<?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>IRCT2017042728911N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-26</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences, Vice Chancellor for Research and Technology</primary_sponsor>
      <public_title>Investigation the effect of spiritual care education on postpartum stress disorder</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of spiritual care education on postpartum stress disorder in women with preeclampsia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23349</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>Preeclampsia.</hc_freetext>
      <i_freetext>Intervention 1: The training Spiritual Care intervention was applied in 3 sessions, each 45-60 min in face-to-face. &#13;
Session Contents:&#13;
At the first session:&#13;
A)	Meeting people and assessing the knowledge, attitudes and beliefs of patients and listening to patients' views on spiritual issues, religion and existential issues (separately).&#13;
B)	The role of the reading Qur'an and  praying and in felling calm&#13;
C)	Positive statements based on the Quran and Hadith books.&#13;
&#13;
At the second session:&#13;
A)	Repent and seek forgiveness&#13;
B)	Story of religious people&#13;
C)	Participate in religious programs&#13;
D)	Addressing God and accept the current situation&#13;
E)	Trust, resort, patience, charity (kindness and forgiveness) and focus on the blessings of God&#13;
At the third session:&#13;
A)	explaining the experience of spiritual care and its effects&#13;
B)	Use the consequences  of this care and summarize the past sessions&#13;
During the sessions, the following spiritual care was also provided:&#13;
1)	Trust, empathy and honesty between the nurse and mothers to establish a proper communication during the sessions.&#13;
2)	Listen carefully to the physical &amp; mental problems, worries and fears of patients&#13;
3)	Psychological support required by patients&#13;
4)	Strengthening individuals' inner hope and powers&#13;
5)	Using positive energy sentences and strengthen healthy and constructive thoughts&#13;
6)	Helping the patient find the meaning of life and understanding that none of the life events is beyond the destiny. who believes in God over whole world could be saves from the feeling pessimistic, emptiness and frustrated&#13;
7)	Providing the necessary facilities for religious practices&#13;
8)	Encouraging the patient to read Qur'an and pray&#13;
9)	touching the hands of patients in order to provide them with mental support&#13;
10)	Encouraging the patient to express their religious beliefs&#13;
11)	Encouraging patients to visit religious clerics&#13;
12)	Encouraging patients to refer to people who feel comfortable with them&#13;
13)	Encouraging patients to enjoy entertainment and do light sports activities according to their physician's opinion.&#13;
14)	Assuring the patient that the nurse is always available to her clients for mental and psychological support.&#13;
15)	seek forgiveness from past sins and forsaking anger against the perpetrator and guilty person&#13;
16)	Encouraging the mothers to enjoy music, singing, theater, cinema, art and etc.&#13;
17)	Encourage the patients to establish a friendly relationship with others&#13;
18)	Encouraging the patients to laugh and do their favorite hobbies&#13;
19)	Encouraging  the patients  to participate in religious services and social gatherings. Intervention 2: The control group received routine care.</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>Zahra Kamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Avenue, Crossroads PhD, Ibn Sina Street, School of Nursing and Midwifery, Mashhad.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00985138591511</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>kamaliz921@mums.ac.ir؛ kamalishahla6@gmail.com</email>
        <affiliation>School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Tafazoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Avenue, Crossroads PhD, Ibn Sina Street, School of Nursing and Midwifery, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Tafazolim@mums.ac.ir ؛ http://www.mums.ac.ir/nurse</email>
        <affiliation>Lecturer, Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sc</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Having preeclampsia; Singleton pregnancy and live fetus; gestational age between 32 to 38 week; Iranian citizenship and settle in Mashhad; Having reading and writing ability; Participation in the study; Having a contact number.&#13;
 Exclusion criteria: Having medical conditions; Having obstetric complications apart from preeclampsia; The use of tobacco and drugs; Suicide or thinking about suicide during the past year; Having a history of mental illness or taking psychiatric drugs; Having History of infertility; Having a history of two abortions and more; Getting a score of over 6 from post-traumatic stress disorder (PPQ)  questionnaire in  women multipar; Getting more and more severe scores from the DASS 21 questionnaire in the subscales of anxiety, stress, depression; Getting score above 50 from the post traumatic Disorder checklist (PCL) questionnaire.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O10, O11, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The training Spiritual Care intervention was applied in 3 sessions, each 45-60 min in face-to-face. &#13;
Session Contents:&#13;
At the first session:&#13;
A)	Meeting people and assessing the knowledge, attitudes and beliefs of patients and listening to patients' views on spiritual issues, religion and existential issues (separately).&#13;
B)	The role of the reading Qur'an and  praying and in felling calm&#13;
C)	Positive statements based on the Quran and Hadith books.&#13;
&#13;
At the second session:&#13;
A)	Repent and seek forgiveness&#13;
B)	Story of religious people&#13;
C)	Participate in religious programs&#13;
D)	Addressing God and accept the current situation&#13;
E)	Trust, resort, patience, charity (kindness and forgiveness) and focus on the blessings of God&#13;
At the third session:&#13;
A)	explaining the experience of spiritual care and its effects&#13;
B)	Use the consequences  of this care and summarize the past sessions&#13;
During the sessions, the following spiritual care was also provided:&#13;
1)	Trust, empathy and honesty between the nurse and mothers to establish a proper communication during the sessions.&#13;
2)	Listen carefully to the physical &amp; mental problems, worries and fears of patients&#13;
3)	Psychological support required by patients&#13;
4)	Strengthening individuals' inner hope and powers&#13;
5)	Using positive energy sentences and strengthen healthy and constructive thoughts&#13;
6)	Helping the patient find the meaning of life and understanding that none of the life events is beyond the destiny. who believes in God over whole world could be saves from the feeling pessimistic, emptiness and frustrated&#13;
7)	Providing the necessary facilities for religious practices&#13;
8)	Encouraging the patient to read Qur'an and pray&#13;
9)	touching the hands of patients in order to provide them with mental support&#13;
10)	Encouraging the patient to express their religious beliefs&#13;
11)	Encouraging patients to visit religious clerics&#13;
12)	Encouraging patients to refer to people who feel comfortable with them&#13;
13)	Encouraging patients to enjoy entertainment and do light sports activities according to their physician's opinion.&#13;
14)	Assuring the patient that the nurse is always available to her clients for mental and psychological support.&#13;
15)	seek forgiveness from past sins and forsaking anger against the perpetrator and guilty person&#13;
16)	Encouraging the mothers to enjoy music, singing, theater, cinema, art and etc.&#13;
17)	Encourage the patients to establish a friendly relationship with others&#13;
18)	Encouraging the patients to laugh and do their favorite hobbies&#13;
19)	Encouraging  the patients  to participate in religious services and social gatherings</i_keyword>
      <i_keyword>The control group received routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety, Stress, Depression. Timepoint: Before intervention and Four weeks after childbirth. Method of measurement: Questionnaire DASS21.</prim_outcome>
      <prim_outcome>Spiritual Health. Timepoint: Before intervention and Four weeks after childbirth. Method of measurement: The questionnaires Spiritual Well Ellison &amp; Paloutzian, Being Scale (SWBS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The Post-traumatic stress disorder after childbirth. Timepoint: Four weeks after giving birth. Method of measurement: Instruments Prenatal post traumatic stress question are ( PPQ),.</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>Mashhad University of Medical Sciences, Vice Chancellor for Research and Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-11</approval_date>
        <contact_name>Ethics Committee Mashhad University of Medical Sciences</contact_name>
        <contact_address>Next to the cinema Hoveizeh, University Avenue, Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences, Mashhad. Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
