<?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>IRCT20200726048208N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-05</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Nursing Recommendation of National Pressure Ulcer Advisory Panel on Prevention of Medical device–related pressure injury in Intensive Care Unit of Qazvin velayat Hospital</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Nursing Recommendation of National Pressure Ulcer Advisory Panel on Prevention of Medical device–related pressure injury in Intensive Care Unit of Qazvin velayat Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49859</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Compression injury caused by medical device.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The second phase of astrology is performed one week after the first phase and in the same section in the intervention group. At this stage, 60 patients who meet the inclusion criteria will be examined. For this purpose, a checklist of demographic characteristics is completed for each patient and then a checklist of medical equipment will be completed and the type of equipment will be specified. The intervention will be implemented in accordance with the recommendation that this nursing recommendation of the International Association of Acute Wounds in the prevention of compression injuries caused by medical equipment includes seven clauses, which include: 1) choosing the appropriate size of medical equipment appropriate to the person, 2) use Preventive dressings in high-risk areas, 3) Evaluate the skin area in contact with medical equipment, 4) Avoid placing equipment At the site of previous injuries, 5) Inform skin edema under medical equipment, 6) Educate staff on the proper use of medical equipment and injury prevention, and 7) Avoid contact of objects and equipment left in bed and chairs with patient skin. is. For ease of implementation, the nursing referral letter will be planned and implemented in three steps. These steps include 1) staff training, 2) comprehensive skin monitoring, and 3) preventative dressing. The first step is to train the staff. In this regard, immediately after the sampling of the comparison group, the researcher conducted a two-hour training session for the nurses of the ICU of the provincial hospital in the field of prevention of pressure injury caused by medical equipment in PowerPoint format. Will provide this if they need more trainingIt was possible that this training will be done in the ICU itself according to the conditions of the patients in the ICU ward where it is not possible for all staff to leave the ward. Ways to prevent this type of injury are in line with the International Wound Association Nursing Recommendation. In order to perform the comprehensive skin monitoring step, the researcher will monitor the skin and equipment three times in 21 days in accordance with checklist number two, and in the preventive dressing step, the researcher will perform preventive dressing three times a day for 21 days. The pad will be used at the point of contact of the equipment with the patient's skin. Throughout the intervention, the assessment according to checklist number one by the researcher continues for 21 days or until the patient suffers from pressure injury caused by medical equipment (the study range is from 24 hours to 21 days). In the event of compressive injury, a calibration tool is used to determine the severity of the injury. Intervention 2: Control group: The first phase of the study will be conducted in a comparison group. At this stage, 60 patients with inclusion criteria (based on the number obtained from the sample size formula) will be examined. For this purpose, a demographic profile checklist is completed for each patient, and then a medical equipment checklist will be completed and the type of equipment will be specified (checklist number one). This examination begins when the patient is connected to the equipment and the daily assessment is performed by the researcher in the morning shift for 21 days (47) or until the patient suffers from compression injury caused by medical equipment and at any time the pressure injury caused The severity of the injury was determined from the medical equipment based on the wound severity rating instrument (the study range is from 24 hours to 21 days).</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>lida shamekhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Bahonar St.</address>
        <city>qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3413635595</zip>
        <telephone>+98 28 3322 3973</telephone>
        <email>shamekhi1367@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>farnoosh rashvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin University of Medical Sciences, Bahonar St.</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3413635595</zip>
        <telephone>+98 28 3333 6001</telephone>
        <email>n.rashvand@yahoo.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent of the patient or his family to participate in the research.
Have at least one medical device attached to the patient</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Restrictions on examining the skin under the device attached to the patient, for example, examining the skin under the neck in a patient with limited neck movement.
Reluctance to participate in research
If the equipment is removed within the first 24 hours, the patient is transferred to the ward or dies</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The second phase of astrology is performed one week after the first phase and in the same section in the intervention group. At this stage, 60 patients who meet the inclusion criteria will be examined. For this purpose, a checklist of demographic characteristics is completed for each patient and then a checklist of medical equipment will be completed and the type of equipment will be specified. The intervention will be implemented in accordance with the recommendation that this nursing recommendation of the International Association of Acute Wounds in the prevention of compression injuries caused by medical equipment includes seven clauses, which include: 1) choosing the appropriate size of medical equipment appropriate to the person, 2) use Preventive dressings in high-risk areas, 3) Evaluate the skin area in contact with medical equipment, 4) Avoid placing equipment At the site of previous injuries, 5) Inform skin edema under medical equipment, 6) Educate staff on the proper use of medical equipment and injury prevention, and 7) Avoid contact of objects and equipment left in bed and chairs with patient skin. is. For ease of implementation, the nursing referral letter will be planned and implemented in three steps. These steps include 1) staff training, 2) comprehensive skin monitoring, and 3) preventative dressing. The first step is to train the staff. In this regard, immediately after the sampling of the comparison group, the researcher conducted a two-hour training session for the nurses of the ICU of the provincial hospital in the field of prevention of pressure injury caused by medical equipment in PowerPoint format. Will provide this if they need more trainingIt was possible that this training will be done in the ICU itself according to the conditions of the patients in the ICU ward where it is not possible for all staff to leave the ward. Ways to prevent this type of injury are in line with the International Wound Association Nursing Recommendation. In order to perform the comprehensive skin monitoring step, the researcher will monitor the skin and equipment three times in 21 days in accordance with checklist number two, and in the preventive dressing step, the researcher will perform preventive dressing three times a day for 21 days. The pad will be used at the point of contact of the equipment with the patient's skin. Throughout the intervention, the assessment according to checklist number one by the researcher continues for 21 days or until the patient suffers from pressure injury caused by medical equipment (the study range is from 24 hours to 21 days). In the event of compressive injury, a calibration tool is used to determine the severity of the injury</i_keyword>
      <i_keyword>Control group: The first phase of the study will be conducted in a comparison group. At this stage, 60 patients with inclusion criteria (based on the number obtained from the sample size formula) will be examined. For this purpose, a demographic profile checklist is completed for each patient, and then a medical equipment checklist will be completed and the type of equipment will be specified (checklist number one). This examination begins when the patient is connected to the equipment and the daily assessment is performed by the researcher in the morning shift for 21 days (47) or until the patient suffers from compression injury caused by medical equipment and at any time the pressure injury caused The severity of the injury was determined from the medical equipment based on the wound severity rating instrument (the study range is from 24 hours to 21 days).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pressure injury. Timepoint: Interval 24 hours to 21 days. Method of measurement: Scale grading pressure ulcer.</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, Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-06</approval_date>
        <contact_name>Ethics Committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin University of Medical Sciences, Bahonar St. Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
