<?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>IRCT2014101719561N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-03-17</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness using of TENS (Transcutaneous Electrical Nerve Stimulation) in pain controlling while change dressing in hospitalized burned patients</public_title>
      <acronym>TENS(Transcutaneous Electrical Nerve Stimulation)</acronym>
      <scientific_title>Effectiveness using of TENS (Transcutaneous Electrical Nerve Stimulation) in pain controlling while change dressing in hospitalized burned patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17484</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>burn.</hc_freetext>
      <i_freetext>Intervention 1: Control Group: Before washing the patient’s lesions and exchanging the bandage, 5 mg of Morphine ampoule is infusion and we start to exchange the bandage 15 minutes later and at the last, the Patient’s pain level is asked and recorded from the patient on the base of 0-10 pain numerical scale. Intervention 2: Intervention Group: Before washing the patient’s wounds and exchanging the dress, infusion Morphine ampoule for 5 mg and we start to exchange the bandage 15 minutes later. Morphine ampoule was infusion before exchanging the dress and then, leads of TENS device were connected to Distal of burned organ and later, we turn on the device and 60-100 HZ frequency rate and 10-30 mA amperage are given and then, we begin to washing and exchanging the bandage and again the patient’s pain level during the dress exchange is asked and recorded at the end. Intervention 3: Placebo Group: Before washing the patient’s wounds and exchanging the dress, 5 mg of Morphine ampoule is infusion and we start to exchange the dress 15 minutes later. Morphine ampoule was infusion before exchange the dress and then, leads of Tens device were connected to Distal of burned organ and later, we turn on the TENS device but no frequency is given and then, we begin to washing and exchanging the dress and again the patient’s pain level during the dress exchange is asked and recorded at the end.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mahtab Khajeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vasee hospital</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613984154</zip>
        <telephone>+98 51 4423 9605</telephone>
        <email>mahtabkhajeh@yahoo.com</email>
        <affiliation>Sabzevar University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Savoshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vasee hospital- part burn</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613846776</zip>
        <telephone>+98 514465130010</telephone>
        <email>siavoshi_mohammad@yahoo.comma.mohammad91@gmail.comsiavoshi.m1@medsab.ac.ir</email>
        <affiliation>Sabzevar University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: All of patients with Superficial and deep by grade 2 of burn; The consciousness burned patients to 4-20 range percent; The patients that have 15-70 age old; The burned patients in upper or lower or upper and lower members. Exclusion criteria: The mental retardation patients that don’t talk measure of numeric pain scale; The burned patients less of 4 and more of 20 percent; The pregnant patients (special in third of pregnancy); The patients with heart disorders or have a pace maker; The patients with sensibility to gel; The patients that have an epilepsy.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T30.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burn of second degree, body region unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control Group: Before washing the patient’s lesions and exchanging the bandage, 5 mg of Morphine ampoule is infusion and we start to exchange the bandage 15 minutes later and at the last, the Patient’s pain level is asked and recorded from the patient on the base of 0-10 pain numerical scale.</i_keyword>
      <i_keyword>Intervention Group: Before washing the patient’s wounds and exchanging the dress, infusion Morphine ampoule for 5 mg and we start to exchange the bandage 15 minutes later. Morphine ampoule was infusion before exchanging the dress and then, leads of TENS device were connected to Distal of burned organ and later, we turn on the device and 60-100 HZ frequency rate and 10-30 mA amperage are given and then, we begin to washing and exchanging the bandage and again the patient’s pain level during the dress exchange is asked and recorded at the end.</i_keyword>
      <i_keyword>Placebo Group: Before washing the patient’s wounds and exchanging the dress, 5 mg of Morphine ampoule is infusion and we start to exchange the dress 15 minutes later. Morphine ampoule was infusion before exchange the dress and then, leads of Tens device were connected to Distal of burned organ and later, we turn on the TENS device but no frequency is given and then, we begin to washing and exchanging the dress and again the patient’s pain level during the dress exchange is asked and recorded at the end.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: while intervention(in third days of hospitalization). Method of measurement: measure of numeric pain scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Skin sensivity to TENS. Timepoint: after of end intervention. Method of measurement: observation.</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>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-12</approval_date>
        <contact_name>Sabzevar University of Medical Science</contact_name>
        <contact_address>Tehran road-side the road police-Sabzevar University of Medical Science Sabzevar  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
