<?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>IRCT201406057844N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-11-19</date_registration>
      <primary_sponsor>Vice chancellor for research, Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Evaporative spray effect on reducing injection pain in children</public_title>
      <acronym></acronym>
      <scientific_title>Study of effectiveness of evaporative spray on intravenous catheterization pain in  Imam Reza Hospital in Sirjan 2014</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8294</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Children hospitalized in Imam Reza Hospital in Sirjan.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Researcher prior to venipuncture to children and their parents participated in intervention group, branoll and supplies for venipuncture showed and describeto the about how to open up and fix IV. In addition to this equipment, evaporative spray in test group was added, and the children and their families was explained that the purpose of using the spray is only to reduce pain. Evaporative spray used in this study is freeze spray product in Italy, the exclusive representative of the company of modern medicine is expensive equipment. Vapocoolant sprays are rapid-acting alternatives to topical anesthetics. The material used in spray is isopropyl alcohol. They provide transient anesthesia via evaporation-induced skin cooling, which reduces pain. Evaporative spray after being sprayed,  destroys the skin hot  and with disabling pain receptors can cause temporary numbness. The vapocoolant spray that we studied is a nonflammable, nontoxic and ozone-friendly spray. It is easy to apply, is less expensive than alternatives, works instantaneously, does not require a needle or needle-like device and is relatively innocuous.  Side effects include rare allergic reactions and minor temporary skin changes. Unfortunately, skin changes may become permanent if the topical spray exceeds 10 seconds because severe local hypothermia may cause the death of local cells Area of  the venipuncture was bent elbow. In the test group before venipuncture, evaporative spray was used,It was to be sprayed at room temperature by the researcher from a distance of25-30 cm for 5-10 seconds until the white and pale skin would have and Because of the short-acting, 40-30 seconds after the vessel began taking by special nurse.In addition, the intervention group before venipuncture first spray was and after the area was Sterilization. To reduce the effect of confounding factors, the sterilization procedures and venipuncture was performed completely identical in intervention group. Practice of opening a vein in all  of the sample, in intervention group were performed by nurses with pediatric experience. Behavioral pain scale in children during procedures in intervention group were observed and recorded by the nurse researcher. After injection pain in children by means of numerical pain was assessed by the children themselves. Intervention 2: Control group: In the control group used of placebo  spray that Similar to the form used in the intervention group but with normal Saylyn . How to use a placebo spray Practice of opening vein and the instruments and area of  the venipuncture in Control group were similar to intervention group. In the Control group before venipuncture, placebo  spray was used,It was to be sprayed at room temperature by the researcher from a distance of25-30 cm for 5-10 seconds, 40-30 seconds after the vessel began taking by special nurse.In addition, the Control group before venipuncture first spray was and after the area was Sterilization. Practice of opening a vein in all  of the sample, in Control group were performed by nurses with pediatric experience. Behavioral pain scale in children during procedures in Control group were observed and recorded by the nurse researcher. After injection pain in children by means of numerical pain was assessed by the children themselves.</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>Masood Rayani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Chamber of Presiden, second floor,School of Nursing and Midwifery, Haftbagh, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۶۱۸۷۴۷۶۵۳</zip>
        <telephone>+98 34 1322 5077</telephone>
        <email>mryani@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansor Arab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The second room on the right, second floor, Nursing and Midwifery, Haftbagh, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۶۱۸۷۴۷۶۵۳</zip>
        <telephone>+98 34 1226 0588</telephone>
        <email>marab112004@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Exclusion criteria: Venipuncture to diagnosis doctor; Ability to respond to visual analog scale; Parental consent to participate in research; Children's oral consent to participate in research; Accompanied by a parent in the study and first venipuncture experience when admitted. Inclusion criteria: use of drugs that alter children's consciousness; Sensitivity to anesthetic spray and cold; Specific diseases (thyroid disorders, epilepsy, peripheral vascular disease or disease that causes loss of consciousness in children); Reject to participate; Severe pain; Urgent need for venipuncture; Get another non-pharmacological methods of pain control during the procedure and deficiency of physical and mental health to the extent that it is prevented from doing research (word - mentally - visual – physica).</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Researcher prior to venipuncture to children and their parents participated in intervention group, branoll and supplies for venipuncture showed and describeto the about how to open up and fix IV. In addition to this equipment, evaporative spray in test group was added, and the children and their families was explained that the purpose of using the spray is only to reduce pain. Evaporative spray used in this study is freeze spray product in Italy, the exclusive representative of the company of modern medicine is expensive equipment. Vapocoolant sprays are rapid-acting alternatives to topical anesthetics. The material used in spray is isopropyl alcohol. They provide transient anesthesia via evaporation-induced skin cooling, which reduces pain. Evaporative spray after being sprayed,  destroys the skin hot  and with disabling pain receptors can cause temporary numbness. The vapocoolant spray that we studied is a nonflammable, nontoxic and ozone-friendly spray. It is easy to apply, is less expensive than alternatives, works instantaneously, does not require a needle or needle-like device and is relatively innocuous.  Side effects include rare allergic reactions and minor temporary skin changes. Unfortunately, skin changes may become permanent if the topical spray exceeds 10 seconds because severe local hypothermia may cause the death of local cells Area of  the venipuncture was bent elbow. In the test group before venipuncture, evaporative spray was used,It was to be sprayed at room temperature by the researcher from a distance of25-30 cm for 5-10 seconds until the white and pale skin would have and Because of the short-acting, 40-30 seconds after the vessel began taking by special nurse.In addition, the intervention group before venipuncture first spray was and after the area was Sterilization. To reduce the effect of confounding factors, the sterilization procedures and venipuncture was performed completely identical in intervention group. Practice of opening a vein in all  of the sample, in intervention group were performed by nurses with pediatric experience. Behavioral pain scale in children during procedures in intervention group were observed and recorded by the nurse researcher. After injection pain in children by means of numerical pain was assessed by the children themselves..</i_keyword>
      <i_keyword>Control group: In the control group used of placebo  spray that Similar to the form used in the intervention group but with normal Saylyn . How to use a placebo spray Practice of opening vein and the instruments and area of  the venipuncture in Control group were similar to intervention group. In the Control group before venipuncture, placebo  spray was used,It was to be sprayed at room temperature by the researcher from a distance of25-30 cm for 5-10 seconds, 40-30 seconds after the vessel began taking by special nurse.In addition, the Control group before venipuncture first spray was and after the area was Sterilization. Practice of opening a vein in all  of the sample, in Control group were performed by nurses with pediatric experience. Behavioral pain scale in children during procedures in Control group were observed and recorded by the nurse researcher. After injection pain in children by means of numerical pain was assessed by the children themselves</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: During and immediately after the intervention. Method of measurement: \ numeric scale &amp; behavioral scale to measure pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Skin effects. Timepoint: During and after the intervention. Method of measurement: Observation.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>Not in place</sec_id>
        <issuing_authority>Not in place</issuing_authority>
      </secondary_id>
      <secondary_id>
        <sec_id>در جایی ثبت نشده است</sec_id>
        <issuing_authority>در جایی ثبت نشده است</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor for research, Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>The ethics committee of Kerman university of medical sciences</contact_name>
        <contact_address>The ethics committee, second floor, Kerman university of medical sciences,Republic Blvd Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
