<?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>IRCT2017010331753N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-30</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of two method of preoperative training on anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effect of pre-operative educational ‎approach by nurses and peers on anxiety of the women ‎undergoing ovarian puncture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>210</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24912</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In this study, individuals were assigned to three groups using permutation block method, Randomization description: Sampling was performed using special randomized software with permutation block method with a volume of 6 people and eligible samples were placed in one of the three groups of nurse training, peer training and control.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: anxiety. Condition 2: infertility.</hc_freetext>
      <i_freetext>Intervention 1: Preoperative training by a nurse: The nurse-educated group was on 30-60 min group education program after the completion of the primary questionnaire.The educational package contained the type and duration of surgery, postoperative cares, including diet, medicine consumption, the qualityand amount of rest after surgery, and postoperative activity. During this education, the nurse was allowed to express positive experiences. The questionnaire was filled out in a self-reportmanner in the researcher’s presence at the timeof admission (two days before the operation) andimmediately after the intervention (prior to surgery). Intervention 2: Preoperative training by a peer: The peer-educated group was on 30-60 min group education program after the completion of the primary questionnaire.The educational package contained the type and duration of surgery, postoperative cares, including diet, medicine consumption, the qualityand amount of rest after surgery, and postoperative activity. During this education, the peer was allowed to express positive experiences. To educate the peer group, three qualified peerswere selected according to the following criteria:history of successful ovarian puncture, high schooldiploma or higher, and having low levels of anxietybased on the STAI. These selected peers wereeducated before sampling by the nurse educatorof another group about their roles in the study,the importance of instructing patients, and theeducational content in two sessions. Then, throughan experimental instruction, one of the peers wasselected as the educator for the peer-educatedgroup. She was a 24-yr-old housewife and aresident of Yazd who had a high school diplomaand a child from IVF.The questionnaire was filled out in a self-reportmanner in the researcher’s presence at the timeof admission (two days before the operation) andimmediately after the intervention (prior to surgery). Intervention 3: the control group was only educated at the time of their discharge, which is part of the section’s routines.</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:
The data from the study were published as an article.

When:
Since 1401

To whom:
All people in the field of medicine and nursing

Conditions:
To reduce preoperative anxiety in surgical candidates

Where to obtain:
Email to the person performing the project

How to obtain:
Email to the moderator -  Request from the Vice Chancellor for Research- If yes, provide information to the applicant

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atharah Kalantari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Ave, Safaeyeh, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 3525 2291</telephone>
        <email>a.kalantari@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farahnaz Farnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bouali Ave, Timsar Falahi street</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>916777443</zip>
        <telephone>+98 35 3824 5777</telephone>
        <email>farnia@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidate patients undergo ovarian puncture
Willingness to participate in the study
Age between 18 and 45 years
knowledge persian language
Literacy for reading and writing</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mental illness, addiction, cancer
Taking anti-anxiety drugs
Donor</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>generalized anxiety disorder</hc_keyword>
      <hc_keyword>Female infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Preoperative training by a nurse: The nurse-educated group was on 30-60 min group education program after the completion of the primary questionnaire.The educational package contained the type and duration of surgery, postoperative cares, including diet, medicine consumption, the qualityand amount of rest after surgery, and postoperative activity. During this education, the nurse was allowed to express positive experiences. The questionnaire was filled out in a self-reportmanner in the researcher’s presence at the timeof admission (two days before the operation) andimmediately after the intervention (prior to surgery).</i_keyword>
      <i_keyword>Preoperative training by a peer: The peer-educated group was on 30-60 min group education program after the completion of the primary questionnaire.The educational package contained the type and duration of surgery, postoperative cares, including diet, medicine consumption, the qualityand amount of rest after surgery, and postoperative activity. During this education, the peer was allowed to express positive experiences. To educate the peer group, three qualified peerswere selected according to the following criteria:history of successful ovarian puncture, high schooldiploma or higher, and having low levels of anxietybased on the STAI. These selected peers wereeducated before sampling by the nurse educatorof another group about their roles in the study,the importance of instructing patients, and theeducational content in two sessions. Then, throughan experimental instruction, one of the peers wasselected as the educator for the peer-educatedgroup. She was a 24-yr-old housewife and aresident of Yazd who had a high school diplomaand a child from IVF.The questionnaire was filled out in a self-reportmanner in the researcher’s presence at the timeof admission (two days before the operation) andimmediately after the intervention (prior to surgery)</i_keyword>
      <i_keyword>the control group was only educated at the time of their discharge, which is part of the section’s routines.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Baseline, preoperative. Method of measurement: Spielberger 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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-01</approval_date>
        <contact_name>Ethics committee of Yazd University of Medical Sciences</contact_name>
        <contact_address>Yazd University of Medical Sciences, Bahonar Square Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-12</approval_date>
        <contact_name>Ethics committee Research and Clinical Center for Infertility, Yazd, Iran</contact_name>
        <contact_address>Safaieh ، Bouali Street yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
