<?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>IRCT2016100830214N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-11-11</date_registration>
      <primary_sponsor>Research Vice President of Urmia University of Medical Sciences</primary_sponsor>
      <public_title>Effect of hypnotherapy on background pain and pain anxiety of men with burn injuries hospitalized in burn ward</public_title>
      <acronym></acronym>
      <scientific_title>Effect of hypnotherapy on intensity and quality of  background pain and pain anxiety of men with second and third degree burn injuries: A blinded, randomized clinical trial with control group</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24082</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Burn of second degree. Condition 2: Burn of third degree.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In this group four sessions of hypnosis will be done. Needed time for hypnosis sessions will range from 15 minutes to one hour depending on the hypnotizability. Different induction techniques would be utilized depending on the age and personal traits. In induction phase of hypnosis some techniques such as eye fixation, progressive muscle relaxation and hand levitation will be used. Imagination, reverse counting, dissociation and progressive muscle relaxation are among the techniques which will be used for deepening of the trance. Non therapeutic and unspecified suggestions will be utilized in this group as placebo control. All sessions will be done between 16 and 20 PM that patients are not tiered. An appropriate room with suitable light and temperature will be chosen for hypnosis sessions. Intervention 2: Intervention group: In this group four sessions of hypnosis will be done. Needed time for hypnosis sessions will range from 15 minutes to one hour depending on the hypnotizability. Different induction techniques would be utilized depending on the age and personal traits. In induction phase of hypnosis some techniques such as eye fixation, progressive muscle relaxation and hand levitation will be used. Imagination, reverse counting, dissociation and progressive muscle relaxation are among the techniques which will be used for deepening of the trance. Therapeutic suggestions will be utilized for disappearing the pain and anxiety. All sessions will be done between 16 and 20 PM that patients are not tiered. An appropriate room with suitable light and temperature will be chosen for hypnosis sessions.</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>Hossein Jafarizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Nazloo highway,Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 44 3193 7224</telephone>
        <email>JAFARIZADEH@UMSU.AC.IR</email>
        <affiliation>Urmia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Jafarizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Nazloo highway,Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 44 3193 7224</telephone>
        <email>JAFARIZADEH@UMSU.AC.IR</email>
        <affiliation>Urmia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients should have diagnosis of burn injury and be hospitalized in hospital; men who are between 18 and 50 years old; passing the emergency phase of burn and being in later phases; second and third degree burn injuries with total body surface area ranging from 5 to 40 percent; Farsi and Azeri speakers; having no problem in hearing and vision; having no diagnosis of psychosis, epilepsy, drug abuse or mental problems; having no history of hypertension or diabetes.&#13;
Exclusion criteria: unwillingness of participation in research; leaving the ward for any reason such as transferring to other hospitals or intensive care unit; discharge or death; wound infection with positive culture; having any out of routine procedure.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T30.2</hc_code>
      <hc_code>T30.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burn of second degree, body region unspecified</hc_keyword>
      <hc_keyword>Burn of third degree, body region unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In this group four sessions of hypnosis will be done. Needed time for hypnosis sessions will range from 15 minutes to one hour depending on the hypnotizability. Different induction techniques would be utilized depending on the age and personal traits. In induction phase of hypnosis some techniques such as eye fixation, progressive muscle relaxation and hand levitation will be used. Imagination, reverse counting, dissociation and progressive muscle relaxation are among the techniques which will be used for deepening of the trance. Non therapeutic and unspecified suggestions will be utilized in this group as placebo control. All sessions will be done between 16 and 20 PM that patients are not tiered. An appropriate room with suitable light and temperature will be chosen for hypnosis sessions.</i_keyword>
      <i_keyword>Intervention group: In this group four sessions of hypnosis will be done. Needed time for hypnosis sessions will range from 15 minutes to one hour depending on the hypnotizability. Different induction techniques would be utilized depending on the age and personal traits. In induction phase of hypnosis some techniques such as eye fixation, progressive muscle relaxation and hand levitation will be used. Imagination, reverse counting, dissociation and progressive muscle relaxation are among the techniques which will be used for deepening of the trance. Therapeutic suggestions will be utilized for disappearing the pain and anxiety. All sessions will be done between 16 and 20 PM that patients are not tiered. An appropriate room with suitable light and temperature will be chosen for hypnosis sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Before intervention, after second and also forth session of intervention. Method of measurement: Visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality  of pain. Timepoint: Before intervention, after second and forth session. Method of measurement: Short form of McGill pain questionnaire.</sec_outcome>
      <sec_outcome>Pain Anxiety. Timepoint: Before intervention, after second and forth session. Method of measurement: Burn Specific Pain Anxiety Scale.</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>Research Vice President of Urmia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-06</approval_date>
        <contact_name>Ethics Board of Urmia University of Medical Scienses</contact_name>
        <contact_address>Urmia University of Medical Scienses, Emergency Alley,Resalat blvd, Urmia Urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
