<?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>IRCT20111219008459N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-08</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of counseling on the infant’s Colic of anxious mothers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of counseling with behavioral approach on the infant’s Colic of anxious mothers : a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45949</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants would be allocated into two groups (receiving counseling and control), using a randomized block method with a block size of four and six, and the allocation ratio of 1: 1.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Infantile Colic. Condition 2: maternal anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For intervention group mothers, according to the behavioral psychology approach and regular desensitization technique, 8 counseling sessions will be held two days a week for 4 consecutive weeks.The intervention protocol is as follows:  Session 1: Teaching how to breastfeed and get extra air in the baby's stomach and training relaxation for mothers with infants with colic,  Session 2: Continuation of relaxation training for mothers with colic,  Session 3: Identifying the anxiety hierarchy of mothers with infants with colic (from severe to mild),  Session 4: Initiation of desensitization: clients will sit relaxed or lying down and will begin to visualize and deal with anxiety (from the least anxious to the most). The fifth, sixth, seventh and eighth sessions of desensitization continue until the person Minimize anxiety in the cases listed. Probiotic drops will be prescribed for both groups infants. Two weeks after the intervention, infants' colic questionnaires, postpartum anxiety and mother-infant attachment questionnaires will be completed again. Intervention 2: Control group: The control group will be taught how to breastfeed and get extra air in the baby's stomach individually, and their babies will also receive probiotic drops.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reyhaneh Montazeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of NURSING and Midwifery, South Shariaty Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5168743953</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>Midr.Montazeri@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shirin Hasanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing Midwifery, South Shariati Street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5168743953</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>shirinhasanpoor@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Primiparous women with 2 to 6 weeks infants
Anxiety Based on Postpartum Anxiety Questionnaire (PSAS)
Diagnosis of infant colic based on Wessel criteria and approved by pediatrician
Having at least intermediate Education
Exclusive Breastfeeding
Healthy term infant weighing at least 2500 grams and normal weight gain</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Twin
Use of all kinds of chemical and herbal remedies such as anti-flatulence to treat infant colic.
Congenital autoimmune disease or infant nutritional problems.
A history of mental illness requiring medication, including postpartum depression in previous deliveries (according to the individual).
The mother's anxiety as much as she needs medication.
Existence of mothers' drug abuse during pregnancy and in the postpartum period (according to the individual).
Mother's education in research topic from other sources.
Maternal formal education / training to reduce anxiety.
Mother's uncertainty about attending all counseling sessions.
Adverse events such as the death of loved ones or divorce and ... for the mother in the last 2 months.
Mother's use of antibiotics.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R10.83</hc_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Colic</hc_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For intervention group mothers, according to the behavioral psychology approach and regular desensitization technique, 8 counseling sessions will be held two days a week for 4 consecutive weeks.The intervention protocol is as follows:  Session 1: Teaching how to breastfeed and get extra air in the baby's stomach and training relaxation for mothers with infants with colic,  Session 2: Continuation of relaxation training for mothers with colic,  Session 3: Identifying the anxiety hierarchy of mothers with infants with colic (from severe to mild),  Session 4: Initiation of desensitization: clients will sit relaxed or lying down and will begin to visualize and deal with anxiety (from the least anxious to the most). The fifth, sixth, seventh and eighth sessions of desensitization continue until the person Minimize anxiety in the cases listed. Probiotic drops will be prescribed for both groups infants. Two weeks after the intervention, infants' colic questionnaires, postpartum anxiety and mother-infant attachment questionnaires will be completed again.</i_keyword>
      <i_keyword>Control group: The control group will be taught how to breastfeed and get extra air in the baby's stomach individually, and their babies will also receive probiotic drops.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Infantile colic. Timepoint: Measurement of infant colic score before the intervention and 2 weeks after the intervention. Method of measurement: Infantile Colic scale (ICS).</prim_outcome>
      <prim_outcome>Maternal anxiety. Timepoint: Measurement of maternal anxiety score before the intervention and 2 weeks after intervention. Method of measurement: Postpartum Specific Anxiety scale (PSAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal Postnatal Attachment. Timepoint: Measuring mother-infant attachment score before and two weeks after intervention. Method of measurement: Maternal Postnatal Attachment scale (MPAs).</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-07</approval_date>
        <contact_name>Ethics Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>South Shariati Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
