<?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>IRCT20170116031972N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-27</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparative effect of maternal holding and massage on heel blood sampling, physiological responses, and pain in neonates</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effect of maternal holding and massage on heel blood sampling, physiological responses, and pain in neonates</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29480</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain, crying time due to blood sampling, physiological symptoms (heart rate, respiration rate, and oxygen saturation).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the mother's embrace group, the infants are placed in their mother's arms two minutes before, during and at least 15 seconds after blood sampling, with the difference that they are not breastfed. All infants will be awake when applying this procedure. Their mothers sit on the comfort seat and will be allowed to cuddle their babies when they cry during blood sampling. Intervention 2: Intervention group: In the massage group before blood sampling, the researcher gently massages the baby's foot from the fingertips to the middle of the thigh, massage with the effleurage technique will be done with the thumb of one hand for 2 minutes, and the place of massages will be covered for one minute with a warm towel. Massage is used to move the contents of the superficial lymph vessels and blood vessels to facilitate blood circulation as well as to manipulate tissue fluids. The effleurage is done through the flow direction of venous to the heart. Massage is soft, smooth, uniform and constant, and always from the point of return of the vessels (distal) to the primary areas (proximal). Intervention 3: Control group: In the control group, the routine procedure of the health center (sleeping on the bed during blood sampling) is performed. It should be noted that all blood sampling is carried out under the same conditions with the same facilities and by one of the health center personnel.</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 still no plan to develop a program for sharing the data. According to the above sampling data time, the study will be completed by that time.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefe Roshanray</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hormozgan, Bandar Abbas, Tohid Town</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 76 3366 6240</telephone>
        <email>Roshanray375@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masood Rayani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman,</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>m_rayani@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy full-term infants (38 to 42 weeks)
Birth weight 2500-4000 grams
Apgar more than 7 at birth.
Stability in terms of clinical condition
infants at 4th to 6th birthday who to screen for hypothyroidism.</inclusion_criteria>
      <agemin>266 days</agemin>
      <agemax>294 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any congenital and chromosomal anomalies
Having painful interventions such as circumcision and getting the peripheral vein before referring to the health center</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the mother's embrace group, the infants are placed in their mother's arms two minutes before, during and at least 15 seconds after blood sampling, with the difference that they are not breastfed. All infants will be awake when applying this procedure. Their mothers sit on the comfort seat and will be allowed to cuddle their babies when they cry during blood sampling.</i_keyword>
      <i_keyword>Intervention group: In the massage group before blood sampling, the researcher gently massages the baby's foot from the fingertips to the middle of the thigh, massage with the effleurage technique will be done with the thumb of one hand for 2 minutes, and the place of massages will be covered for one minute with a warm towel. Massage is used to move the contents of the superficial lymph vessels and blood vessels to facilitate blood circulation as well as to manipulate tissue fluids. The effleurage is done through the flow direction of venous to the heart. Massage is soft, smooth, uniform and constant, and always from the point of return of the vessels (distal) to the primary areas (proximal).</i_keyword>
      <i_keyword>Control group: In the control group, the routine procedure of the health center (sleeping on the bed during blood sampling) is performed. It should be noted that all blood sampling is carried out under the same conditions with the same facilities and by one of the health center personnel.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The initial outcome could be an increase or decrease in the pain score. Timepoint: The pain score measurement is done at the beginning of the study (before the intervention), immediately after blood sampling, and 5 minutes after blood sampling. Method of measurement: Neonatal Infant Pain Scale (NIPS).</prim_outcome>
      <prim_outcome>The initial outcome could be an increase or decrease in the baby's crying time. Timepoint: The time interval for the measurement of the crying time is after blood sampling. Method of measurement: Stop watch.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The initial outcome could be an increase or decrease in the heart rate. Timepoint: Heart rate measurement as a secondary outcome is done at the beginning of the study (before the intervention), immediately after blood sampling, and 5 minutes after blood sampling. Method of measurement: Pulse Oximeter.</sec_outcome>
      <sec_outcome>The initial outcome could be an increase or decrease in SPO2. Timepoint: SPO2 measurement as a secondary outcome is​ done at the beginning of the study (before the intervention), immediately after blood sampling, and 5 minutes after blood sampling. Method of measurement: Pulse Oximeter.</sec_outcome>
      <sec_outcome>The initial outcome could be an increase or decrease in respiratory rate. Timepoint: Respiratory rate measurement as a secondary outcome is done at the beginning of the study (before the intervention), immediately after blood sampling, and 5 minutes after blood sampling. Method of measurement: Pulse Oximeter.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-04</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Ebnesina St،Jahad Blvd، Somaye Crossroad، Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
