<?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>IRCT20210724051973N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-29</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of care application on pain and motor rehabilitation of patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of care application on pain and motor rehabilitation of patients after knee arthroplasty Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58326</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The random selection of people in this study will be such that using random number generator software according to CONSORT 2010, someone outside the study enters the number of sample volumes in this software and its output includes one hundred irregular numbers, half of which The numbers are in the sample group and the other half are in the control group. Clinical self-examination is a study to evaluate the treatment and special care measures such as surgery, education or preventive methods. They are randomly assigned to the experimental and control groups, Blinding description: In this method, blinding is used to prevent bias caused by interventions. In general, blinding controls the confounding factors. In the one-way blind method, the sample or intervener is not aware of the intervention method. This study is one-sided so that all subjects in the case group or in the control group must first fill in the initial demographic form of the application via the researcher's mobile phone, then all the information of the two groups is recorded in the application and individuals Those in the case group receive the application, and those in the control group receive routine hospital training. Thus, people do not know in which group of training they are.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mobile application.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: application-In this study, for the case group, an application with Android user interface has been designed by Puzzle Software Company, which has educational contents in the form of text, images and audio, and its educational content includes: post-arthroplasty care of the knee (how Doing daily tasks such as sitting and getting up correctly, how to bathe and wash, how to get in and out of the car), nutrition (introduction of a set of nutrient-rich substances such as protein, iron, calcium And vitamins, fiber, water, omega-3s and zinc), physiotherapy movements (including movements that strengthen the muscles around the knee, such as quadriceps movement, heel slide movement, ankle movements such as squeezing the accelerator pedal, bending the knee, lifting exercises Foot) to collect these materials from the phd physiotherapist, physiotherapist and doctor of sports nutrition and use valid articles and finally approved by an orthopedic specialist. Intervention 2: Control group: Routine hospital care-The control group performed routine hospital care on a face-to-face basis performed by ward nurses, which included training on how to perform routine chores at home (bathing and toilet, how to sit and stand, etc.), how to wash the surgical site. , Will receive the correct use of walkers and mobility aids.</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 I have not decided to publish yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Salehinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farahabad</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815733971</zip>
        <telephone>+98 11 3304 4000</telephone>
        <email>rezaotg@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Houshang Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farahabad</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815733971</zip>
        <telephone>+98 11 3304 4000</telephone>
        <email>rezaotg@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants are available if they meet the inclusion criteria (including having a smartphone, reading and writing literacy, age over 18, normal body mass index (since body mass index affects the function and severity of lower body joint pain) Candidate for complete knee arthroplasty for the first time and non-traumatic patient</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria (including reluctance of the patient and her companions to enter the study, inability to read and write, lack of mobile phone, lack of normal body mass index) are</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: application-In this study, for the case group, an application with Android user interface has been designed by Puzzle Software Company, which has educational contents in the form of text, images and audio, and its educational content includes: post-arthroplasty care of the knee (how Doing daily tasks such as sitting and getting up correctly, how to bathe and wash, how to get in and out of the car), nutrition (introduction of a set of nutrient-rich substances such as protein, iron, calcium And vitamins, fiber, water, omega-3s and zinc), physiotherapy movements (including movements that strengthen the muscles around the knee, such as quadriceps movement, heel slide movement, ankle movements such as squeezing the accelerator pedal, bending the knee, lifting exercises Foot) to collect these materials from the phd physiotherapist, physiotherapist and doctor of sports nutrition and use valid articles and finally approved by an orthopedic specialist</i_keyword>
      <i_keyword>Control group: Routine hospital care-The control group performed routine hospital care on a face-to-face basis performed by ward nurses, which included training on how to perform routine chores at home (bathing and toilet, how to sit and stand, etc.), how to wash the surgical site. , Will receive the correct use of walkers and mobility aids.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain and rehabilitation. Timepoint: A week. Method of measurement: 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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-13</approval_date>
        <contact_name>Research Ethics Committees of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Farahabad Street Mazandaran Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
