<?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>IRCT20100823004617N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-18</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>"The Effect of Two Methods of Distraction and Acupressure on Pain and Anxiety"</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Two Methods of Distraction and Acupressure on Pain and Anxiety of Peripheral Intravenous Cannulation in School-age Pediatric Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38933</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: This is an experimental study that is a cross-over clinical trial, in which all the specimens are randomly assigned three times under the intravenous insertion procedure with randomized, routine, deviation, and acupressure. Among these three methods, the washout period is considered to be 24 to 72 hours. To conceal allocation, the child is asked to choose one of the opaque envelopes. Each envelope contains a triple block (watch a cartoon movie = A and a Hugo point massage = B) and a control (C) that shows the order of the intervention on the child. These envelopes are already being prepared by a research collaborator using the Randlist software, Blinding description: The data analyzer does not know how to assign the samples to the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: in the intervention method a minute before the onset of intravenous line insertion , the child pain score was determined using the vas scale and the child anxiety score using the fas scale . the child will then be directed to an intravenous line . the sponge bob sponge is placed on the throne of the patient from the time the child is placed on the couch through the virtual space cameras that is placed on the retina of the patient and has the ability to transmit sound and the image . one minute after finishing the insertion , the child 's pain score and anxiety score will be recorded . Intervention 2: Intervention group: in method of  B , acupressure was determined before informing the child , child pain score using vas scale and child anxiety score using the fas scale . then the child is directed to the insertion of the intravenous line and the child is placed on the vein and then hugo 's point is determined . to determine the point of hugo in the intervention group , the finger of the child 's thumb is referred to the finger and in this case the peak muscle is produced . about five minutes before the procedure and by placing the child on the bed , the point will be massage in a rotating and relaxed position while the child is placed on the sofa by the researcher , so that the maximum pressure time per time is 1 minute and then the massage is discontinued for one minute . the procedure will continue until the procedure is completed . it should be noted that the insertion of the intravenous line in the hands of hugo is performed . one minute after finishing the insertion , the child 's pain score and anxiety score will be recorded . Intervention 3: Control group: In the routine procedure, intravenous infusion will be performed as per routine procedure and the child will receive no additional intervention before or during intravenous infusion. Before announcing the baby's intravenous replacement, the child's pain and anxiety score will be determined using one of two scales. The child will then be directed to the IV line room and placed on the IV line bed. Then the child's vein embedding is performed by the researcher. The child's pain and anxiety scores will be recorded again one minute after the intravenous embolization is completed.</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:
---

When:
---

To whom:
---

Conditions:
---

Where to obtain:
---

How to obtain:
---

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mohammad saeidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati South St, Faculty of Nursing and Midwifery,Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 44 3223 7816</telephone>
        <email>mohamadsaeidi670624@gmail.cim</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz jabraeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati South St, Faculty of Nursing and Midwifery,Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5138947977</zip>
        <telephone>+98 41 3479 6770</telephone>
        <email>Jabraelim@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children aged 12-6 admitted in the oncology department
Full conscious to place, time and person
The ability to communicate verbally
Having a previous experience of peripheral intravenous cannulation
Acquiring informed consent of the child and parents
The health of the eyes and the hearing</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of pain relief medications 8 hours prior to  peripheral intravenous cannulation
More than one catheter entry into the skin
The location of the Hugo Point has a previous injury  and pain.
Perform a painful procedure on the baby within 8 hours of the baby's stroke</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: in the intervention method a minute before the onset of intravenous line insertion , the child pain score was determined using the vas scale and the child anxiety score using the fas scale . the child will then be directed to an intravenous line . the sponge bob sponge is placed on the throne of the patient from the time the child is placed on the couch through the virtual space cameras that is placed on the retina of the patient and has the ability to transmit sound and the image . one minute after finishing the insertion , the child 's pain score and anxiety score will be recorded .</i_keyword>
      <i_keyword>Intervention group: in method of  B , acupressure was determined before informing the child , child pain score using vas scale and child anxiety score using the fas scale . then the child is directed to the insertion of the intravenous line and the child is placed on the vein and then hugo 's point is determined . to determine the point of hugo in the intervention group , the finger of the child 's thumb is referred to the finger and in this case the peak muscle is produced . about five minutes before the procedure and by placing the child on the bed , the point will be massage in a rotating and relaxed position while the child is placed on the sofa by the researcher , so that the maximum pressure time per time is 1 minute and then the massage is discontinued for one minute . the procedure will continue until the procedure is completed . it should be noted that the insertion of the intravenous line in the hands of hugo is performed . one minute after finishing the insertion , the child 's pain score and anxiety score will be recorded .</i_keyword>
      <i_keyword>Control group: In the routine procedure, intravenous infusion will be performed as per routine procedure and the child will receive no additional intervention before or during intravenous infusion. Before announcing the baby's intravenous replacement, the child's pain and anxiety score will be determined using one of two scales. The child will then be directed to the IV line room and placed on the IV line bed. Then the child's vein embedding is performed by the researcher. The child's pain and anxiety scores will be recorded again one minute after the intravenous embolization is completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain caused by peripheral intravenous cannulation. Timepoint: Before the intervention and after the intervention. Method of measurement: VAS tool.</prim_outcome>
      <prim_outcome>Anxiety caused by peripheral intravenous cannulation. Timepoint: Before the intervention and after the intervention. Method of measurement: FAS tool.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-06</approval_date>
        <contact_name>Tabriz University of Medical Sciences Ethics committee</contact_name>
        <contact_address>Tabriz University of Medical Sciences, Golgasht Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
