<?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>IRCT20210301050536N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-15</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of using short message information system on the level of anxiety and awareness of patient companions during surgery and wound care after surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of using short message information system [Application Programing Interface (API)] on the level of anxiety and awareness of patient companions during surgery and wound care after surgery of patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54698</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Blinding description: Participants do not know which experimental and control groups they belong to, and are only informed of the intervention for themselves.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety and awareness of patient companions during surgery and wound care after surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The families of patients in the intervention group receive six messages about the progress of the surgery and the patient's condition as follows during the waiting period during surgery from the time of admission in the operating room to the time of transfer of the patient to recovery. 1- Greetings and welcome, your patient was admitted to the operating room and is waiting to enter the operating room. 2- In the name of God, the surgery of your patient started with general anesthesia / regional anesthesia and the approximate duration of the surgery. . . Minutes. 3- The progress of the surgery is going well and the patient is in a good condition. 4- Your patient's surgery is coming to an end and the patient's general condition is favorable. 5- Your patient's operation was completed with God's help and the patient is ready to be transferred to recovery after a few minutes. 6- Your patient was transferred to recovery and after about. . . The minute is transferred to the relevant section. At the end of the surgery, a link containing the information of surgical wound care and knowledge related to Covid-19 disease will be sent to the mobile phones of the patients of the experimental group through the SMS system. This system (https://salamathamyar.ir) has been prepared by a computer engineer majoring in artificial intelligence and has been purchased for use in our study. The design of this system was ordered in such a way that it is possible to send a message or image of the wound by patients' families if there are any concerns or questions about surgical wound care, and by sending a message to the doctor to check his patient's condition, Be informed and can answer the question in this system. After the doctor responds, they are notified of the doctor's response by sending a message to the patient's family's mobile phone. Intervention 2: Control group: Companions of patients in the comparison group only have information that they routinely receive.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is It is not allowed to publish equal to the code of ethics</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahim Nasiri Formi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Traditional and Complementary Medicine Research Center of Mazandaran University of Medical Sciences, Payambar Azam University Complex, 17 km of Farahabad Road, Farahabad Road, Khazar Square</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4847116548</zip>
        <telephone>+98 11 3354 2469</telephone>
        <email>enasiri@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahim Nasiri Formi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Traditional and Complementary Medicine Research Center of Mazandaran University of Medical Sciences, Payambar Azam University Complex, 17 km of Farahabad Road, Farahabad Road, Khazar Square</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4847116548</zip>
        <telephone>+98 11 3354 2469</telephone>
        <email>enasiri@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Companions of ASA1 and ASA2 patients
First-degree family members include fathers, mothers, spouses, children, siblings of patients undergoing surgery
The duration of surgery is at least one hour</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient or a member of the patient's family should be part of the treatment staff
Surgery of high-risk patients</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The families of patients in the intervention group receive six messages about the progress of the surgery and the patient's condition as follows during the waiting period during surgery from the time of admission in the operating room to the time of transfer of the patient to recovery. 1- Greetings and welcome, your patient was admitted to the operating room and is waiting to enter the operating room. 2- In the name of God, the surgery of your patient started with general anesthesia / regional anesthesia and the approximate duration of the surgery. . . Minutes. 3- The progress of the surgery is going well and the patient is in a good condition. 4- Your patient's surgery is coming to an end and the patient's general condition is favorable. 5- Your patient's operation was completed with God's help and the patient is ready to be transferred to recovery after a few minutes. 6- Your patient was transferred to recovery and after about. . . The minute is transferred to the relevant section. At the end of the surgery, a link containing the information of surgical wound care and knowledge related to Covid-19 disease will be sent to the mobile phones of the patients of the experimental group through the SMS system. This system (https://salamathamyar.ir) has been prepared by a computer engineer majoring in artificial intelligence and has been purchased for use in our study. The design of this system was ordered in such a way that it is possible to send a message or image of the wound by patients' families if there are any concerns or questions about surgical wound care, and by sending a message to the doctor to check his patient's condition, Be informed and can answer the question in this system. After the doctor responds, they are notified of the doctor's response by sending a message to the patient's family's mobile phone.</i_keyword>
      <i_keyword>Control group: Companions of patients in the comparison group only have information that they routinely receive.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety level. Timepoint: The first stage is the time of admission of the patient in the operating room and the second stage is in the final stages of the surgery. Method of measurement: Spielberger overt and covert anxiety questionnaire.</prim_outcome>
      <prim_outcome>Awareness level. Timepoint: The first stage is the time of admission of the patient in the operating room and the second stage is the time of discharge from the operating room. Method of measurement: Researcher-made Questionnaire Awareness of Wound Care and Covid-19.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Discharge from the wound. Timepoint: Time to remove surgical wound sutures. Method of measurement: Complete the wound healing checklist as observed.</sec_outcome>
      <sec_outcome>Bleeding from the wound. Timepoint: Time to remove surgical wound sutures. Method of measurement: Complete the wound healing checklist as observed.</sec_outcome>
      <sec_outcome>Inflammation of the wound. Timepoint: Time to remove surgical wound sutures. Method of measurement: Complete the wound healing checklist as observed.</sec_outcome>
      <sec_outcome>Warm wound. Timepoint: Time to remove surgical wound sutures. Method of measurement: Complete the wound healing checklist as observed.</sec_outcome>
      <sec_outcome>Redness of the wound site. Timepoint: Time to remove surgical wound sutures. Method of measurement: Complete the wound healing checklist as observed.</sec_outcome>
      <sec_outcome>Opening the edges of the wound. Timepoint: Time to remove surgical wound sutures. Method of measurement: Complete the wound healing checklist as observed.</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>2021-02-24</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Moallem Square, Vice Chancellor for Research and Technology, 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>
