<?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>IRCT20230802059007N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-03</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the presence companion nurse program on anxiety and physiological indicators of angiography candidate patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the impact of the presence companion nurse program on the anxiety and physiological indicators of angiography candidate patients in the waiting room</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72236</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Other design features: This study has two groups (intervention and control). The cath lab routine program is carried out in the control group, but the presence companion nurse program is carried out in the intervention group. Only one type of intervention (the presence companion nurse program) is performed on patients in the intervention group, Randomization description: In this research, According to previous studies, The samples were first selected by the available sampling method and then randomly allocated using Random Allocation software in two intervention (A) and control (B) groups.
Therefore, for this purpose, first, the researcher introduced himself to the patients who met the criteria for entering the study, and explanations were given regarding the study and its objectives. Then, following all the ethical and scientific criteria, a list of candidate patients for angiography was prepared and numbered. The target sample was selected by random allocation. Explaining that the allocation of research units to two groups was done using random allocation software is necessary.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cardiovascular disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the presence companion nurse program -On the day of angiography, upon entering the waiting room, the patient's anxiety level and physiological indicators were determined, then the nurse's presence plan was implemented for the patient, after the intervention, when entering the angiography room, the patient's anxiety level and physiological indicators were rechecked. The presence companion nurse program was carried out for each patient individually in the intervention group. In this study, the companion nurse is the researcher. Also, the cath lab routine program was implemented in the control group. Just before entering the waiting room and also the angiography room, the Hamilton anxiety questionnaire was taken. Intervention: Introduction of cath lab space - introduction of personnel and a friendly and trusting atmosphere for the patient - explaining how to perform the angiography procedure in simple language - psychological support (being responsive to the patient's questions) - assuring the patient that we will wait for her until the end of the procedure. Intervention 2: Control group: cath lab routine program - also in the control group, the cath lab routine program was implemented. Before entering the waiting room and also the angiography room, the Hamilton anxiety questionnaire was taken. The routine program of the department is as follows: after patients are delivered by the ward nurse, the patient's information is checked, and the patients are checked for lack of equipment and dentures. Then, the patients wait for the angiography room to be empty.</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:
Part of the data, such as information related to anxiety, can be shared.

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic institutions of medical sciences

Conditions:
Research on angiography candidate patients

Where to obtain:
sajjad salehian - st.sajad73@gmail.com

How to obtain:
After receiving the email, it will receive the data for one month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sajjad Salehian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 88, Shahid Rajaei Blvd</address>
        <city>Tabas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9791864746</zip>
        <telephone>+98 56 3282 4317</telephone>
        <email>sajjadsalehian@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Simin Sharafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran.</address>
        <city>birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۷۱۷۸۵۳۰۷۶</zip>
        <telephone>+98 56 3239 5000</telephone>
        <email>Siminsharafi68@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Angiography is not an emergency patient
Hospitalization in the relevant cardiac departments
Ability to communicate verbally
Being a candidate for an angiography procedure for the first time
Not having vision and hearing problems
No drug addiction
Avoid using sedatives
No epilepsy or mental illness
No high blood pressure
Not receiving anti-anxiety drugs before the procedure
Willingness to participate in the study and complete the written informed consent form
The patient is not part of the treatment team</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Life-threatening problems including rhythm disorders (arrhythmias)
Waiting time of less than 20 minutes
Angiography for several times</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I51.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cardiovascular disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the presence companion nurse program -On the day of angiography, upon entering the waiting room, the patient's anxiety level and physiological indicators were determined, then the nurse's presence plan was implemented for the patient, after the intervention, when entering the angiography room, the patient's anxiety level and physiological indicators were rechecked. The presence companion nurse program was carried out for each patient individually in the intervention group. In this study, the companion nurse is the researcher. Also, the cath lab routine program was implemented in the control group. Just before entering the waiting room and also the angiography room, the Hamilton anxiety questionnaire was taken. Intervention: Introduction of cath lab space - introduction of personnel and a friendly and trusting atmosphere for the patient - explaining how to perform the angiography procedure in simple language - psychological support (being responsive to the patient's questions) - assuring the patient that we will wait for her until the end of the procedure</i_keyword>
      <i_keyword>Control group: cath lab routine program - also in the control group, the cath lab routine program was implemented. Before entering the waiting room and also the angiography room, the Hamilton anxiety questionnaire was taken. The routine program of the department is as follows: after patients are delivered by the ward nurse, the patient's information is checked, and the patients are checked for lack of equipment and dentures. Then, the patients wait for the angiography room to be empty.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Measuring anxiety at the beginning of the study (before the start of the intervention) and after half an hour after the intervention. Method of measurement: Hamilton anxiety questionnaire.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-10</approval_date>
        <contact_name>Ethics committee of birjand University of Medical Sciences</contact_name>
        <contact_address>Birjand University of Medical Sciences , Ghafari Street, Birjand, South Khorasan, Iran. birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
