<?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>IRCT20200822048476N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-24</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Prevention of bed sores in the intensive care unit</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Effectiveness of Preventive Nursing care Based on Braden Predictive Scale on the Incidence of Pressure Ulcers in Patients Admitted to the Intensive care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50470</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Randomization description: First, the final sample size, which is 72 people, using winpepi11/0 software with block randomization method, 12 blocks of 6 are assigned to the control and test groups, so that in each of the 6 blocks, 3 people are assigned to the test group. And 3 people are assigned to the control group. This software creates random control and test groups. The sampling method of the test and control groups in these blocks is random.
Steps to use the software: Etcetera - select the randomallocation option and then select randomized bahnced and finally successive blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bedsore of patients admitted to the intensive care unit.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, bed sore prevention is based on the Braden scale checklist, which includes subscales (mobility, activity, skin moisture, nutrition, sensory perception). And assist staff during nursing interventions and care. The Braden scale was recorded by the researcher at the beginning of the study, the first 48 hours, the second 48 hours and the third 48 hours. Care and prevention measures include: Nursing interventions in the mobility subscale: 1. Adjusting the patient position change program based on the hourly chart of the patient's position was changed to the designated position every three hours.2. Change position regularly at least every 2 hours 3. Further change position If the inflamed and reddened area does not change color (does not fade) with finger pressure Nursing interventions in the subscale of activity: 1. Helping the patient to maintain activity as much as possible 2. Inactive exercises were performed, especially in the legs. Exercises were performed in the range of motion. Nursing interventions in the skin moisture subscale: 1. Keep the skin clean and dry at all hours 2. Clean and dry the skin after each disposal 3. Use of a thin layer of oxide oxide to protect the patient's skin involuntarily, after washing and drying the perineum, groin and batex area. Provide adequate nutrition and fluids 2. Provide a diet high in protein, protein and minerals 3. Consult a nutritionist to assess nutritional status in a timely manner 4. Control of serum albumin g / dl 5-5-5 Nursing interventions in the subscale of sensory perception: 1. Evaluation of anesthesia in all areas of the body 2. Complete care of areas without sensation- Nursing interventions in the wear subscale: 1. Reducing the level of pressure: Pillow will be used to reduce the pressure in bone ridges. Intervention 2: Control groupIn the control group, nursing care will be performed by the nurse to prevent the occurrence of pressure ulcers. However, no intervention will be performed by the researcher in the control group and only a part of unplanned nursing care is done in the form of a checklist of nursing interventions for the intervention group. For the control group, routine care is performed, which includes: changing the patient 2 hours 2- Keeping the patient's skin clean and dry 3- Using a wavy mattress 4- Examining and direct observation of the nurse in each shift from areas prone to pressure ulcers 5- Feeding patients using ordinary interamyl gavage powder 6- Using a sponge and lukewarm water for the patient's bath. Also for the control group, the researcher will complete and record the Braden scale 4 times, including the beginning of the study and the first 48 hours, the second 48 hours, the third 48 hours for patients.</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 data is potentially shareable after unidentified individuals

When:
Access period starts from 1400

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

Conditions:
Using the data to carry out other projects in the field of preventive and curative care

Where to obtain:
1- marjannaseri33@gmail.com
2- 09385828712 number

How to obtain:
Earn a request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Asadi Zakir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Khuzestan province, Ahvaz, Medical Sciences Boulevard, Golestan, Jundishapur University of Medical Sciences</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6373174715</zip>
        <telephone>+98 71 4224 9</telephone>
        <email>marziyehasadizakerm@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Asadi Zakir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Khuzestan province, Ahvaz, Medical Sciences Boulevard, Golestan, Jundishapur University of Medical Sciences</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6373174715</zip>
        <telephone>+98 61 3373 8283</telephone>
        <email>marziyehasadizakerm@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 Years
BeingHospitalized in the Intensive Care Unit
Complete Immobility Due to Various Therapeutic Causes
Lack of Evidence of Bed Sores At the Beginning of Hospitalization In the Ward
No Underlying Skinn D iseases
Earn a Score of 14 or Less on the Braden Scale
No infection Underlying Diseases: Diabetes, Cerebrovascular Disorders, Cardiopulmonary Failure, Peripheral Vascular Disease and Peripheral Edema</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Smoking during the last month</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pressure ulcer</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, bed sore prevention is based on the Braden scale checklist, which includes subscales (mobility, activity, skin moisture, nutrition, sensory perception). And assist staff during nursing interventions and care. The Braden scale was recorded by the researcher at the beginning of the study, the first 48 hours, the second 48 hours and the third 48 hours. Care and prevention measures include: Nursing interventions in the mobility subscale: 1. Adjusting the patient position change program based on the hourly chart of the patient's position was changed to the designated position every three hours.2. Change position regularly at least every 2 hours 3. Further change position If the inflamed and reddened area does not change color (does not fade) with finger pressure Nursing interventions in the subscale of activity: 1. Helping the patient to maintain activity as much as possible 2. Inactive exercises were performed, especially in the legs. Exercises were performed in the range of motion. Nursing interventions in the skin moisture subscale: 1. Keep the skin clean and dry at all hours 2. Clean and dry the skin after each disposal 3. Use of a thin layer of oxide oxide to protect the patient's skin involuntarily, after washing and drying the perineum, groin and batex area. Provide adequate nutrition and fluids 2. Provide a diet high in protein, protein and minerals 3. Consult a nutritionist to assess nutritional status in a timely manner 4. Control of serum albumin g / dl 5-5-5 Nursing interventions in the subscale of sensory perception: 1. Evaluation of anesthesia in all areas of the body 2. Complete care of areas without sensation- Nursing interventions in the wear subscale: 1. Reducing the level of pressure: Pillow will be used to reduce the pressure in bone ridges</i_keyword>
      <i_keyword>Control groupIn the control group, nursing care will be performed by the nurse to prevent the occurrence of pressure ulcers. However, no intervention will be performed by the researcher in the control group and only a part of unplanned nursing care is done in the form of a checklist of nursing interventions for the intervention group. For the control group, routine care is performed, which includes: changing the patient 2 hours 2- Keeping the patient's skin clean and dry 3- Using a wavy mattress 4- Examining and direct observation of the nurse in each shift from areas prone to pressure ulcers 5- Feeding patients using ordinary interamyl gavage powder 6- Using a sponge and lukewarm water for the patient's bath. Also for the control group, the researcher will complete and record the Braden scale 4 times, including the beginning of the study and the first 48 hours, the second 48 hours, the third 48 hours for patients</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bedsore. Timepoint: The first 48 hours, the second 48 hours and the third 48 hours. Method of measurement: Braden scale-posh scaling.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-18</approval_date>
        <contact_name>Ethics Committee of Ahwaz University of Medical Sciences</contact_name>
        <contact_address>no.4 west golestan,asfand town Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
