<?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>IRCT20181217042027N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of trembling blankets and eye movements desensitization on post-traumatic stress</public_title>
      <acronym>PTSD &amp; EMDR</acronym>
      <scientific_title>Comparison of Effectiveness of Intervention with the Methods of Trembling Blanket and EMDR, on PTSD</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36045</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: One of the treatments used in the research is trembling  blanket exposure treatment, which is a researcher's innovative technique, and is the first to be scientifically examined, Randomization description: A simple randomization will be used using the lottery, Blinding description: It is explained to the participants that they participate in a pilot study, but they do not describe how the implementation of them will be different from the method of implementation on the other group, nor will they be aware of the information of other groups. Relationship between groups is controlled by the end of the experiment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Post traumatic stress disorder.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group:                                                         intervention using eye degradation and retardation; the intervention group's interventional group with sensory degeneration with eye movements and rehabilitation included: 1- Acquiring the necessary information 2- Preparing the therapist 3- Evaluation 4. Sensitization 5. Brokerage 6- Checking Physical 7. Closing 8. Re-evaluation. Intervention 2: Intervention group: the intervention by the trembling blanket method; the intervention stages include: 1) an effective and intimate relationship between the therapist (therapeutic communication) and the therapist; 2) the logic of this technique is explained, so that the treatment acquaints with the treatment model 3. Creating mutual trust between the therapist and the therapist in order to facilitate the process of treatment; 4- Preparing a therapist for participation in treatment; and Finally, arranging for a blanket and treatment. Intervention 3: Control group:  no interventions are performed.</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:
Part of the data, such as information on the main implications and effectiveness, and the comparison of the two interventions, are published.

When:
Three months after printing results.

To whom:
Researchers and therapists in the field of health, medical sciences universities, the Welfare Organization, the Committee for Psychosocial Interventions of Academic Societies and the Red Crescent Society.

Conditions:
Observing professional and ethical principles in research. Like mentioning the source.

Where to obtain:
Email the researcher to:
psy.h.maleki@gmail.com

How to obtain:
In an email, let us know about the scope and use of the results. After review, a maximum of two weeks will be answered.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran-Qom Province- Boulevard Republic-Alley 42- Teachers Building 1- Unit 145</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3716749994</zip>
        <telephone>+98 25 3261 1141</telephone>
        <email>psy.h.maleki@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran - Qom - Republic Blvd - Teachers Building 1 - Unit 145</address>
        <city>qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>371679994</zip>
        <telephone>+98 252611141</telephone>
        <email>psy.h.maleki@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 7 to 10 years.
Being male.
Acquiring a score from the post traumatic stress disorder check-list based on the fifth edition of the diagnostic and statistical manual disorder (PCL-5).
The consent of the subject to participate in the research. (written consent)
The subject has the ability to follow eye movements.
Lack of intervention, psychotherapy and medication simultaneousy.</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>10 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Dissatisfaction and cooperation The research sample.
Get treatment at the same time.
Family history of earthquakes.
There is a disorder at the same time.</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group:                                                         intervention using eye degradation and retardation; the intervention group's interventional group with sensory degeneration with eye movements and rehabilitation included: 1- Acquiring the necessary information 2- Preparing the therapist 3- Evaluation 4. Sensitization 5. Brokerage 6- Checking Physical 7. Closing 8. Re-evaluation.</i_keyword>
      <i_keyword>Intervention group: the intervention by the trembling blanket method; the intervention stages include: 1) an effective and intimate relationship between the therapist (therapeutic communication) and the therapist; 2) the logic of this technique is explained, so that the treatment acquaints with the treatment model 3. Creating mutual trust between the therapist and the therapist in order to facilitate the process of treatment; 4- Preparing a therapist for participation in treatment; and Finally, arranging for a blanket and treatment.</i_keyword>
      <i_keyword>Control group:  no interventions are performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of people who have a post-traumatic stress disorder score list is above 33. Timepoint: Measuring the rate of post-traumatic stress disorder before intervention and 7, 14 and 21 days after intervention. Method of measurement: Structured diagnostic interview based on the fifth Diagnostic and Statistical Manual of Psychiatric Disorders and the Post Traumatic Stress Disorder Checklist questionnaire are based on the fifth edition of the Diagnostic and Statistical Manual of Psychiatric Disorders (PCL-5).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Score of post traumatic stress disorder. Timepoint: Measurement of post-traumatic stress disorder before intervention, 7, 14 and 21 days after intervention. Method of measurement: The Post Traumatic Stress Disorder Checklist is also based on the fifth edition of the PCL-5 Diagnostic and Statistical Manual of Mental Disorders.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-08</approval_date>
        <contact_name>Ethics Committee of Biomedical Sciences of Islamic Azad University of Qom</contact_name>
        <contact_address>15th Khordad Avenue, Islamic Azad University of Qom Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
