<?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>IRCT20110420006243N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-16</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>effect of massage on neonatal jaundice</public_title>
      <acronym></acronym>
      <scientific_title>effect of massage on neonatal hyperbilirubinemia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67283</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In the control group, massage is performed without any purpose in addition to phototherapy, which made the participant unaware of the type of participation in the project. The massage is performed once by a doctor and once by the mother, which causes the researcher to be unaware. A data analyst also has no knowledge of the plan.
In the test group, targeted massage is performed with a special method in addition to phototherapy.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hyperbilirubinemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group :The intervention group is the group that, in addition to receiving phototherapy, received massage in this group. The massage is done with bare hands without any substance. The massage method is sub-designed: first the hands are washed and dried. The hands warm up the hands and bring them closer to the baby's body temperature. First, we start the massage from the face area and the thumb pad area around the eyes and cheeks with a very calm and low pressure, this work continues in the same way until the chest area. will continue. Then, the massage of the upper and lower limbs continues with a little more pressure than the previous areas. Finally, the baby's back is covered with the pads of the thumbs from the neck to the baby's buttocks. The massage method is the same for all the babies in the intervention group. Intervention 2: Control group: The control group in this study includes babies who only received phototherapy and no intervention was done for them.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After the design, the data is collected in an Excel file and archived after the publication of the article and analysis

When:
6 months after the project

To whom:
Pediatrician professors of universities

Conditions:
The data can be used for university teaching or to validate the plan or meta-analysis for the research subject if the legal conditions of the person are met.

Where to obtain:
To the mentioned address and the person responsible for the plan

How to obtain:
Writing a written letter and the reason for requesting the data after approval by the responsible person and with her decision

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shiva Rafati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ُShahada Square, Montazeri St., Block 5, Unit 5</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1714716653</zip>
        <telephone>+98 21 8896 9437</telephone>
        <email>dr.shrafati@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shiva Rafati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 5, Plate 5, Montazeri Street, Shahada Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1714716653</zip>
        <telephone>+98 21 8896 9437</telephone>
        <email>dr.shrafati@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>hyperbilirubinemia more than 12 mg/dl
weight between 2/5-4 kg
gestational age more than 37</inclusion_criteria>
      <agemin>3 days</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Babies less than 48 hours
A baby who is dehydration, does not feed well, is lethargic.
A baby with sepsis, seizures, hypoglycemia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P59.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Neonatal jaundice, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group :The intervention group is the group that, in addition to receiving phototherapy, received massage in this group. The massage is done with bare hands without any substance. The massage method is sub-designed: first the hands are washed and dried. The hands warm up the hands and bring them closer to the baby's body temperature. First, we start the massage from the face area and the thumb pad area around the eyes and cheeks with a very calm and low pressure, this work continues in the same way until the chest area. will continue. Then, the massage of the upper and lower limbs continues with a little more pressure than the previous areas. Finally, the baby's back is covered with the pads of the thumbs from the neck to the baby's buttocks. The massage method is the same for all the babies in the intervention group.</i_keyword>
      <i_keyword>Control group: The control group in this study includes babies who only received phototherapy and no intervention was done for them</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The amount of total bilirubin on different days. Timepoint: 1) Measurement of bilirubin in the newborn's blood upon entering the study, then on the first, second, and third days after the intervention. Method of measurement: by laboratory by photometric means using 2 and 4 dichloroaniline.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Comparison of the average weight of hospitalized infants in the control and intervention groups. Timepoint: When the baby enters the plan and on the first, second and third days after the intervention. Method of measurement: by means of a digital scale and under the same conditions.</sec_outcome>
      <sec_outcome>Comparison of infant stool frequency in the control and intervention groups. Timepoint: per day. Method of measurement: Number of diapers changed per day.</sec_outcome>
      <sec_outcome>Comparison of hospitalization time of infants in two control and intervention groups. Timepoint: Record the number of days of hospitalization. Method of measurement: With the help of the date of arrival and departure.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-08</approval_date>
        <contact_name>ethics committee of shahed university of medical sciences</contact_name>
        <contact_address>Tehran, Shahid Montazeri Street, Memarian Block, Block 5, Unit 5 tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
