<?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>IRCT20220611055134N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-12</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of tele-nursing self-care training on anxiety and quality of life in Avestin-treated patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of tele-nursing self-care training on anxiety and quality of life in Avestin-treated Diabetic retinopathy patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64083</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is block type.To ensure an equal number of people in the study, a randomized permutation block method will be used in both groups.For this purpose, we will use the www.sealedenvelope.com website. in this way, 19 blocks of 4 members are randomly created through the site.The researcher assigns the sample to the groups. By listing the patients selected based on the inclusion criteria by the doctor, the researcher first groups the samples and then meets with the patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetic retinopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first stage of the researcher's face-to-face meeting with the patient, the researcher completes the demographic information questionnaire, quality of life questionnaires and overt and covert Spielberger questionnaire as a pre-test with the patient's help.From the time of the first appointment to the day of the Austin drug injection (one day later), the researcher sends short audio and video files of 3-4 minutes through the WhatsApp application, which includes pre-injection care and how to inject, as a personal message to The patient sends.In the morning of the injection, the anxiety questionnaire is completed for the second time. The patient is then injected by the doctor and as soon as he/she is discharged from the Austin drug injection unit, a file containing post-injection care, symptoms and complications of the injection is sent to the patient.From the day after the day of the injection until the night of the second injection for four weeks (intervals between each injection is one month) files containing how to measure and control blood sugar, importance and how to fill the blood sugar chart, importance and how to control diet, activity and Exercise is sent twice a week in a personal message (pv) and each time after receiving feedback from the patient.The night before the second injection (one month later), the files related to the injection (pre-injection care and injection method) are sent to the patient again. On the morning of the second injection (before the injection), the patient completes the anxiety questionnaire for the third time. After the injection, the patient is discharged from the Austin drug injection unit and the audio and video files continue to be sent for another month. After two months before the doctor's visit, the quality of life and anxiety questionnaire will be checked.Each time the files are sent, if a question arises for the patient, the question is first raised with the professors in the research and after receiving an answer from them, the answer is sent to the patient. Intervention 2: Control group: During the intervention, the control group will receive the routine care of the hospital, such as educational pamphlets available in the hospital, and after completing the study, they will receive all audio and video files and pamphlets prepared from the intervention product.</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:
The plan in this study is to publish the final report in the form of an article and a senior thesis.

When:
Probably, the results of this study will be published and made available to the public in the next two years.

To whom:
All researchers working in different institutions

Conditions:
All researchers who intend to conduct meta-analysis and systematic review studies in the future can use the results of this study. Also, they can request more data in this field from researchers.

Where to obtain:
Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery
Postal code: 9137913199
Fax: 051 38597313
Phone: 051-38591511-3
Email: nms.pr@mums.ac.ir /  aghebatin@mums.ac.ir  / keshavarziane981@mums.ac.ir
Respondents: Nahid Aghebati / Elaheh Keshavarzian / Mashhad College of Nursing and Midwifery Library

How to obtain:
Request from the corresponding author using email

Comments:
thanks</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Aghebati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Aghebatin@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Aghebati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>aghebatin@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of diabetic retinopathy by a doctor
Diagnosis of a candidate for Avastin by a doctor
Having a smart phone
Having enough hearing
Having a minimum literacy
Lack of other eye diseases
No history of psychological illness
Satisfaction for participation</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having previous experience of injecting Avastin</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy</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: In the first stage of the researcher's face-to-face meeting with the patient, the researcher completes the demographic information questionnaire, quality of life questionnaires and overt and covert Spielberger questionnaire as a pre-test with the patient's help.From the time of the first appointment to the day of the Austin drug injection (one day later), the researcher sends short audio and video files of 3-4 minutes through the WhatsApp application, which includes pre-injection care and how to inject, as a personal message to The patient sends.In the morning of the injection, the anxiety questionnaire is completed for the second time. The patient is then injected by the doctor and as soon as he/she is discharged from the Austin drug injection unit, a file containing post-injection care, symptoms and complications of the injection is sent to the patient.From the day after the day of the injection until the night of the second injection for four weeks (intervals between each injection is one month) files containing how to measure and control blood sugar, importance and how to fill the blood sugar chart, importance and how to control diet, activity and Exercise is sent twice a week in a personal message (pv) and each time after receiving feedback from the patient.The night before the second injection (one month later), the files related to the injection (pre-injection care and injection method) are sent to the patient again. On the morning of the second injection (before the injection), the patient completes the anxiety questionnaire for the third time. After the injection, the patient is discharged from the Austin drug injection unit and the audio and video files continue to be sent for another month. After two months before the doctor's visit, the quality of life and anxiety questionnaire will be checked.Each time the files are sent, if a question arises for the patient, the question is first raised with the professors in the research and after receiving an answer from them, the answer is sent to the patient.</i_keyword>
      <i_keyword>Control group: During the intervention, the control group will receive the routine care of the hospital, such as educational pamphlets available in the hospital, and after completing the study, they will receive all audio and video files and pamphlets prepared from the intervention product.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in Spielberger overt and covert anxiety questionnaire. Timepoint: Anxiety will be measured before the intervention ,before the first injection , before the second injection and after the intervention. Method of measurement: Spielberger overt and covert anxiety questionnaire.</prim_outcome>
      <prim_outcome>Quality of life measuring with SF36 quality of life questionnaire. Timepoint: before the intervention and two months after the quality of life of patients will be measured. Method of measurement: Sf 36 questionnaire will be used to measure the quality of life of patients.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-07</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ebne sina avenue-school of nursing and midwiferry Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
