<?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>IRCT201505056582N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-10-29</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Peer Assisted Learning on Marital Adjustment and quality of life of Infertile Women</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Peer Assisted Learning on Marital Adjustment and quality of life of infertile women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>124</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7042</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>infertility.</hc_freetext>
      <i_freetext>Intervention 1: آhead of peers: the samples of the population with Diploma, who had achieved higher score than the mean in pre-test, will be selected as the head of peers. The researcher will train the heads for two one-hour sessions with one week interval. In first session, all the contents of the training pamphlet including: 1). way of scheduling the meetings and phone calls, 2). the meaning of marital adjustment and way of promoting it, 3). the concept of life quality and way of promoting it, 4). definition of infertility, cause and methods of diagnosing and treatment, and 5). the probability of effect of infertility on marital adjustment and life quality, will be explained and they will be required to study the training booklet by forthcoming week and ask their questions.  intervention groups:The intervention group will be categorized into 10 groups and each peer heads will be randomly allocated to intervention groups and the heads will communicate with group members by phone call for at least 5 minutes every week for 3 months and will answer their questions based on what trained on training  sessions. Intervention 2: Control group:The control group will receive the rootin care of infertility ward.</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>Mahin kamalifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariaty st, Nursing and Midwifery,Tabriz University of Medical Sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 934 796 770</telephone>
        <email>kamalifardm@tzmed.ac.ir</email>
        <affiliation>Nursing and Midwifery,Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin kamalifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariaty st, Nursing &amp; Midwifery, Tabriz University of Medical Sciences</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 34796770</telephone>
        <email>kamalifardm@tbzmed.ac.ir</email>
        <affiliation>Nursing &amp; Midwifery, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  Having Iranian nationality;  Existing the time of at least 6 months and at most 10 years from infertility diagnosis and beginning of treatment; Having the ability to communicate with others;  Having Diploma or higher degrees for selected peers;  Having Azeri language;  Having cellphone;  Not having chronic diseases which have effect on life quality and marital adjustment (diabetes, blood pressure, heart diseases, …);  Having inclination to participate in the study&#13;
Exclusion criteria: Having physical limitations which have effect on life style (deafness, blindness, deformity, and ….); Having psychological diseases based on her statements and her file in herself or in her husband;  Occurring horrible and stressful events during the study;  Having stepchild or child that lives with the couples.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>n97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Female infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>آhead of peers: the samples of the population with Diploma, who had achieved higher score than the mean in pre-test, will be selected as the head of peers. The researcher will train the heads for two one-hour sessions with one week interval. In first session, all the contents of the training pamphlet including: 1). way of scheduling the meetings and phone calls, 2). the meaning of marital adjustment and way of promoting it, 3). the concept of life quality and way of promoting it, 4). definition of infertility, cause and methods of diagnosing and treatment, and 5). the probability of effect of infertility on marital adjustment and life quality, will be explained and they will be required to study the training booklet by forthcoming week and ask their questions.  intervention groups:The intervention group will be categorized into 10 groups and each peer heads will be randomly allocated to intervention groups and the heads will communicate with group members by phone call for at least 5 minutes every week for 3 months and will answer their questions based on what trained on training  sessions</i_keyword>
      <i_keyword>Control group:The control group will receive the rootin care of infertility ward.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Marital Adjustment. Timepoint: before intervention and after 3 month. Method of measurement: Lock Wallace Marital Adjustment Test questionaires.</prim_outcome>
      <prim_outcome>. Timepoint: . Method of measurement: .</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-13</approval_date>
        <contact_name>ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz University of Medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
