<?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>IRCT201509261788N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-09</date_registration>
      <primary_sponsor>center for nursing care reaserch Iran University of Medical Sciences</primary_sponsor>
      <public_title>Stress management  to stress in nurses at Neonatal Intensive Care Units "</public_title>
      <acronym>not applicable</acronym>
      <scientific_title>The effects of stress management program on response to stress in nurses at Neonatal Intensive Care Units "</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1372</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, McNamara stress management is used in six one-hour sessions during six weeks, when NICU nurses receive educational intervention in groups of six. In each session, new topics are presented after reviewing previous ones, and issues discussed are summed up at the end of the session. &#13;
Session one: Introduction to the importance of learning stress management skills; presenting definitions of stress.&#13;
Session two: Introducing general effects of stress on various body systems, and examining physical, psychological, and behavioral effects of stress.&#13;
Session three: Subjective and rational strategies for dealing with stress, and introducing problem-oriented and emotion-oriented methods as coping strategies, examining coping methods adopted by people in  stressful situations.&#13;
Session four: Introducing steps of coping skills, and working on the first stage: being aware of own feelings.&#13;
Session five: The second step of stress control skills, physical ways of coping with stress: these are concerned with a healthier lifestyle, and include healthy nutrition, and sufficient sleep and exercise, which maintain and strengthen the immune system and increase energy level.&#13;
Session six: Review of comments expressed by nurses and obtaining feedback, and SRI posttest. Personnel's stress is measured using pretest and posttest, and stress levels in two groups are compared through posttest and follow-up test. Eight weeks later, SRI is made available to nurses in the intervention group (posttest), in order to assess sustainability over time of stress management education provided by the researcher. Intervention 2: Control group: No action is taken.</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>Leili Borimnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasemi Street , Nursing and Midwhery School</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 8888 2886</telephone>
        <email>l.borimnejad@gmail.com</email>
        <affiliation>Iran University Of  Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leili Borimnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasemi Street, Nursing and Midwifery School</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 8888 2886</telephone>
        <email>l.borimnejad@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Complete personal consent for participation in the study; a minimum of one year's clinical work experience; Bachelor’s degree or higher; no use of psychotropic drugs; working for four to six days per week; or 31 to 40 hours per week. Exclusion criteria: current depression; self-reported acute and chronic somatic or psychiatric disorders; medication.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Reaction to severe stress, and adjustment disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, McNamara stress management is used in six one-hour sessions during six weeks, when NICU nurses receive educational intervention in groups of six. In each session, new topics are presented after reviewing previous ones, and issues discussed are summed up at the end of the session. &#13;
Session one: Introduction to the importance of learning stress management skills; presenting definitions of stress.&#13;
Session two: Introducing general effects of stress on various body systems, and examining physical, psychological, and behavioral effects of stress.&#13;
Session three: Subjective and rational strategies for dealing with stress, and introducing problem-oriented and emotion-oriented methods as coping strategies, examining coping methods adopted by people in  stressful situations.&#13;
Session four: Introducing steps of coping skills, and working on the first stage: being aware of own feelings.&#13;
Session five: The second step of stress control skills, physical ways of coping with stress: these are concerned with a healthier lifestyle, and include healthy nutrition, and sufficient sleep and exercise, which maintain and strengthen the immune system and increase energy level.&#13;
Session six: Review of comments expressed by nurses and obtaining feedback, and SRI posttest. Personnel's stress is measured using pretest and posttest, and stress levels in two groups are compared through posttest and follow-up test. Eight weeks later, SRI is made available to nurses in the intervention group (posttest), in order to assess sustainability over time of stress management education provided by the researcher.</i_keyword>
      <i_keyword>Control group: No action is taken</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress managment. Timepoint: before, Immediately after the treatment, after eight  week. Method of measurement: SRI Questionnare.</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>center for nursing care reaserch Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-05</approval_date>
        <contact_name>Iran University of Medical Sciences and Health Services</contact_name>
        <contact_address>Iran, Tehran, Shahid  Hemmat Highway West, between the intersection of Sheikh fazlolah Nori and Shahid  Chamran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
