<?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>IRCT20200827048546N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-06</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Assessing The effect of provision of information on patient  anxiety and comfort in Extracorporeal Shock Wave Lithotripsy</public_title>
      <acronym></acronym>
      <scientific_title>Assessing The effect of provision of information by video and lecture before Extracorporeal Shock Wave Lithotripsy on patient  anxiety and comfort</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>122</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50670</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling in this research is done in two stages.In the first step, the samples are selected by the Convenience Sampling method.
In the second stage, the allocation of samples to the two groups of intervention and control is done randomly and by blocking method; 
The letter A is considered for the intervention group and the letter B for the control group.

Then we write all the combinations of the letters A, A,and B ,B, which are 6 different combinations, on 6 cards:
1.	AABB 
2.	ABBA 
3.	ABAB 
4.	BAAB 
5.	BABA 
6.	BBAA
Then, from digits 1 to 6, a digit is randomly selected(
With the help of a table of random numbers or patient number one is asked to choose a card at random.)
For example, if the digit 2 is selected This means that the first person is in the intervention group and the next two people  are in the control group and the fourth person is in the intervention group and This Process continues until the sample size reaches the quorum.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Urinary tract stones. Condition 2: Extracorporeal Shock Wave Lithotripsy. Condition 3: Anxiety. Condition 4: Comfort. Condition 5: Cortisol. Condition 6: Physiological indicators.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: To the intervention group in order to inform  before the operation, in the morning of the operation  Researcher With face-to-face speeches in groups of 3-4 in the conference room talks about Information included Introduction of urinary tract, how to create kidney stones and its types, symptoms, method of prevention, diagnosis and treatment, extracorporeal lithotripsy procedure, complications, care and postoperative follow-up and then play a video that shows Location, procedure, place of postoperative hospitalization This intervention takes 30 minutes Patients' questions are also answered for 30 minutes. Intervention 2: Control group: The control group receives the information according to the previous routine.</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:
Will be published

When:
3 months after the publication of the results

To whom:
For all

Conditions:
To increase knowledge in this field

Where to obtain:
saeedeh.azizi2013@gmail.com

How to obtain:
It will be done as soon as possible after requesting by email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeedeh Azizi Mahkooyeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12, Vali Asr avenue, Bagherabadd, Varamin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1869676759</zip>
        <telephone>0098 21 09307549330</telephone>
        <email>saeedeh.azizi2013@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeedeh Azizi Mahkooyeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 12, Valiasr 7, Valiasr avenue, Bagherabad, Varamin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1869676759</zip>
        <telephone>+98 21 3613 4292</telephone>
        <email>Saeedeh.azizi2013@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient with urinary stone Disease and  ESWL candidate
Willingness to cooperate in the project
Ages 18 to 65 years
The first experience of ESWL
Ability to read and write
No membership in the treatment team
Lack of vision and hearing problems
Do not take medications that reduce or increase cortisol like Corticosteroids, anticonvulsants, insulin
Do not use sedatives and anti-anxiety drugs before the intervention</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any patient dissatisfaction during the research
Any acute problems at the time of the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N20.9</hc_code>
      <hc_code></hc_code>
      <hc_code>F06.4</hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Urinary calculus, unspecified</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: To the intervention group in order to inform  before the operation, in the morning of the operation  Researcher With face-to-face speeches in groups of 3-4 in the conference room talks about Information included Introduction of urinary tract, how to create kidney stones and its types, symptoms, method of prevention, diagnosis and treatment, extracorporeal lithotripsy procedure, complications, care and postoperative follow-up and then play a video that shows Location, procedure, place of postoperative hospitalization This intervention takes 30 minutes Patients' questions are also answered for 30 minutes.</i_keyword>
      <i_keyword>Control group: The control group receives the information according to the previous routine.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in Spielberger's anxiety questionnaire. Timepoint: Completion of the questionnaire before the intervention and after the awareness. Method of measurement: Spielberger Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Measuring anxiety with salivary cortisol levels. Timepoint: Before the intervention and after the awareness. Method of measurement: Saliva sample in the amount of 3 to 5 cc.</prim_outcome>
      <prim_outcome>Anxiety level by measuring the number of breaths, pulse rate and blood pressure. Timepoint: Before the intervention and after the awareness. Method of measurement: Count the number of breaths and pulses per minute And measuring blood pressure with a mercury sphygmomanometer.</prim_outcome>
      <prim_outcome>Comfort score on the Kolkaba General Comfort Questionnaire. Timepoint: Before the intervention and after the awareness. Method of measurement: Kolkaba General Comfort Questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-23</approval_date>
        <contact_name>Ethics committee of Nursing And Midwifery  and Rehabilitation School, Tehran University Of Medical S</contact_name>
        <contact_address>Tehran Province, Tehran, District 6, Nosrat St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
