<?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>IRCT20230706058694N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-20</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of Chinese massage on pain in newborns</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Chinese massage on pain caused by gastric tube implantation in premature infants admitted to neonatal intensive care unit: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71219</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we will use the permutation block randomization method.
In this two-group clinical trial, the size of the blocks will be 4, 6, and 8 (in this method, the number of people assigned to each group in the blocks is equal). The randomization tool is one of the random sequence generation software (software for random allocation) such as Stata or R.
For concealment in the research, we use concealment allocation. By using opaque, sealed, numbered sequentially envelopes, in this method, each random sequence created is recorded on a card, and the cards inside the letter envelopes are They are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of the registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the allocation group of that participant will be revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Necessary intervention in infants is performed by an experienced nursing expert who is proficient in the hugo massage method in infants and has the relevant certificate. First, put on a clean gown and wash your hands for three minutes, and then warm your hands with a warmer to get the right temperature. Then he determines the place of massage. The massage place is between the two index fingers and the thumb, and its exact location is on the back of the hand, between the first and second metacarpal bones, in the middle of the second metacarpal bone in its axial direction. The best way to find Hugo's point is that Find the point where the thumb and index finger connect to each other at the bottom of the wrist and after finding this point, place your finger next to the bone of the index finger and about half an inch away from the beginning, and then after that Lean slightly towards your thumb. Another way to identify the exact location of Hugo's point is to stick two thumbs and index fingers together, so that a mass is formed between these two fingers. The middle of this mass is exactly the Hugo point. To perform this type of massage, first place your thumb or other finger exactly on that point and apply pressure to this point. Perform the massage in three times of one minute and with an interval of 30 seconds, 5 minutes before embedding. Oral-gastric tube and during its insertion is done by the nurse related to the baby. Intervention 2: Control group: The method of doing the work in the control group is that no massage will be done, and 2-3 minutes before inserting the gastric tube during the work and 30 seconds after, the pain score and behavioral responses will be measured using the PIPP tool. became .</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 "There is no further information".</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ayoub Panahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razm Avaran St., Shahid Yusuf Abroshan Alley</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931758473</zip>
        <telephone>+98 84 3333 2093</telephone>
        <email>panahi.a@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ayoub Panahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razm Avaran St., Shahid Yusuf Abroshan Alley</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931758473</zip>
        <telephone>+98 84 3333 2093</telephone>
        <email>panahi.a@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Infants with a gestational age of at least 28 weeks
absence of mother's addiction and use of drugs related to epilepsy and neurological disorders
willingness and consent of the mother to participate in the study
stable clinical and physiological condition of the infant
no mechanical ventilation
If the baby does not suffer from central nervous system damage
he should have an order to fix the nasogastric tube.
Failure to receive drugs that affect the physiological and behavioral state
not performing any painful procedure at least one hour before the intervention
Babies with a gestational age of up to 36 weeks and 6 days</inclusion_criteria>
      <agemin>7 days</agemin>
      <agemax>9 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Significant change in the stability of the hemodynamic state
drop in arterial blood oxygen to less than 85% for 2 minutes -
sudden death of the baby.
early discharge of the baby with the personal consent of the parents</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain due to trauma</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Necessary intervention in infants is performed by an experienced nursing expert who is proficient in the hugo massage method in infants and has the relevant certificate. First, put on a clean gown and wash your hands for three minutes, and then warm your hands with a warmer to get the right temperature. Then he determines the place of massage. The massage place is between the two index fingers and the thumb, and its exact location is on the back of the hand, between the first and second metacarpal bones, in the middle of the second metacarpal bone in its axial direction. The best way to find Hugo's point is that Find the point where the thumb and index finger connect to each other at the bottom of the wrist and after finding this point, place your finger next to the bone of the index finger and about half an inch away from the beginning, and then after that Lean slightly towards your thumb. Another way to identify the exact location of Hugo's point is to stick two thumbs and index fingers together, so that a mass is formed between these two fingers. The middle of this mass is exactly the Hugo point. To perform this type of massage, first place your thumb or other finger exactly on that point and apply pressure to this point. Perform the massage in three times of one minute and with an interval of 30 seconds, 5 minutes before embedding. Oral-gastric tube and during its insertion is done by the nurse related to the baby.</i_keyword>
      <i_keyword>Control group: The method of doing the work in the control group is that no massage will be done, and 2-3 minutes before inserting the gastric tube during the work and 30 seconds after, the pain score and behavioral responses will be measured using the PIPP tool. became .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention - during the intervention - up to 30 seconds after the intervention. Method of measurement: Using the Infant Pain Profile (PIPP).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Behavioral responses. Timepoint: Before the intervention - during the intervention - up to 30 seconds after the intervention. Method of measurement: PIPP tool.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-03</approval_date>
        <contact_name>Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Ahvaz, Academic City, Vice-Chancellor of Research and Technology of Jundishapur University of Medical Sciences and Health Care Services, ground floor ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
