<?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>IRCT20190815044536N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-06</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of virtual reality on catheter insertion anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Effect of virtual reality distraction on anxiety from intravenous catheter placement and adherence to treatment in children 6 to 15 years with cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41638</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Research units from the research community that meet the research criteria will first be selected as accessible and purpose-based, and then randomly assigned to a 4-block permutation method in two virtual reality and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety in children with cancer during the process of obtaining an angiocut.</hc_freetext>
      <i_freetext>Intervention 1: Evaluation of venous placement and venous placement will be undertaken as the glasses are put on and the child calming clip begins to air. Anxiety levels will be measured and recorded by standard instruments before and immediately after the venous process is completed.To assess treatment adherence at the next follow-up (one month later) in the intervention and control group, the self-adherence questionnaire of treatment adherence will be completed by the researcher by interviewing parents or children. Intervention 2: Anxiety tool will be completed before and after the vein is completed. To assess treatment adherence at the next follow-up (one month later) in the intervention and control group, the self-administered adherence questionnaire will be completed by the researcher by interviewing parents or children.</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:
All potential data can be shared after unidentifiable people.

When:
Start of access period from 1399

To whom:
Researchers working in academic and scientific institutions

Conditions:
To guide and design the type of study and way of working for researchers working in academic and scientific institutions

Where to obtain:
1.Email address:MosaddeghMR1@mums.ac.ir
2.2. Contact with phone number:09151179193

How to obtain:
Request an Email Address and Submit a Request for Voice and No Replies Contact Cell Phone: 09151179193

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Mossadegh Hesari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Sheikh Pediatric Hospital، Martyr Gharani 6، Shahid Gharani Boulevard</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188766956</zip>
        <telephone>+98 51 3726 9021</telephone>
        <email>MosaddeghMR1@mums.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Mossadegh Hesari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Sheikh Pediatric Hospital، Shahid Gharani 6، Shahid Gharani Boulevard</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188766956</zip>
        <telephone>+98 51 3604 6516</telephone>
        <email>MosaddeghMR1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent to participate in the research ..
Children aged 6 to 15 years
Children with cancer with a history of venous puncture in the maintenance phase
The child should be fully alert
The patient is inclined to use virtual glasses
Use of distal organs vessels</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>"Use of proximal child vessels for angiectomy"
"Children over 15 years or under 6 years"
"Children with cancer before entering the maintenance phase of treatment"</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Evaluation of venous placement and venous placement will be undertaken as the glasses are put on and the child calming clip begins to air. Anxiety levels will be measured and recorded by standard instruments before and immediately after the venous process is completed.To assess treatment adherence at the next follow-up (one month later) in the intervention and control group, the self-adherence questionnaire of treatment adherence will be completed by the researcher by interviewing parents or children.</i_keyword>
      <i_keyword>Anxiety tool will be completed before and after the vein is completed. To assess treatment adherence at the next follow-up (one month later) in the intervention and control group, the self-administered adherence questionnaire will be completed by the researcher by interviewing parents or children.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in the observation tool(OSBD-R ). Timepoint: Measuring and observing anxious behavior 5 minutes before and immediately after the intervention. Method of measurement: Anxiety Assessment Tool (OSBD-R)                                       A researcher-made treatment adherence assessment tool.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart beat. Timepoint: Before the intervention, during the intervention, immediately after the intervention. Method of measurement: Pulse Oximeter Device.</sec_outcome>
      <sec_outcome>Arterial Blood Oxygen Level. Timepoint: Before the intervention, during the intervention, immediately after the intervention. Method of measurement: Pulse Oximeter Device.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-05</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Shahid Gharani Boulevard, Shahid Gharani 2, Dr. Sheikh Mashhad Pediatric Hospital Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
