<?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>IRCT20180621040184N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-07</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of body massage on the attachment behaviors of premature Infants' mothers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of body massage on the premature Infants' mothers' attachment behaviors in the Neonatal ICU of Shahid Sadoughi  and Afshar Yazd Hospitals</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32067</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Blinding description: Two researchers who assess the attachment behaviors of mothers in both control and test groups are not aware of the goals and method of the plan. At the morning shifts, when the mother presents to the infant's bedside to feed her infant with milk or interact with her baby, They observe the attachment behaviors of the mother without the mother awareness for 15 minutes then note it on the related checklist.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mothers of  preterm infants.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: To do massage, the hands are washed in accordance with the WHO Handbook of Hygiene provided to the mothers, and after drying hands, rubbing several times to warming hands using some palm oil, massage are done (sweet almond oil is used for all samples from a commercial brand called FADAK). Massage technique (field technique) consisted of three 5-minute steps and lasted a total of 15 minutes are applied. In the first and third stages, the baby is placed in the abdomen and massage is done as follows: 1- Upper head to neck and vice versa, 2- From neck to shoulders and vice versa, 3- From top to back and vice versa, 4- From shoulders to hand, then in reverse direction in both hands, 5- From thigh to ankle and foot then back in both legs. Massage is performed in each of the areas mentioned in 12 seconds. In the second stage, the baby is placed in an open arched position, and the inactive movements of the flexion and extension of the arms and legs separately, both legs together, in 5 stages of a minute, each containing 6 steps of 10 seconds , is done. In the test group, in addition to receiving regular care, each mother carries out massage for her baby for 24 hours, once daily for 30 to 40 minutes after lactation, when the baby is pricked for 5 days. Intervention 2: Control group: In the control group, mothers and infants receive only the usual care of the department. This care includes: doctor's examination, daily baby weighing, medication, serum therapy, teaching breastfeeding to mothers, controlling the absorption and discharge of the baby, and evaluating the correct nutrition of the baby. Attachment assessment is performed on the first, third and fifth day when the mother is on the infant's bedside to feed her baby, being with or interact with her baby.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Kargar Shooroki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghadir Alley 18, Ghadir Street,Imam Street</address>
        <city>Meybod</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8964155345</zip>
        <telephone>+98 35 3234 0365</telephone>
        <email>z.kargar@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Kargar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghadir Alley 18, Ghadir Street,Imam Street</address>
        <city>Meybod</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8964155345</zip>
        <telephone>+98 35 3234 0365</telephone>
        <email>kargarz38@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of birth is from 34 weeks of pregnancy to 37 weeks of pregnancy
Nutrition with breast milk or milk powder
3 to 5 days from the birth of the baby
Mother should be Persian speaker
Mother must be literate at least to read and write
Mother should have a wanted, single pregnancy</inclusion_criteria>
      <agemin>3 days</agemin>
      <agemax>7 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Neonates with cardio-pulmonary and neuro-muscular disorders require intubation and care at level three
Infant born by IVF method or born after several years of infertility
Mothers dissatisfaction with the sex of the baby
Having a history of high-risk behaviors in mother or spouse (prison record, drug addiction, alcohol use)
Maternal addiction to drugs and alcohol
Use of antidepressants by mother
Mother's education in psychology and counseling</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: To do massage, the hands are washed in accordance with the WHO Handbook of Hygiene provided to the mothers, and after drying hands, rubbing several times to warming hands using some palm oil, massage are done (sweet almond oil is used for all samples from a commercial brand called FADAK). Massage technique (field technique) consisted of three 5-minute steps and lasted a total of 15 minutes are applied. In the first and third stages, the baby is placed in the abdomen and massage is done as follows: 1- Upper head to neck and vice versa, 2- From neck to shoulders and vice versa, 3- From top to back and vice versa, 4- From shoulders to hand, then in reverse direction in both hands, 5- From thigh to ankle and foot then back in both legs. Massage is performed in each of the areas mentioned in 12 seconds. In the second stage, the baby is placed in an open arched position, and the inactive movements of the flexion and extension of the arms and legs separately, both legs together, in 5 stages of a minute, each containing 6 steps of 10 seconds , is done. In the test group, in addition to receiving regular care, each mother carries out massage for her baby for 24 hours, once daily for 30 to 40 minutes after lactation, when the baby is pricked for 5 days.</i_keyword>
      <i_keyword>Control group: In the control group, mothers and infants receive only the usual care of the department. This care includes: doctor's examination, daily baby weighing, medication, serum therapy, teaching breastfeeding to mothers, controlling the absorption and discharge of the baby, and evaluating the correct nutrition of the baby. Attachment assessment is performed on the first, third and fifth day when the mother is on the infant's bedside to feed her baby, being with or interact with her baby.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attachment. Timepoint: Before the intervention, the third day and the fifth day after the intervention. Method of measurement: Observation questionnaire on maternal attachment behaviors.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-26</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi of  University of Medical Sciences</contact_name>
        <contact_address>Ghadir Alley 18, Ghadir Street,Imam Street Mybod Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
