<?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>IRCT20181207041873N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-28</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Spiritual Education on Coping Strategies in Infertile Women</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Spiritual Education on Coping Strategies in Infertile Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36861</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The introduction of the letter and necessary permits from the university is for the Infertility Centers of Qom Jihad and the Reyhane Infertility Center in Forghani Hospital. After entering the research environment, the researcher will begin to sample the infertility centers after introducing and explaining his goals. In order to prevent data contamination, depending on the nature of the research subject, the sampling site of the two test and control groups is independent of each other. At first, one of the centers of infertility is allocated to the control group as a test site and the other is drawn to the control group by drawing lots. Sampling will be carried out in accessible form and the samples will be in two groups of intervention (n = 45) and control (n = 45). After the necessary explanation of the research, its goals and the confidentiality of the research data, the written samples will be taken from the sample, and demographic questionnaires and coping strategies will be provided to them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coping strategies used in infertile women.</hc_freetext>
      <i_freetext>Intervention group: The test group will participate in a group for 6 weeks in 6 sessions. Each session will run 90 minutes. The number of people in each training group will be six to eight. The two sessions of the six sessions that will be held in the third and sixth weeks will be the subject of theoretical knowledge in the areas of spirituality and religion that will be the main responsibility of the education that the researcher will attend in these two sessions, Training will follow the recommendations of the expert. The tool is used in group video projector (Powerpoint) and whiteboard meetings. The contents of the training sessions will be held at office hours and at the Infertility Center. Each training session is held in the form of a lecture and a question and answer to questions on previously defined topics in the booklet. In the last fifteen minutes, a summary of the contents will be done with the help of research units and the contents of each session will be provided to the test group. The content of the meetings is marked with details in Table (1). Trainings will be provided by the researcher. It should be noted that the researcher will participate in workshops on spiritual training for proper intervention. The test group three times: Before the intervention, at the end of the last training session and eight weeks after the completion of the training sessions, the Lazarus coping strategies questionnaire will be completed.  The content of the meetings is specified in the table (1) with details. Trainings will be provided by the researcher. It should be noted that the researcher will participate in workshops on spiritual training for proper intervention. The test group will complete the Lazarus coping strategies questionnaire three times before the intervention, at the end of the last training session and eight weeks after the completion of the training sessions. Discussion 1: Introduction of the researcher and reestablishment of goals, familiarity with the research units, discussion On the dimensions of human existence, especially its spiritual dimension and the needs of each dimension. Session 2: The importance of self-consciousness in the spiritual dimension, talking about the characteristics of the spiritual person, encouraging the patient to reveal the ideas and spiritual experiences themselves. Session 3: Talking about the meaning of life and methods of meaningfulness to life, encouraging research units to positively impart life experiences. Session 4: Methods for raising the religious and spiritual dimension: Encouraging the patient to participate in spiritual-religious programs, going to religious places, joining spiritual groups, assigning time to keep up with God. Session 5: Encourage the patient to use appropriate coping strategies such as trust, patience, forgiveness and the effects of mentioning God. Session 6: Problem-Solving Problem with Spiritual Approach, Completion of Lazarus Coping Strategies Questionnaire by Research Units                                              Control group: The health care center will receive the Infertility Center. The group also completed the questionnaires three times in the study period, at the same time with the test group and will receive a training book on spiritual education (including topics in the training sessions) at the end of the study. The dates for completing the questionnaire will be communicated to each group by telephone call..</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only part of the information, such as information on the main outcome or the like, can be shared

When:
Start the access period 6 months after publishing the results

To whom:
Data for researchers and people who are engaged in treatment can apply for them

Conditions:
Data for researchers and people who are engaged in treatment can apply for them

Where to obtain:
by Email atefedonyadide@yahoo.com

How to obtain:
by Email atefedonyadide@yahoo.com

Comments:
6 months after publishing the results</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyede Batool Hasanpoor-Azghady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing &amp; Midwifery., Tehran Town,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1907755551</zip>
        <telephone>+98 21 2286 0021</telephone>
        <email>hasanpoor.sb@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyede Batool Hasanpoor-Azghady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing &amp; Midwifery., Tehran Town,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1907755551</zip>
        <telephone>+98 21 2286 0021</telephone>
        <email>hasanpoor.sb@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female infertility approved by a gynecologist- First marriage of each of the couples-Age of 49-18 years - Non-infertility-related diseases Passed at least one year after an infertility diagnosis. Non-use of drugs and drugs related to mental disorders -Having at least a reading and writing literacy -The lack of education of each of the couples in the fields of theology -The lack of participation of each of the couples in courses or workshops seminary spiritual - religious Having a Shi'i religion -- Not having an adopted - Lack of something bad happening over the last 6 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>- An unpleasant incident during the research- Getting any psychological treatment before or during the study  - Childbirth or adoption during study- Getting out of the process of treating infertility- Not attending more than two training sessions</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>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The test group will participate in a group for 6 weeks in 6 sessions. Each session will run 90 minutes. The number of people in each training group will be six to eight. The two sessions of the six sessions that will be held in the third and sixth weeks will be the subject of theoretical knowledge in the areas of spirituality and religion that will be the main responsibility of the education that the researcher will attend in these two sessions, Training will follow the recommendations of the expert. The tool is used in group video projector (Powerpoint) and whiteboard meetings. The contents of the training sessions will be held at office hours and at the Infertility Center. Each training session is held in the form of a lecture and a question and answer to questions on previously defined topics in the booklet. In the last fifteen minutes, a summary of the contents will be done with the help of research units and the contents of each session will be provided to the test group. The content of the meetings is marked with details in Table (1). Trainings will be provided by the researcher. It should be noted that the researcher will participate in workshops on spiritual training for proper intervention. The test group three times: Before the intervention, at the end of the last training session and eight weeks after the completion of the training sessions, the Lazarus coping strategies questionnaire will be completed.  The content of the meetings is specified in the table (1) with details. Trainings will be provided by the researcher. It should be noted that the researcher will participate in workshops on spiritual training for proper intervention. The test group will complete the Lazarus coping strategies questionnaire three times before the intervention, at the end of the last training session and eight weeks after the completion of the training sessions. Discussion 1: Introduction of the researcher and reestablishment of goals, familiarity with the research units, discussion On the dimensions of human existence, especially its spiritual dimension and the needs of each dimension. Session 2: The importance of self-consciousness in the spiritual dimension, talking about the characteristics of the spiritual person, encouraging the patient to reveal the ideas and spiritual experiences themselves. Session 3: Talking about the meaning of life and methods of meaningfulness to life, encouraging research units to positively impart life experiences. Session 4: Methods for raising the religious and spiritual dimension: Encouraging the patient to participate in spiritual-religious programs, going to religious places, joining spiritual groups, assigning time to keep up with God. Session 5: Encourage the patient to use appropriate coping strategies such as trust, patience, forgiveness and the effects of mentioning God. Session 6: Problem-Solving Problem with Spiritual Approach, Completion of Lazarus Coping Strategies Questionnaire by Research Units                                              Control group: The health care center will receive the Infertility Center. The group also completed the questionnaires three times in the study period, at the same time with the test group and will receive a training book on spiritual education (including topics in the training sessions) at the end of the study. The dates for completing the questionnaire will be communicated to each group by telephone call.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The difference or non-difference of Problem- focus coping strategies includes: seeking social support, accepting responsibility, planful problem solving and positive reappraisal, and the Emotion-focus coping strategies includes: confronting, distancing, self-controlling and escape-avoidance. Timepoint: Before the intervention, at the end of the last training session and eight weeks after the completion of the training sessions. Method of measurement: Lazarus coping methods questionnaire.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-28</approval_date>
        <contact_name>Ethics Committees of Iran University of Medical Sciences</contact_name>
        <contact_address>Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
