressure lower than before anesthesia)
Endocrine Disorders
Corticosteroid intake
Non-steroidal analgesic and magnesium sulfate
Fever, and addiction
Prohibition on controlling body temperature through the tympanic membrane
Lack of patient satisfaction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K91.86</hc_code>
      <hc_code>K43.2</hc_code>
      <hc_code>N99.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Retained cholelithiasis following cholecystectomy</hc_keyword>
      <hc_keyword>Incisional hernia without obstruction or gangrene</hc_keyword>
      <hc_keyword>Prolapse of vaginal vault after hysterectomy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This clinical trial study will be performed on 80 candidates undergoing abdominal surgery by general anesthesia referring to the operating room of teaching hospitals of Zahedan University of Medical Sciences. Given the random allocation,  40 patients in the intervention group, in this group, after being admitted to the operating room on the surgical bed, received anesthesia induction drugs according to the standard protocol (receiving anesthesia would be the same in both groups) and then receiving permission from the team،intervention Under the heading of a hypothermia prevention program, it is performed on patients with entry criteria, which، Anesthetist will scrub and drip using a heated disinfectant up to 32 ° C (by Warmer machine). Infusion of injectable liquids will begin with warm serum of 37 degrees. After surgery, patients are transferred to the recovery bed. This bed and blanket were prepared half an hour before the patient was transferred to recovery by two to three 40-by-60-cm warm water bags pre-heated with standard anesthetic (Fig. 1) so after placement The patient will be warm on the bed Both the bed and the blanket on the patient will be followed by two smaller warm water bags in the axillary and thigh area of ​​the patient.In both groups, data will be collected on the basis of data collection forms, including personal information and information on surgery and anesthesia, as well as recording of central temperature, blood pressure, pulse and arterial oxygen saturation, chills. And it will be a recovery time. Seven times will be measured: 5 minutes before anesthesia, 5 minutes after induction of anesthesia, 30 minutes after surgery, after surgery,On arrival to recovery, 0.5 hours and 1 hour after transfer. The patient will be monitored for recovery</i_keyword>
      <i_keyword>Control group: 40 patients in the control group received routine, routine operating room care, including perforation, drip, and infusion of operating room temperature fluid, and will be transferred to recovery beds after surgery. They will be covered with routine blankets.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Central body temperature. Timepoint: Before Intervention - During Intervention - After Intervention. Method of measurement: Based on the temperature and using a tympan thermometer.</prim_outcome>
      <prim_outcome>Shiver. Timepoint: During the intervention - after the intervention. Method of measurement: Will be reviewed according to the Crossley classification. Grade 1 = no shiver, grade 2 = slight shivering (straightening of hair, peripheral cyanosis without visible shake), grade 3 = moderate shivering (visible muscle shake in a group of muscles), grade 4 = severe shivering (muscle shake in All body muscles).</prim_outcome>
      <prim_outcome>Recovery time. Timepoint: after surgery. Method of measurement: timer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before intervention - During intervention - After intervention. Method of measurement: Systolic and diastolic blood pressure monitored using a millimeter of mercury.</sec_outcome>
      <sec_outcome>Number of pulses. Timepoint: Before intervention - During intervention - After intervention. Method of measurement: Using the monitor on a per-minute basis.</sec_outcome>
      <sec_outcome>Breath rate. Timepoint: Before intervention - During intervention - After intervention. Method of measurement: Using the monitor on a per-minute basis.</sec_outcome>
      <sec_outcome>Percentage of arterial blood oxygen saturation. Timepoint: Before intervention - During intervention - After intervention. Method of measurement: Using a monitor based on percentages.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-26</approval_date>
        <contact_name>Vice chancellor for research and technology of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Sari, Imam Square, Jouybar Road, Valiasr Highway, Central Headquarters of Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
