<?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>IRCT20210117050059N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-06</date_registration>
      <primary_sponsor>Trabiat Modares University</primary_sponsor>
      <public_title>educational intervention program using mobile application regarding caring behavior on postoperative in patients undergoing lumbar disc herniation surgery</public_title>
      <acronym>LDH</acronym>
      <scientific_title>Designing , implementation and evaluation of educational intervention program using mobile application regarding caring behavior on postoperative in patients undergoing lumbar disc herniation surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54628</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Educational intervention in the field of care behaviors after lumbar disc herniation is provided to patients through smart mobile application software, Randomization description: In this study, the block randomization method is used. Thus, the researcher identified the people eligible to participate in the study by visiting the hospital. Then, the identified individuals who volunteered to participate in the study were randomly assigned to the experimental and control groups using a quadratic blocking method. The letter A was considered for the intervention group and the letter B for the control group. Then all the permutation compounds of the letters AA and BB, which are 6 different compounds, were written (AABB for combination 1, ABBA for combination 2, ...) and from combinations 1 to 6, one combination was randomly selected. For example, if combination 1 was selected, it meant that the first and second people were in the experimental group and the next two people were in the control group, and this process continued continuously until the sample size was reached.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lumbar Disc Herniation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention includes three phases: pre-test, content training, and post-test. Pre-test in both intervention and control groups is sent to their mobile phone as an online questionnaire. The application is designed to be installed on the smartphones of the intervention group, ie patients undergoing disc herniation surgery, and how to use it is explained to people. Educational content about caring behaviors after lumbar disc herniation surgery in the intervention group will be activated immediately after completing the pre-test form. Patients have access to educational content for 4 weeks at any time and place. At the end of 4 weeks, access to the educational content is automatically disabled. And the link to receive the post-test is sent by the researcher immediately, one month later, and three months after the educational intervention to both intervention and control groups. The questions are the same in both the pre-test and post-test stages. Intervention 2: Control group: The intervention includes three phases: pre-test, content training and post-test. Pre-tests in both intervention and control groups are sent as an online questionnaire to their mobile phones. This group does not receive any training on caring behavior with the help of smart mobile application software. Post-test questionnaire is sent to the control group mobile phone immediately, one and three months after the educational intervention by the researcher.</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 on the main consequences can be shared.

When:
Access period starts 6 months after the results are published

To whom:
The data will be available only to researchers working in academic and scientific institutions.

Conditions:
Repeated  measurement analysis to evaluate the duration of training 6 months after the last intervention

Where to obtain:
By sending an email to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir

How to obtain:
One week after sending the email by the applicant to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir will be answered.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115111</zip>
        <telephone>+98 21 8288 4546</telephone>
        <email>f.zarei@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115111</zip>
        <telephone>+98 21 8288 4546</telephone>
        <email>f.zarei@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients are candidates for lumbar disc herniation surgery
Having a smartphone and knowing how to use it
Has not received training before the intervention
literate</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with mental disorders.
Patients with learning disabilities.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M51.26</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other intervertebral disc displacement, lumbar region</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: The intervention includes three phases: pre-test, content training, and post-test. Pre-test in both intervention and control groups is sent to their mobile phone as an online questionnaire. The application is designed to be installed on the smartphones of the intervention group, ie patients undergoing disc herniation surgery, and how to use it is explained to people. Educational content about caring behaviors after lumbar disc herniation surgery in the intervention group will be activated immediately after completing the pre-test form. Patients have access to educational content for 4 weeks at any time and place. At the end of 4 weeks, access to the educational content is automatically disabled. And the link to receive the post-test is sent by the researcher immediately, one month later, and three months after the educational intervention to both intervention and control groups. The questions are the same in both the pre-test and post-test stages.</i_keyword>
      <i_keyword>Control group: The intervention includes three phases: pre-test, content training and post-test. Pre-tests in both intervention and control groups are sent as an online questionnaire to their mobile phones. This group does not receive any training on caring behavior with the help of smart mobile application software. Post-test questionnaire is sent to the control group mobile phone immediately, one and three months after the educational intervention by the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge about caring behaviors after lumbar disc herniation surgery. Timepoint: Immediately after the educational intervention, one month after the educational intervention. Method of measurement: Through a researcher-made questionnaire of LUmbar CAring Tool (LUCAT).</prim_outcome>
      <prim_outcome>Improving attitudes about caring behaviors after lumbar disc herniation surgery. Timepoint: Immediately after the educational intervention, one month after the educational intervention. Method of measurement: Through a researcher-made questionnaire made by LUCAT.</prim_outcome>
      <prim_outcome>Performance on care behaviors after lumbar disc herniation surgery. Timepoint: Immediately after the educational intervention, one month after the educational intervention. Method of measurement: Through a researcher-made questionnaire made by LUCAT.</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>Trabiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-20</approval_date>
        <contact_name>Trabiat Modares University</contact_name>
        <contact_address>Jalal Al-Ahmad St., Nasr Bridge, Tarbiat Modares University, School of Medicine Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
