<?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>IRCT20210801052045N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-08</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of educational intervention with mobile health technology and based on the theory of planned behavior on sleep quality, anxiety and perceived stress caused by the Covid-19 pandemic in pregnant women referred to urban health centers.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of educational intervention with mobile health technology and based on the theory of planned behavior on sleep quality, anxiety and perceived stress caused by the Covid-19 pandemic in pregnant women referred to urban health centers.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57860</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Training in this study is mobile health method and based on the theory of planned behavior, Randomization description: The research units will be randomly assigned to the intervention or control group using quadruple permutation blocks.
In this way, the first six possible modes of blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB) are listed and each block will be assigned a number from one to six. Then, a number between one and six will be randomly selected using a table of random numbers, and then people will be assigned to the test group (A) and control (B) based on the block corresponding to the selected number. This will continue until the sample size is complete.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Sleep quality. Condition 2: Corona stress. Condition 3: Corona anxiety. Condition 4: Behavior-based education.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Tashkia is an intervention group in WhatsApp software. 5 sessions of educational intervention in 2 sessions per week, each session for half an hour in the form of video and audio with pdf sessions. Educational materials based on the latest instructions of the Department of Maternal and Newborn Health of the Ministry of Health. Intervention 2: Control group: Control group: Form a control group in WhatsApp software. Only PDF tutorials are included in this group and also three questionnaires to complete.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Rostamikia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>57. beheshti5.5</address>
        <city>Torbatehedariyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9543113689</zip>
        <telephone>+98 51 5224 1954</telephone>
        <email>z.rostamikia72@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Asian Roadside - University Campus-Gonabad</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>000000000000000</zip>
        <telephone>+98 51 5722 0575</telephone>
        <email>faribaaskari10@yahoo.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gestational age is more than 12 weeks (at the same time as the beginning of the 12th week of pregnancy and up to 2 months after delivery, women suffer from sleep problems and poor sleep quality.)
Mothers aged 15-45 years
Ability to read and write
No complications and diseases during pregnancy, including preeclampsia, eclampsia, gestational diabetes, and hydramnios
No experience of a stressful event other than Covid-19 disease during the past 6 months
Unemployment of the pregnant mother in the hospital and unemployment in the night shift (due to the effect on sleep disorders)
No mental or physical illness
No smoking, drugs, and sleeping pills
No history of infertility
Pregnancy of a pregnant mother with Covid-19 disease now and in the past
Having the consent to enter the study
Having a WhatsApp messenger or the possibility of installing this software on a mobile phone</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Incidence of acute mental and physical illness
Premature rupture of membranes and preterm delivery
Abnormal fetal presentation
Pregnant mother with Covid-19</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_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>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Tashkia is an intervention group in WhatsApp software. 5 sessions of educational intervention in 2 sessions per week, each session for half an hour in the form of video and audio with pdf sessions. Educational materials based on the latest instructions of the Department of Maternal and Newborn Health of the Ministry of Health</i_keyword>
      <i_keyword>Control group: Control group: Form a control group in WhatsApp software. Only PDF tutorials are included in this group and also three questionnaires to complete</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleap quality. Timepoint: Before intervention, immediately after intervention, 1 month after intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</prim_outcome>
      <prim_outcome>Corona stress. Timepoint: Before intervention, immediately after intervention, 1 month after intervention. Method of measurement: Corona-related stress scale questionnaire.</prim_outcome>
      <prim_outcome>Corona Stress Scale: CSS. Timepoint: Before intervention, immediately after intervention, 1 month after intervention. Method of measurement: Corona Disease Anxiety Scale)CDAS).</prim_outcome>
      <prim_outcome>Training based on the theory of planned behavior. Timepoint: Before intervention, immediately after intervention, 1 month after intervention. Method of measurement: Researcher-made questionnaire on the theory of planned behavior.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-13</approval_date>
        <contact_name>Ethics Committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>57.beheshti5.5, beheshti Torbateheydariyeh Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
