<?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>IRCT20170122032101N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-17</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>‏   Comparing the effect of distraction of thought and prayer on pain and anxiety in patients with extracorporeal shock wave lithotripsy(ESWL)</public_title>
      <acronym>ESWL</acronym>
      <scientific_title>Comparing the effect of distraction of thought and prayer on pain and anxiety in patients with extracorporeal shock wave lithotripsy(ESWL)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37611</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by blocking method based on group variables and a history of rock breakdown. The number of blocks is obtained by multiplying the states of each variable. The age group of five states (18-25, 35-25, 45-35, 55-45, and over 55 years old) and a history of rock breakdown of two states (previous history of rock formation, previous history of rock It will not break). A total of 10 blocks will be determined. The capacity of each block is obtained by dividing the total sample size by the number of blocks, each block having capacity for 18 people. Since the study consists of three groups, each block of 18 people will be divided into three groups of six. In order to allocate each block to the test group one (deviation), test two (prayer) and control, the researcher first will determine, based on the patient information, which block belongs to each patient, then from the file number Patient, patients whose case numbers were 2-0, in the test group one (deviant), patients whose file numbers were between 5-3, in the test group two (Prayer) and patients whose file numbers are 6 to 6, will be assigned to the control group and patients with a file number of 9 will be excluded from participation in the study. , Blinding description: Samples do not know how to enter the groups and they are blindly entered into an intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>extracorporeal shock wave lithotripsy.</hc_freetext>
      <i_freetext>Intervention 1: First, during the process of ESWL after the routine treatment, the McGill pain questionnaire and the 20 questions of the Espill Berger questionnaire, which is related to the apparent anxiety, will be completed, and then in the group receiving thedistraction, On routine drug therapy, nature sounds accompanied by beautiful nature images will be used to relieve pain and anxiety. Then again, the McGill pain questionnaire and the anxiety section of the Spielberger Anxiety Inventory will be completed again in all three groups. Intervention 2: First, during routine process, after the routine treatment, the McGill Pain Questionnaire and the 20-item Spielberger questionnaire, which is related to the apparent anxiety, will be completed. In the group receiving prayer, in addition to drug therapy, the patient will repeatedly mention the prayers of "Allah, peace be upon him, Muhammad and Al-Muhammad". The control group will receive routine care. In all three groups, if the pain is expressed, the patient will receive the repeated doses and the dose and the frequency of duplication of the patient. Then again, the McGill pain questionnaire and the anxiety section of the Spielberger Anxiety Inventory will be completed again in all three groups.</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:
Article

When:
2 years

To whom:
All authors

Conditions:
For using of result

Where to obtain:
Haydeh Heidari

How to obtain:
E mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Haydeh Heidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No10, Vahdat street, Shahrekord city</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8814814776</zip>
        <telephone>+98 38 3333 6699</telephone>
        <email>heidari.h@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haydeh Heidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 10, Vahdat street, Shahrekord city</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8814814776</zip>
        <telephone>+98 38 3333 6699</telephone>
        <email>haydehheidari@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidates for ESWL
Having reading and writing skills
No anti-anxiety drugs received in the last 24 hours,
The absence of underlying illnesses that cause pain or anxiety
Lack of active mental illness or mental retardation
Absence of blood anticoagulant
No previous history of depression and anxiety and severe stressful events in life over the last 6 months,
Not having thyroid disease
Awareness of the patient to the person, time, place</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue to participate in research 
Children
UTI
Coagolopathy
Pregnancy
Patients once studied by us</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First, during the process of ESWL after the routine treatment, the McGill pain questionnaire and the 20 questions of the Espill Berger questionnaire, which is related to the apparent anxiety, will be completed, and then in the group receiving thedistraction, On routine drug therapy, nature sounds accompanied by beautiful nature images will be used to relieve pain and anxiety. Then again, the McGill pain questionnaire and the anxiety section of the Spielberger Anxiety Inventory will be completed again in all three groups.</i_keyword>
      <i_keyword>First, during routine process, after the routine treatment, the McGill Pain Questionnaire and the 20-item Spielberger questionnaire, which is related to the apparent anxiety, will be completed. In the group receiving prayer, in addition to drug therapy, the patient will repeatedly mention the prayers of "Allah, peace be upon him, Muhammad and Al-Muhammad". The control group will receive routine care. In all three groups, if the pain is expressed, the patient will receive the repeated doses and the dose and the frequency of duplication of the patient. Then again, the McGill pain questionnaire and the anxiety section of the Spielberger Anxiety Inventory will be completed again in all three groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before and after intervention. Method of measurement: MC GILL.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: Before and after intervention. Method of measurement: Spill Berger.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-19</approval_date>
        <contact_name>Ethics committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>No 10, KashaniAve., Shahrekord city Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
