<?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>IRCT201201163250N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-12-07</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology, Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Yakson and Gentle Human Touch on preterm infants</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between Yakson and Gentle HumanTouch on behavioral states of preterm infants hospitalized in the neonatal intensive care units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3325</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>preterm infant.</hc_freetext>
      <i_freetext>Intervention 1: Yakson intervention:&#13;
1. After wearing a clean inner gown, the researcher washed her hands and arms thoroughly with antimicrobial agents for 3 min.&#13;
2. She warmed both of her hands using a radiant warmer until the temperature of the palms reached 93.2 8F (34.0 8C).&#13;
3. She relaxed both arms and the muscles of both shoulders for 1 min and breathed deeply to concentrate Ki energy on their palms.&#13;
4. She provided Yakson to preterm infants. Yakson lasted 15 min: hand resting (5 min), gentle caressing (5 min), and hand resting again (5 min). During the administration of Yakson, the palms and all fingers of the researcher constantly maintained close contact with the infants up to the limit that preterm infants did not feel pressure.&#13;
(1) Hand resting (5 min): while resting one hand on the chest and abdomen of a preterm infant&#13;
while supporting the back of the preterm infant with the other hand, the researcher concentrated on her resting hands and envisioned that a healthy Ki was passing to the preterm infant. At that time, the researcher breathed slowly to maintain a relaxed state.&#13;
(2) Gentle caressing (5 min): in the same hand position, the researcher repeated caressing and resting for 5 min; caressing (1 min) – resting (30 s) – caressing (1 min) – resting (30 s) – caressing (2min). The researcher caressed the infant’s chest and abdomen clockwise in a 1 cm diameter circular motion every 10 s.&#13;
(3) Hand resting (5 min): researcher followed the same hand resting procedure as described above. Intervention 2: GHT intervention:     &#13;
The Gentle Human Touch (GHT) protocol was as follows: Jay (1982) and Harrison et al. (2000).&#13;
1. After wearing a clean inner gown, the NICU nurses trained washed both hands and arms with antimicrobial agents for 3 min.&#13;
2. The NICU nurses trained warmed both of her hands using a radiant warmer until the temperature of the palms reached 93.2 8F.&#13;
3. For 15 min, the NICU nurses trained placed the fingertips of one hand above the eyebrow line with the palm touching the preterm infant’s crown while the other hand was rested on the lower abdomen of the infant encompassing the waist and the hip. Intervention 3: Control group: receive routine nursing 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Bahareh Bahman Bijari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Pediatrics, Afzali por hospital</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913911</zip>
        <telephone>+98 34 1322 2250</telephone>
        <email>bbbijari@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Bahareh Bahman Bijari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Pediatrics, Afzali por hospital</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913911</zip>
        <telephone>+98 34 1322 2250</telephone>
        <email>bbbijari@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: (1) a gestational age of 26–34 weeks at birth;(2) not having undergone surgery.   Exclusion criteria: (1) congenital anomalies; (2) Apgar score less than 6 at 5 min; (3 Lack of medical condition contraindicating the running of Yakson or GHT such as symptomatic sepsis.</inclusion_criteria>
      <agemin>26 years</agemin>
      <agemax>34 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Yakson intervention:&#13;
1. After wearing a clean inner gown, the researcher washed her hands and arms thoroughly with antimicrobial agents for 3 min.&#13;
2. She warmed both of her hands using a radiant warmer until the temperature of the palms reached 93.2 8F (34.0 8C).&#13;
3. She relaxed both arms and the muscles of both shoulders for 1 min and breathed deeply to concentrate Ki energy on their palms.&#13;
4. She provided Yakson to preterm infants. Yakson lasted 15 min: hand resting (5 min), gentle caressing (5 min), and hand resting again (5 min). During the administration of Yakson, the palms and all fingers of the researcher constantly maintained close contact with the infants up to the limit that preterm infants did not feel pressure.&#13;
(1) Hand resting (5 min): while resting one hand on the chest and abdomen of a preterm infant&#13;
while supporting the back of the preterm infant with the other hand, the researcher concentrated on her resting hands and envisioned that a healthy Ki was passing to the preterm infant. At that time, the researcher breathed slowly to maintain a relaxed state.&#13;
(2) Gentle caressing (5 min): in the same hand position, the researcher repeated caressing and resting for 5 min; caressing (1 min) – resting (30 s) – caressing (1 min) – resting (30 s) – caressing (2min). The researcher caressed the infant’s chest and abdomen clockwise in a 1 cm diameter circular motion every 10 s.&#13;
(3) Hand resting (5 min): researcher followed the same hand resting procedure as described above.</i_keyword>
      <i_keyword>GHT intervention:     &#13;
The Gentle Human Touch (GHT) protocol was as follows: Jay (1982) and Harrison et al. (2000).&#13;
1. After wearing a clean inner gown, the NICU nurses trained washed both hands and arms with antimicrobial agents for 3 min.&#13;
2. The NICU nurses trained warmed both of her hands using a radiant warmer until the temperature of the palms reached 93.2 8F.&#13;
3. For 15 min, the NICU nurses trained placed the fingertips of one hand above the eyebrow line with the palm touching the preterm infant’s crown while the other hand was rested on the lower abdomen of the infant encompassing the waist and the hip.</i_keyword>
      <i_keyword>Control group: receive routine nursing care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Behavioral state. Timepoint: 2 miniute befor intervention and 2 miniute after intervention. Method of measurement: Anderson Behavioral State Scale (ABSS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Harte rate. Timepoint: 2 miniute befor intervention and 2 miniute after intervention. Method of measurement: Spacelabs medica manitor.</sec_outcome>
      <sec_outcome>Arterial oxygen saturation. Timepoint: 2 miniute befor intervention and 2 miniute after intervention. Method of measurement: Spacelabs medica manitor.</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>Vice Chancellor for Research and Technology, Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-18</approval_date>
        <contact_name>Vice Chancellor for Research and Technology, Kerman University of Medical Sciences</contact_name>
        <contact_address>Jahad Blvd, Ebn Sina Avenue Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
