<?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>IRCT20150731023423N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-24</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect Of Midwifery Counseling With  Spiritual Approach In Improving The Sleep Quality Of Pregnant Women</public_title>
      <acronym></acronym>
      <scientific_title>The Effect Of Midwifery Counseling With spiritual approach In Improving The  Sleep Quality Of Pregnant Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48051</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Convenience Sampling Method will Be Employed to Select The Eligible Mothers.They Will Be Allocated Into The Two Groups (Intervention and Control) Based On The Four Block Design. In This Way, Six Possible Blocks Will Be Assigned To Group A (Intervention) And Group B (Control). Then, The Number Of Blocks Will Be Selected From The Random Number Table Until The Study Sample Size Will Be Reached. To Ensure The Concealment of The Sequence of Enrollment, We  Will Be Used The Sequentially Numbered, Opaque Sealed Envelopes.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Sleep Quality. Condition 2: Severity Of Insomnia. Condition 3: Spiritual Sxperience.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The Intervention Group Will Be Received Counseling With Spiritual Approach At 20 Week Of Gestation. Spiritual Group Counseling Will Be Held In 8 Sessions, Twice Per A Week, Each Session For 45 To 60 Minutes.To Compile The Content Of The Sessions Bouleri's Book Has Been Used, Which Includes: Talking About The Concept Of Sleep, Sleep Quality, Changes In Sleep Patterns During Pregnancy.The Causes And Problems Of Insomnia. One's Attitude Towards Spiritual Issues, The Role Of God And Religion In Her Life. Sleep Health Education. Relaxation, Breathing Exercises With Focusing On Mentioning Allah And Repeating It 10 To 15 Times In A Day.To Emphasis On Faith In God, Trust, Forgiveness,  And Repentance In Relaxation And Controlling Of Insomnia Stimuli. Intervention 2: Control group: They Will Receive Routine Prenatal 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Dissatisfaction participants</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gavazang Road, Zanjan University Of Medical Sciences, Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515613191</zip>
        <telephone>+98 24 3345 7707</telephone>
        <email>midwifmoradi@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maleki Azam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gavazang Road, Zanjan University Of Medical Sciences, Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515613191</zip>
        <telephone>+98 24334206519</telephone>
        <email>Makekia@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gestational Age 20-16 weeks
The Desire To Participate In The Study
Getting More Than 5 Point Based On The Pittsburgh Sleep Quality Index
Getting Score Less Than 22  Based On The 28-Item General Health Questionnaire
Normal Pregnancy
Wanted Pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having A Medical And Obstetric Complication
Taking Sleeping Pills
Having A Known Mental Disease
Participate In A Spiritual-Oriented Training Program</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The Intervention Group Will Be Received Counseling With Spiritual Approach At 20 Week Of Gestation. Spiritual Group Counseling Will Be Held In 8 Sessions, Twice Per A Week, Each Session For 45 To 60 Minutes.To Compile The Content Of The Sessions Bouleri's Book Has Been Used, Which Includes: Talking About The Concept Of Sleep, Sleep Quality, Changes In Sleep Patterns During Pregnancy.The Causes And Problems Of Insomnia. One's Attitude Towards Spiritual Issues, The Role Of God And Religion In Her Life. Sleep Health Education. Relaxation, Breathing Exercises With Focusing On Mentioning Allah And Repeating It 10 To 15 Times In A Day.To Emphasis On Faith In God, Trust, Forgiveness,  And Repentance In Relaxation And Controlling Of Insomnia Stimuli.</i_keyword>
      <i_keyword>Control group: They Will Receive Routine Prenatal care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep Quality. Timepoint: Before The Intervention,  28 And 36 Weeks Of Gestation. Method of measurement: Pittsburgh Sleep Quality questionnaire.</prim_outcome>
      <prim_outcome>The Severity Of Insomnia. Timepoint: Before The Intervention,  28 And 36 Weeks Of Gestation. Method of measurement: Insomnia Severity Questionnaire.</prim_outcome>
      <prim_outcome>Spiritual Experience. Timepoint: Before The Intervention,  28 And 36 Weeks Of Gestation. Method of measurement: The Daily Spiritual Experience Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The severity of insomnia. Timepoint: Before the intervention, week 28 and week 36 of pregnancy. Method of measurement: ISI Sleep Disorders Index Questionnaire.</sec_outcome>
      <sec_outcome>Daily spiritual experiences. Timepoint: Before the intervention, week 28 and week 36 of pregnancy. Method of measurement: The scale of daily spiritual experiences (DSES).</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>2019-06-25</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>
