<?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>IRCT20200107046044N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-26</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of cold spray and acupressure on pain during venipuncture</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of cold spray and acupressure on pain during venipuncture in hospitalized children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-03-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>123</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81400</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block random assignment will be done in such a way that according to the number of study groups (three groups) consisting of intervention 1 (Cold spray), intervention 2 (Acupressure) and control and calculated based on the factorial law, i.e. 3!= 3×2×1= 6, all the possible arrangement modes of people will be compiled based on the table below, considering A for intervention group 1 (Cold spray), B for intervention group 2 (Acupressure) and C for control group:
   1              2              3              4             5               6
CBA	CAB	BCA	BAC	ACB	ABC
Then, since the estimated sample size was 123 people, in each block, three samples, each representative of a study group and their arrangement order was also different, from these blocks, placement sampling will be done. After the study objectives are fully explained, eligible research samples will be selected and, based on the time priority of referral, each of them will be assigned a code. By matching that number with the block random allocation list, the patients participating in the study will be assigned to one of the intervention 1 (Cold spray), intervention 2 (Acupressure), and control groups. This process will continue until the estimated sample size is completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain during venipuncture in hospitalized children.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cold spray: In this group, before performing the intravenous intervention, cold spray will be applied for 5 seconds at a distance of 15 cm to an area of ​​approximately 5 cm2 at the surgical site. After securing the tourniquet and then disinfecting the skin for 60 seconds, the researcher will perform the intravenous injection and, in the meantime, the patient's pain will be recorded and measured using a visual analog scale. Intervention 2: Intervention group 2: Acupressure: Acupressure will be performed on the P6 point. The P6 point is located on the inner side of the arm and in the cavity between the bones of the forearm, 3 finger widths above the wrist crease. Before applying acupressure, the nurse will first wash the hands and then warm them up to normal body temperature. Then, a massage will be performed from the fingertips to the elbow. For the purpose of the intervention, pressure on the mentioned point will be applied with a force of 3 to 5 kg on both sides in each hand for 3 minutes with the thumb, 3 minutes at each point and 2 minutes of rest, in a circular motion and 2 revolutions per second, so that the patient feels a tingling sensation and mild numbness in his hand. Then, the researcher will insert an angiocatheter (blue, size 22) in the brachial area for all patients while they are sitting on a comfortable chair, and during this time, the patient's pain will be recorded and measured using a visual analog scale. Each patient will have 1 acupressure session, and each acupressure session will last 10 minutes. Intervention 3: Control group: non-intervention: There will be no intervention in this group.</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>MohammadSajjad Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran</address>
        <city>Bandar-e-Mahshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6354169401</zip>
        <telephone>+98 61 5242 1065</telephone>
        <email>sajjad.mousavi2512@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>MohammadSajjad Mousavi محمدسجاد موسوی</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alfa 246 B, Golestan 1, Shahrak-e Mamku, Bandar-e-Mahshahr, Khuzestan, Islamic Republic of Iran</address>
        <city>Bandar-e-Mahshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6354169401</zip>
        <telephone>+98 61 5242 1065</telephone>
        <email>sajjad.mousavi2512@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to communicate and respond to visual pain scales
Being 6-12 years old
Consent to participate in the study and signing the informed consent form
No previous training or participation in studies similar to the current research in the past 6 months</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
Unsuccessful venipuncture or need for repeat venipuncture
Receiving another painful intervention at the same time as the angiocath
Taking sleeping pills, anti-anxiety medications, and antidepressants before the intervention
Taking painkillers within 3 hours before or during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other acute postprocedural pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cold spray: In this group, before performing the intravenous intervention, cold spray will be applied for 5 seconds at a distance of 15 cm to an area of ​​approximately 5 cm2 at the surgical site. After securing the tourniquet and then disinfecting the skin for 60 seconds, the researcher will perform the intravenous injection and, in the meantime, the patient's pain will be recorded and measured using a visual analog scale.</i_keyword>
      <i_keyword>Intervention group 2: Acupressure: Acupressure will be performed on the P6 point. The P6 point is located on the inner side of the arm and in the cavity between the bones of the forearm, 3 finger widths above the wrist crease. Before applying acupressure, the nurse will first wash the hands and then warm them up to normal body temperature. Then, a massage will be performed from the fingertips to the elbow. For the purpose of the intervention, pressure on the mentioned point will be applied with a force of 3 to 5 kg on both sides in each hand for 3 minutes with the thumb, 3 minutes at each point and 2 minutes of rest, in a circular motion and 2 revolutions per second, so that the patient feels a tingling sensation and mild numbness in his hand. Then, the researcher will insert an angiocatheter (blue, size 22) in the brachial area for all patients while they are sitting on a comfortable chair, and during this time, the patient's pain will be recorded and measured using a visual analog scale. Each patient will have 1 acupressure session, and each acupressure session will last 10 minutes.</i_keyword>
      <i_keyword>Control group: non-intervention: There will be no intervention in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score based on Visual Analogue Scale. Timepoint: Severity of pain before, during and after the intervention. Method of measurement: Visual Analogue Scale.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-08</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
