<?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>IRCT20230330057785N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-18</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational program on patients' anxiety</public_title>
      <acronym></acronym>
      <scientific_title>the effect of educational program based on Newman's systemic model on the anxiety of eye surgery candidates</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69493</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants will be randomly divided into two intervention groups or control groups using the block method. For this purpose, with the help of the site www.sealedenvelope.com and by specifying the number of participants, the number of groups, the size of the blocks, the list and the order of the participants will be determined. Then the group list (intervention, control) of the participants will be written in the sealed envelope in order, and after determining the criteria for entering the patients, it will be opened to determine their group.
It is necessary to explain that blocking will be done by someone other than the researcher.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Candidate patients for eye surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Intervention group: The day before the surgery, the intervention will be performed by the researcher according to Betty Newman's systemic nursing model. The examination tool provided by Betty Newman in this model is related to the totality of the individual and includes the following 3 principles: 1- Full knowledge of the factors that affect the understanding of the patient. 2- Approving and valuing a stressor by the patient and caregiver. 3- Factors that affect the caregiver's mind in examining the patient's condition,  In this regard, the researcher identifies the factors affecting their anxiety. In the evaluation stage of Newman's systemic model, first, potential/actual tensions, appropriate goals and strategies for actions will be determined, and then natural and flexible defense lines will be strengthened, in which the penetration of stressful factors into the line will be strengthened. Natural defenses will be prevented and the intensity of the reaction will be reduced. The educational content at the level of first prevention includes: explaining the eye anatomy, the role of proper nutrition in relieving stress and anxiety and creating confidence in the hospital and operating room environment, post-operative care and instructions (how to bathe, the position of the patient while sleeping, and taking medications) Was.In the second level of prevention, the compromised natural and flexible defense lines will be restored. The intervention aimed at strengthening the internal defense lines will be carried out in order to reduce the reaction to stressful factors. Educational content at the level of secondary prevention includes: intervention based on the needs and stress factors diagnosed by the patient and the nurse based on Newman's stress factors:• Intrapersonal (awareness of rehabilitation stage, care at home, awareness of surgery, time to return to the ward, awareness of nutrition therapy)• Interpersonal (explaining hospital treatment methods, psychological support, communicating with patients and providing information about drugs)• It will be extroverted (providing information about insurance and paying expenses, talking to the health department and referring patients to charities, creating a calm environment and reducing noise).In the third level of prevention, the use of public system resources, including internal and external environments, will be maximized. The educational content in the third level of prevention will include: the implementation of Benson's sedation method to improve sedation responses. Intervention 2: The control group will receive routine ward care.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Aghajanloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr Sobouti (Gavazang) Blvd, Central Campus of Zanjan University of Medical Science,School of Nursing and Midwifery</address>
        <city>Zajnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956113</zip>
        <telephone>+98 24 3314 8123</telephone>
        <email>aliaghajanloo2001@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Aghajanloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr Sobouti (Gavazang) Blvd, Central Campus of Zanjan University of Medical Science,School of Nursing and Midwifery</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956113</zip>
        <telephone>+98 21 3314 8123</telephone>
        <email>aliaghajanloo2001@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Not having psychological diseases
Not taking anti-anxiety drugs
Not being addicted to opioids or narcotic painkillers
Having consent to study
Having surgery in the eye area</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of cooperation or patient satisfaction at any stage of the study
Aggravation of the patient's conditions during the study and the need for advanced interventions</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Intervention group: The day before the surgery, the intervention will be performed by the researcher according to Betty Newman's systemic nursing model. The examination tool provided by Betty Newman in this model is related to the totality of the individual and includes the following 3 principles: 1- Full knowledge of the factors that affect the understanding of the patient. 2- Approving and valuing a stressor by the patient and caregiver. 3- Factors that affect the caregiver's mind in examining the patient's condition,  In this regard, the researcher identifies the factors affecting their anxiety. In the evaluation stage of Newman's systemic model, first, potential/actual tensions, appropriate goals and strategies for actions will be determined, and then natural and flexible defense lines will be strengthened, in which the penetration of stressful factors into the line will be strengthened. Natural defenses will be prevented and the intensity of the reaction will be reduced. The educational content at the level of first prevention includes: explaining the eye anatomy, the role of proper nutrition in relieving stress and anxiety and creating confidence in the hospital and operating room environment, post-operative care and instructions (how to bathe, the position of the patient while sleeping, and taking medications) Was.In the second level of prevention, the compromised natural and flexible defense lines will be restored. The intervention aimed at strengthening the internal defense lines will be carried out in order to reduce the reaction to stressful factors. Educational content at the level of secondary prevention includes: intervention based on the needs and stress factors diagnosed by the patient and the nurse based on Newman's stress factors:• Intrapersonal (awareness of rehabilitation stage, care at home, awareness of surgery, time to return to the ward, awareness of nutrition therapy)• Interpersonal (explaining hospital treatment methods, psychological support, communicating with patients and providing information about drugs)• It will be extroverted (providing information about insurance and paying expenses, talking to the health department and referring patients to charities, creating a calm environment and reducing noise).In the third level of prevention, the use of public system resources, including internal and external environments, will be maximized. The educational content in the third level of prevention will include: the implementation of Benson's sedation method to improve sedation responses.</i_keyword>
      <i_keyword>The control group will receive routine ward care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and after the intervention. Method of measurement: Spielberger 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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-12</approval_date>
        <contact_name>Ethics committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medical Sciences , Dr.Sobouti Blvd. Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
