<?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>IRCT201604205596N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-01</date_registration>
      <primary_sponsor>Lorestan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of supportive-educational intervention on the level of stress, depression, anxiety, perceived social support, and satisfaction of the caregivers of the patients</public_title>
      <acronym>depression, anxiety and stress scale, DASS</acronym>
      <scientific_title>Comparison of the effect of receiving and not-receiving supportive-educational intervention on the level of stress, depression, anxiety, perceived social support, and satisfaction of the caregivers of the patients undergoing gynecological surgery; a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6015</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Randomization is performed using random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Stress. Condition 2: Anxiety. Condition 3: Depression. Condition 4: Satisfaction. Condition 5: Perceived social support.</hc_freetext>
      <i_freetext>Intervention 1: The patients’ caregivers being in the waiting room will be presented via supportive educational program by operating theater nurse in form of speech, question and answer, and slides by a monitor. This international program will be in 6 steps, and each step will take 10 minutes long. The educational points will be about postoperative cares; the principles and arrangements of traffic and visit; correct and effective communication. The necessary information will be presented to the patient’s caregiver in educational programs intervals. Each caregiver will be visited by operating theater nurse to receive support and answers of the questions sporadically for at least 10 minutes. Intervention 2: The control group will receive no education.</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>Nasrin Galehdar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Paramedical faculty, Goldasht, Khorramabad, Lorestan</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 66 3340 9971</telephone>
        <email>galehdar.n@lums.ac.ir; galehdr_nas@yahoo.co.in</email>
        <affiliation>Lorestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nasrin Galehdar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Paramedical faculty, Goldasht, Khorramabad, Lorestan</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 66 3340 9971</telephone>
        <email>galehdar.n@lums.ac.ir; galehdr_nas@yahoo.co.in</email>
        <affiliation>Lorestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Desire to participate in the study; ability to perceive and fill out the questionnaire; lack of psychological disease; the age between 18 to 55 years old; lack of participation in current similar study; being of patient caregiver in the hospital and waiting room in time of surgery; being literate.&#13;
Exclusion criteria: Lack of desire to continue cooperation in each step of the study; decease of the patient.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.0</hc_code>
      <hc_code>F41.9</hc_code>
      <hc_code>F32.0</hc_code>
      <hc_code>-</hc_code>
      <hc_code>-</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute stress reaction</hc_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
      <hc_keyword>Mild depressive episode</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>The patients’ caregivers being in the waiting room will be presented via supportive educational program by operating theater nurse in form of speech, question and answer, and slides by a monitor. This international program will be in 6 steps, and each step will take 10 minutes long. The educational points will be about postoperative cares; the principles and arrangements of traffic and visit; correct and effective communication. The necessary information will be presented to the patient’s caregiver in educational programs intervals. Each caregiver will be visited by operating theater nurse to receive support and answers of the questions sporadically for at least 10 minutes.</i_keyword>
      <i_keyword>The control group will receive no education</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The level of depression, anxiety and stress of the caregivers. Timepoint: Upon arrival of the patient to the operating room and in the first visit with caregiver and in time of patient’s exit of the operating theater. Method of measurement: Depression, Anxiety and stress scale(DASS21).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The level of satisfaction. Timepoint: Upon arrival of the patient to the operating room and in the first visit with caregiver and in time of patient’s exit of the operating theater. Method of measurement: The self made questionnaire.</sec_outcome>
      <sec_outcome>Perceived social support. Timepoint: Upon arrival of the patient to the operating room and in the first visit with caregiver and in time of patient’s exit of the operating theater. Method of measurement: The multidimensional scale perceived social support.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Isfahan University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Lorestan University of Medical Sciences</source_name>
      <source_name>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-04-06</approval_date>
        <contact_name>Ethics committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Lorestan University of Medical Sciences, Pardis campus, Kamalvand, Khorramabad, Lorestan Khorramabad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
