<?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>IRCT20180913041022N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-10</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of needs-based education on postoperative complications of patients with knee arthroplasty</public_title>
      <acronym></acronym>
      <scientific_title>Effect of needs-based education on postoperative complications of patients with knee arthroplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34093</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: A researcher-made questionnaire was used in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Complications after knee replacement.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group completed the demographic and needs assessment questionnaires before surgery. Sample training was done so that prior to the beginning of the training, a questionnaire on the needs assessment of the educational priorities was determined based on the educational needs of the patient, then each person was trained according to his needs. Individual and face-to-face training was provided for 3 days from day before surgery or the same day until the day of discharge per day for 15-20 minutes at patient's tolerance and capacity, and a manual was provided to patients in the intervention group . Patient education was also conducted by telephoning and meeting the patient's needs by answering his questions and ambiguities by availability of the researcher (telephone number was provided to the patients) at the time of discharge and telephone answering. And the researcher himself also contacted the patient every week and ensure patient follow up and answer the patient's questions. Intervention 2: Control group: Patients in the preoperative control group completed the demographic information and needle assessment questionnaire. Patients in the control group received only regular training.</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:
Information about the questionnaire, statistical information, and outcomes are available

When:
Starting the access period from 1399

To whom:
For researchers working in academic and scientific institutions

Conditions:
For researchers working in academic and scientific institutions, students and research centers

Where to obtain:
Responsive email address of Saeedeh Shakeri
saide.sha.3@gmail.com

How to obtain:
Your application will be processed within one month after your request has been made

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeedeh Shakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Okhubat Alley 10, Bu-Ali Sina Street, Qods Town</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0</zip>
        <telephone>+98 86 3366 3112</telephone>
        <email>saide.sha.3@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Daryadokht Masror</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing School, Yasemi Rashid Ave., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 4365 1709</telephone>
        <email>daryadokht_masror@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient with knee joint disease (recorded in the file)
Have reading and writing skills
Age over 18 years
Not having previous experience in training programs
Not having previous joint replacement history
Replacement candidate for one knee
Lack of cognitive, visual acuity and hearing impairment
The absence of immunosuppressive diseases such as AIDS and hepatitis, heart disease (MI, CHF) and diabetes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue participating in the study
Exit the patient from the hospital with personal consent before discharging by a doctor 
Lack of full participation in training sessions
Patients with ASA ≥3
Patients with BMI ≥3
Contact of each patient in the control group with each patient in the intervention group (in case of re-admission)</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in the intervention group completed the demographic and needs assessment questionnaires before surgery. Sample training was done so that prior to the beginning of the training, a questionnaire on the needs assessment of the educational priorities was determined based on the educational needs of the patient, then each person was trained according to his needs. Individual and face-to-face training was provided for 3 days from day before surgery or the same day until the day of discharge per day for 15-20 minutes at patient's tolerance and capacity, and a manual was provided to patients in the intervention group . Patient education was also conducted by telephoning and meeting the patient's needs by answering his questions and ambiguities by availability of the researcher (telephone number was provided to the patients) at the time of discharge and telephone answering. And the researcher himself also contacted the patient every week and ensure patient follow up and answer the patient's questions.</i_keyword>
      <i_keyword>Control group: Patients in the preoperative control group completed the demographic information and needle assessment questionnaire. Patients in the control group received only regular training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post knee joint surgery complications. Timepoint: Measurement of three common postoperative complications at the end of hospitalization time and one month after surgery during the first week of contact with the patient, the first referral of the patient to the office during the second week, the second week by contact with the patient, The second visit to the office during the fourth week, the third week and the fourth week by contact with the patient. Method of measurement: Assessing the patients' file, physician information, telephone to patients.</prim_outcome>
      <prim_outcome>The patients' educational needs. Timepoint: Before surgery and one month after surgery. Method of measurement: A researcher-made questionnaire called the need-assessment questionnaire for knee replacement subjects.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-09</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Iran University of Medical Sciences, Valiasr St.,Shahid Rashid Yasemi St . Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
