<?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>IRCT20150731023423N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-01</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of spirituality counseling on the quality of life of preeclamptic women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of counseling with spirituality-oriented approach on quality of life after childbirth in women with preeclampsia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50832</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible samples will be selected by convenience sampling method and then randomly assigned to 4 control and intervention groups of 4 blocks. For the intervention group, one-on-one counseling with a spirituality-based approach based on the Richards and Bergin's pattern protocol will be held in 5 sessions. Three face-to-face counseling sessions for 45-60 minutes during hospital stay and two sessions of postpartum telephone counseling weekly after discharge. (39, 43). The control group will receive routine care. Data collection tools include demographic characteristics questionnaire, postpartum quality of life questionnaire, general health questionnaire: GHQ and DSES questionnaire (daily spiritual experiences) which in two stages before the intervention and 6 weeks after the end of counseling sessions by research units. Complete and will be analyzed using SPSS statistical software version 20 and statistical methods of chi-square, independent t-test and paired t-test, MANCOVA statistical methods and multivariate analysis of variance MANOVA in case of abnormal distribution of non-parametric tests The equivalent will be used.</study_design>
      <phase>3</phase>
      <hc_freetext>Quality of life after childbirth in women with preeclampsia.</hc_freetext>
      <i_freetext>Intervention group: The intervention group will receive three face-to-face counseling sessions for 45-60 minutes during hospitalization and two sessions of telephone postpartum counseling weekly after discharge. The contents of the sessions include introducing oneself and getting to know the patient, expressing the goals of the project, creating empathy, talking about the disease, assessing the mental condition and physical condition, paying attention to the patient's attitude towards the disease, physical health, negative emotions, stress and worries and strategies to deal with them. About the concept of quality of life, dimensions of quality of life and the importance of self-awareness, belief, values ​​in life. Talking about one's expectations of life, community, values, attitude towards spiritual issues, the role of God and religion in life Talk about Positive experiences of the patient about the use of spiritual issues in dealing with stressful situations in life Recalling the role of women in creation, spiritual aspects of pregnancy and childbirth, maternal role from the perspective of Islam, review of the previous session With breathing exercises and repeating it 10 to 15 times a day, it is recommended to listen to the music of nature, the sound of the Quran during the day, the role of charity, trust, recourse, patience, charity (kindness and forgiveness) and focusing on God's blessings in reducing stress. Pre-assessment sessions on a person's mood, attitude and beliefs The role of gratitude to God in enduring hardships, increasing hope and self-confidence in adjustment and accepting the position of the role of reading the Bible in patients' comfort, the story of religious people, encouraging patients to talk to people who make them feel positive, increasing intimacy with spouse Using their participation in life-centered counseling responsibilities in telephone follow-up sessions will include reviewing and recalling the content of face-to-face counseling sessions. Including trust, empathy and honesty between midwives and mothers to communicate properly during the sessions..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Possibility of Dissatisfaction of Participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Robab Rasouli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>دانشگاه علوم پزشکی زنجان، جاده گاوازنگ</address>
        <city>zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4514938017</zip>
        <telephone>+98 24 3373 7751</telephone>
        <email>robabrasouli1010@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan University of Medical Sciences Gavazang Road</address>
        <city>zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515613191</zip>
        <telephone>+98 24 3342 0651</telephone>
        <email>Malekia@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- Preeclampsia                                                                                            - Hospitalization less than 5 days                                                         - No other concomitant chronic diseases (diabetes - Kidney disease - Cancer)                                                                                  - No known mental illness                                                                   - Willingness to participate in the study                                              - Having a delivery with a singleton pregnancy, withoabnormalities Known Infant  - Intrauterine Infant Death                                                   -Literacy for reading and writing                                                         - Score less than 22 based on GHQ-28 General Health Questionnaire
- Hospitalization less than 5 days
- No other concomitant chronic diseases (diabetes - Kidney disease - Cancer)
- No known mental illness
- Willingness to participate in the study
- Having a delivery with a singleton pregnancy, withoabnormalities Known Infant  - Intrauterine Infant Death
-Literacy for reading and writing
- Score less than 22 based on GHQ-28 General Health Questionnaire</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having postpartum complications (bleeding, infection, etc.)
Infant death
Reluctance to continue cooperation in the study
Changing the treatment process (eg transfer to the intensive care unit)
Failure to answer a phone call during the follow-up period</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will receive three face-to-face counseling sessions for 45-60 minutes during hospitalization and two sessions of telephone postpartum counseling weekly after discharge. The contents of the sessions include introducing oneself and getting to know the patient, expressing the goals of the project, creating empathy, talking about the disease, assessing the mental condition and physical condition, paying attention to the patient's attitude towards the disease, physical health, negative emotions, stress and worries and strategies to deal with them. About the concept of quality of life, dimensions of quality of life and the importance of self-awareness, belief, values ​​in life. Talking about one's expectations of life, community, values, attitude towards spiritual issues, the role of God and religion in life Talk about Positive experiences of the patient about the use of spiritual issues in dealing with stressful situations in life Recalling the role of women in creation, spiritual aspects of pregnancy and childbirth, maternal role from the perspective of Islam, review of the previous session With breathing exercises and repeating it 10 to 15 times a day, it is recommended to listen to the music of nature, the sound of the Quran during the day, the role of charity, trust, recourse, patience, charity (kindness and forgiveness) and focusing on God's blessings in reducing stress. Pre-assessment sessions on a person's mood, attitude and beliefs The role of gratitude to God in enduring hardships, increasing hope and self-confidence in adjustment and accepting the position of the role of reading the Bible in patients' comfort, the story of religious people, encouraging patients to talk to people who make them feel positive, increasing intimacy with spouse Using their participation in life-centered counseling responsibilities in telephone follow-up sessions will include reviewing and recalling the content of face-to-face counseling sessions. Including trust, empathy and honesty between midwives and mothers to communicate properly during the sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of spirituality-oriented counseling on quality of life after childbirth in women with preeclampsia. Timepoint: Three sessions of spiritual counseling modeled on Richards and Bergin, in person for 45-60 minutes during hospital stay and two sessions of telephone counseling weekly after discharge. Method of measurement: , Postpartum Quality of Life Questionnaire, General Health Questionnaire: GHQ, DSES Questionnaire (Daily Spiritual Experiences).</prim_outcome>
      <prim_outcome>Quality of life after childbirth in women with preeclampsia. Timepoint: Three sessions of spiritual counseling modeled on Richards and Bergin, in person for 45-60 minutes during hospital stay and two sessions of telephone counseling weekly after discharge. Method of measurement: Postpartum Quality of Life Questionnaire, General Health Questionnaire: GHQ, DSES Questionnaire (Daily Spiritual Experiences).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: In two stages before the intervention and 6 weeks after the end of the consultation sessions by the research units. Method of measurement: General Health Questionnaire: GHQ, DSES Questionnaire (Daily Spiritual Experiences).</sec_outcome>
      <sec_outcome>Quality of life after childbirth in women with preeclampsia. Timepoint: In two stages before the intervention and 6 weeks after the end of the consultation sessions by the research units. Method of measurement: Postpartum Quality of Life Questionnaire.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-10</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan Azadi Blvd. Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
