<?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>IRCT20220427054677N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-05</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of Aloe Vera compress and warm compress on pain and phlebitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of two methods of Aloe Vera compress and hot compress on pain and degree of intravenous catheter phlebitis in children hospitalized in pediatric wards</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63725</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sampling method is that first the control group is taken (30 pieces) and then for the group of interventions we act according to the method of random allocation law in such a way that 60 color cards (30 pieces of blue color card for the intervention group and 30 pieces) Put the red color card for the intervention group (warm compress) in a box and based on the exit of the color cards by the mother of the eligible sick child, it will be placed in the intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Children with phlebitis and pain from a venous catheter.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In this group, the researcher first wears disposable gloves and impregnates a sterile gauze with 5 cc of aloe vera gel (brand Kaman of Ceylan Sabz Company) which has been drawn with a syringe, and then on the place of the child's phlebitis. And then cover the area with a bandage for 20 minutes. This intervention will be repeated every 12 hours to 3 days (at 0,12, 24, 36, 48, 60, 72 hours after the intervention). Intervention 2: Intervention group 2: In this group, first the heat jelly pack (model 810 or Sina Hakim, size 8 * 10) will be placed in the microwave for 20-60 seconds, and then the pack will be gently pushed out by a gas. The temperature will be checked with a digital thermometer, the temperature of which is 37-38 degrees Celsius, then the pack will be covered with sterile gas and placed on the phlebite for 20 minutes. This intervention will be repeated every 12 hours to 3 days (at 0,12, 24, 36, 48, 60, 72 hours after the intervention). Intervention 3: Control group: no intervention will be performed and like the other two groups (in the time of 0, 24, 48, 72 hours) the degree of phlebitis and pain score will be recorded in them.</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 Informed consent obtained from patients is only for the use of their information in this study, so they may not be satisfied for other people to access their information even if not identified.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Foruzan Hajiabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical Sciences Campus, Dr. Hesabi Square, zahedan</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3337 2151</telephone>
        <email>rezvanhajiabadi16@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Foruzan Hajiabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medical Sciences Campus, Dr. Hesabi Square, zahedan</address>
        <city>zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3337 2151</telephone>
        <email>rezvanhajiabadi16@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Lack of underlying diseases such as diabetes, asthma and skin diseases
Having an antibiotic regimen other than vancomycin
No allergic reaction to aloe vera compress and hot compress
Age 3-8 years
Has the necessary awareness and ability to participate in research
Having phlebitis due to venous catheter from grade 1-5
Parental written consent
Not too much pain and unbearable due to phlebitis</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>8 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Discharge from hospital three days before the start of the study
Reluctance to continue collaborating in the study
Lack of proper and timely use of aloe vera compress or hot compress during the study
Illness for any reason
Exacerbation of phlebitis symptoms and pain in the patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>180</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Phlebitis and thrombophlebitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: In this group, the researcher first wears disposable gloves and impregnates a sterile gauze with 5 cc of aloe vera gel (brand Kaman of Ceylan Sabz Company) which has been drawn with a syringe, and then on the place of the child's phlebitis. And then cover the area with a bandage for 20 minutes. This intervention will be repeated every 12 hours to 3 days (at 0,12, 24, 36, 48, 60, 72 hours after the intervention).</i_keyword>
      <i_keyword>Intervention group 2: In this group, first the heat jelly pack (model 810 or Sina Hakim, size 8 * 10) will be placed in the microwave for 20-60 seconds, and then the pack will be gently pushed out by a gas. The temperature will be checked with a digital thermometer, the temperature of which is 37-38 degrees Celsius, then the pack will be covered with sterile gas and placed on the phlebite for 20 minutes. This intervention will be repeated every 12 hours to 3 days (at 0,12, 24, 36, 48, 60, 72 hours after the intervention).</i_keyword>
      <i_keyword>Control group: no intervention will be performed and like the other two groups (in the time of 0, 24, 48, 72 hours) the degree of phlebitis and pain score will be recorded in them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The degree of change in the degree of phlebitis compared to before the study. Timepoint: 24 hours and 48 hours and 72 hours after the start of the intervention. Method of measurement: Iranian Nursing Association Phlebitis Degree Observation Checklist.</prim_outcome>
      <prim_outcome>The degree of change in pain score compared to before the study. Timepoint: 24 hours and 48 hours and 72 hours after the start of the intervention. Method of measurement: "Wong Baker" Pain Image Scale.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-09</approval_date>
        <contact_name>Sistan and Baluchestan University of Medical Sciences and Health Services</contact_name>
        <contact_address>Medical Sciences Campus, Dr. Hesabi Square, zahedan zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
