<?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>IRCT20241114063711N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-18</date_registration>
      <primary_sponsor>University of Kerbala</primary_sponsor>
      <public_title>Effect of Distraction Technique Using the Virtual  Reality on Cardiopulmonary Parameters, Level of Pain  and Anxiety in Patients after Percutaneous Coronary  Intervention</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Distraction Technique Using the Virtual  Reality on Cardiopulmonary Parameters, Level of Pain  and Anxiety in Patients after Percutaneous Coronary  Intervention</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-11-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80184</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to maintain a transparent and scientific-based randomization process, simple randomization will be used in assigning participants (individuals:  percutaneous coronary intervention patients), to intervention (virtual reality program) and control groups, patients who received percutaneous coronary intervention at the Kerbala Center for Cardiac Diseases and Surgery and AL-Imam AL-Hassan Al-Mujtaba Teaching Hospital were chosen at random (simple random sampling). A study group of 72 patients had to be present, and a control group of 72 patients was chosen. (The trial group received the intervention regimen, which consisted of a 15-minute virtual reality program following percutaneous coronary intervention).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cardiac Diseases.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After percutaneous coronary intervention, the  virtual reality headset as part of this protocol. After putting the patient in a semi-fowler and sitting position, the virtual reality goggles are worn for fifteen minutes. After that, a variety of soothing 3D videos are shown, including a natural video with soothing music. The patient has the option to stop or switch the chosen video at any moment. Intervention 2: Control group: For the control group, no interventions will be don.</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:
Effect of Distraction Technique Using the Virtual 
Reality on Cardiopulmonary Parameters, Level of Pain 
and Anxiety in Patients after Percutaneous Coronary 
Intervention

When:
God Willing, once the article is published, the data will be available after 6 months of publication. If the article will be published in a subscribed journal, the data will be available after one year because of the policy of the subscribed journals.

To whom:
With academic nurses and any researcher who is interested in the data.

Conditions:
The data could be used after getting the permission via email. Also, users need to acknowledge the owner.

Where to obtain:
Users can ask for the data and the permission via email is the corresponding author. He will be in contact with whom ask for the data. His email ali.ibrahim@s.uokerbala.edu.iq Also, works at University of Kerbala/ College of Nursing. The address is Bab-Tuerag, Kerbala, Iraq.

How to obtain:
Users can ask for the data and the permission via email. Ali is the corresponding author. He will be in contact with whom ask for the data. His email is ali.ibrahim@s.uokerbala.edu.iq

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Hassan Ibrahim Shutnan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bab-Tuerag</address>
        <city>Kerbala City</city>
        <country1>Iraq</country1>
        <zip>56001</zip>
        <telephone>+964 782 342 9547</telephone>
        <email>ah5917079@gmail.com</email>
        <affiliation>University of Kerbala</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Hassan Ibrahim Shutnan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bab-Tuerag</address>
        <city>Kerbala City</city>
        <country1>Iraq</country1>
        <zip>56001</zip>
        <telephone>+964 782 342 9547</telephone>
        <email>ali.ibrahim@s.uokerbala.edu.iq</email>
        <affiliation>University of Kerbala</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A patient who was admitted to the hospital following percutaneous coronary intervention.
Males and females who are at least eighteen years old.
Patients who are open to taking part in the research.
Patients with verbal communication skills and intellectual capacity.
Individuals without hearing or vision impairments.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Young children under the age of eighteen.
Individuals involved in diagnostic catheterization.
Individuals with impaired hearing and vision abilities.
Patients who experienced hematoma, hemorrhage, arrhythmia, asystole, or other postoperative complications or postponed.
Pilot study participants.
Patients decline to take part in the trial.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery with angina pectoris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After percutaneous coronary intervention, the  virtual reality headset as part of this protocol. After putting the patient in a semi-fowler and sitting position, the virtual reality goggles are worn for fifteen minutes. After that, a variety of soothing 3D videos are shown, including a natural video with soothing music. The patient has the option to stop or switch the chosen video at any moment.</i_keyword>
      <i_keyword>Control group: For the control group, no interventions will be don.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome variable is the level of pain and anxiety that can be changed based on virtual reality. Timepoint: fifteen minutes after intervention directly. Method of measurement: The Visual analogue scale (VAS) for pain aoutcom.</prim_outcome>
      <prim_outcome>The primary outcome variable is the level of anxiety that can be changed based on virtual reality. Timepoint: fifteen minutes after intervention directly. Method of measurement: The Visual analogue scale (VAS-A) for anxiety aoutcom.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>University of Kerbala</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The author of the trial is the funding source</source_name>
      <source_name>The author of the trial is the funding source</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-27</approval_date>
        <contact_name>Ethics committee in College of Nursing at University of Kerbala</contact_name>
        <contact_address>Bab-AlTuareg Kerbala City Kerbala Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
