<?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>IRCT20200130046304N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-13</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Yaxon Touch on Pain Control and Weight gain in Premature Infants Hospitalized in Neonatal Intensive Care Unit</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Yaxon Touch on Pain Control and Weight gain in Premature Infants Hospitalized in Neonatal Intensive Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45723</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>Premature infants.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The Jackson protocol used in this study combines the following procedures: 1. After wearing a clean gauze, your hands and arms will be completely covered with antimicrobial detergents for 3 minutes. Warm up with Warmer to reach 34 degrees Celsius.3-The researcher presses both arms and muscles of both shoulders for one minute to concentrate the vital energy of the palms.4-The researcher touches Jackson Premature baby supplies. Jackson's touch lasts for 15 minutes: 5 minutes of hand rest and 5 minutes of gentle stroking and 5 minutes of rest again. The researcher's fingers will be in constant touch with the baby so that the baby will not feel pressure.1-Hand Rest -5 Minutes: While one hand rests on the chest and abdomen of the preterm infant, the back of the preterm infant is supported with the other, the researcher concentrates energy on her resting hands with deep breaths During this time, the researcher slowly breathed in to keep calm2-gentle stroke (5 minutes): Researcher repeated hand and stroke for 5 minutes in the same position: stroking (1 minute) -setting (30 seconds) -setting (1 minute) -setting (30 seconds) -setting (2 minutes). The abdomen and chest researcher pats the baby clockwise in a circular motion 1 cm in diameter every 10 seconds.3-Resting the hand (5 minutes): The researcher rests the hand as if The above described will follow. The Jackson touch will be performed by the researcher once each morning (11-9am) and for 5 consecutive days. Intervention 2: Control group: Routine work is done.</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 Confidentiality of patient information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nastaran Semnani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alavi</address>
        <city>Gonbad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>49717-83897</zip>
        <telephone>+98 17 3322 3545</telephone>
        <email>nastaran.semnani45@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nastaran Semnani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alavi</address>
        <city>Gonbad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>49717-83897</zip>
        <telephone>+98 17 3322 3545</telephone>
        <email>nastaran.semnani45@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- Premature infants 32-37 weeks hospitalized in Taleghani Pediatric Hospital, Gonbad.
- infants not connected to the ventilator.
Children whose legal guardian has given written consent to participate in the study
The baby is not infected with other chronic diseases that the study protocol causes further damage to the baby
Infants over seven days old.</inclusion_criteria>
      <agemin>7 days</agemin>
      <agemax>1 month</agemax>
      <gender>Both</gender>
      <exclusion_criteria>-Family's willingness to research for whatever reason.
Baby death
Early discharge of the baby
Changes in any general condition of the baby
Need for surgery.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>p07.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Preterm [premature] newborn [other]</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: The Jackson protocol used in this study combines the following procedures: 1. After wearing a clean gauze, your hands and arms will be completely covered with antimicrobial detergents for 3 minutes. Warm up with Warmer to reach 34 degrees Celsius.3-The researcher presses both arms and muscles of both shoulders for one minute to concentrate the vital energy of the palms.4-The researcher touches Jackson Premature baby supplies. Jackson's touch lasts for 15 minutes: 5 minutes of hand rest and 5 minutes of gentle stroking and 5 minutes of rest again. The researcher's fingers will be in constant touch with the baby so that the baby will not feel pressure.1-Hand Rest -5 Minutes: While one hand rests on the chest and abdomen of the preterm infant, the back of the preterm infant is supported with the other, the researcher concentrates energy on her resting hands with deep breaths During this time, the researcher slowly breathed in to keep calm2-gentle stroke (5 minutes): Researcher repeated hand and stroke for 5 minutes in the same position: stroking (1 minute) -setting (30 seconds) -setting (1 minute) -setting (30 seconds) -setting (2 minutes). The abdomen and chest researcher pats the baby clockwise in a circular motion 1 cm in diameter every 10 seconds.3-Resting the hand (5 minutes): The researcher rests the hand as if The above described will follow. The Jackson touch will be performed by the researcher once each morning (11-9am) and for 5 consecutive days</i_keyword>
      <i_keyword>Control group: Routine work is done.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neonatal pain control. Timepoint: 5 day. Method of measurement: The tool used in this study to record the information will be a checklist for recording the outcomes of the NIPS pain management questionnaire.</prim_outcome>
      <prim_outcome>Weight gain in newborns. Timepoint: 5day. Method of measurement: In both groups, the baby's weight will be measured using the scale-LAIKA- with a measurement accuracy of 5 grams.</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>Azad University of Abad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-06</approval_date>
        <contact_name>Ethics committee of chalos University of Medical Sciences</contact_name>
        <contact_address>University Boulevard, Golestan, Aliabad, Iran Ali abad Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
