<?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>IRCT20190209042659N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-22</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-care on stress, anxiety and depression in hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-care program based on Orem model on stress , anxiety and depression level in hemodialysis patients of Farabi hospital in Bastak in 2018</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37457</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Other design features: -.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Reducing stress, depression and anxiety in hemodialysis patients.</hc_freetext>
      <i_freetext>The present study is a quasi-experimental study of single-group intervention before and after studying the effects of Orem-based education curriculum on stress, anxiety and depression in hemodialysis patients. The number of 40 modal mortality patients referred to dialysis centers of Hormozgan Medical Sciences University, Farabi Hospital. Statistical population of this research The research will be carried out using the available sampling method. All patients who meet the criteria for participation in the study will be selected, and after obtaining their consent and informed written consent, which will be the Hormozgan Medical Sciences College's ethics committee,Will be studied.A DASS42 questionnaire, a demographic questionnaire and a demographic questionnaire, a demographic questionnaire completed by all patients under study, were completed by a DASS42 three-part questionnaire. The DASS42 scale is a self-report questionnaire developed by Lovibond in 1995, and the diagnostic and screening side of the signs of stress , Anxiety and depression during the past week. Studies conducted by Lewibond Shan showed that the retest reliability for sub-scales was 0.81 for stress, 0.79 for anxiety, 0.71 for depression. The scale validity of the Beck Anxiety and Depression Scale 14 with correlation coefficients was 0.71 and 0.74 respectively. Therefore, this scale has the appropriateness of applying for research and diagnostic activities.The third part of the questionnaire consisted of 20 questions about the educational needs of hemodialysis patients based on the ORM self-care model. This questionnaire was designed by Ramezani Badr and his colleagues in 1392. The validity of this questionnaire was determined through content validity and its reliability was calculated by calculating the alpha coefficient of cronbach (0.89). Scoring is based on the Likert scale and the answers to questions are high, medium, low and high, which points from the need for high education to no need for training, respectively. By convention, based on our own self-care model, the score is 10- 0, independent, 30-11, semi-dependent, and 31-60 dependent from the educational point of view. For the statistical community that has entered the study, the questions will be completed before interconnection.Then the patients will be trained for four sessions in different fields and based on their educational needs. Each training session lasts from 30 to 45 minutes and sessions within a week's time. In general, training sessions will continue for four weeks. Generally speaking, different training areas are based on the needs assessment including kidney failure, hemodialysis, fistula and catheter care, diet, sexual issues, sleep problems, anemia, activity and rest, shortness of breath, and nausea and vomiting. Be This training is given face-to-face and during dialysis.At the end of the training sessions, a booklet containing all the materials taught is given to the patients. One month, these patients will be given the opportunity to use the lessons learned in their daily activities. During this one month, patient referral was followed up by the use of trained material in everyday activities. If the self-care activities were not carried out, the cause of the study was resolved and resolved and, if continued, the sample would be excluded from the study. After a month after the intervention, the DASS questionnaire 42 is completed by patients again..</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 Maintaining the secrets of the family</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ِDr.Aref faghih</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Resalat Street, Faculty of Nursing</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>79671-34866</zip>
        <telephone>+98 76 4433 2632</telephone>
        <email>najmamina.1368@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Areffaghih</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>latResa Street, Faculty of Nursing</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>79671-34866</zip>
        <telephone>+98 76 4433 2632</telephone>
        <email>najmamina.1368@gmail.com</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Eighteen years old
Regular visits to this center
Satisfaction of the company in the research
A record of at least three months of medication</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The history of hospitalization due to psychological problems
Get the education program from the Hemodialysis Centers
To do the transplant operation during the research
Gain an independent score from a needle list</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The present study is a quasi-experimental study of single-group intervention before and after studying the effects of Orem-based education curriculum on stress, anxiety and depression in hemodialysis patients. The number of 40 modal mortality patients referred to dialysis centers of Hormozgan Medical Sciences University, Farabi Hospital. Statistical population of this research The research will be carried out using the available sampling method. All patients who meet the criteria for participation in the study will be selected, and after obtaining their consent and informed written consent, which will be the Hormozgan Medical Sciences College's ethics committee,Will be studied.A DASS42 questionnaire, a demographic questionnaire and a demographic questionnaire, a demographic questionnaire completed by all patients under study, were completed by a DASS42 three-part questionnaire. The DASS42 scale is a self-report questionnaire developed by Lovibond in 1995, and the diagnostic and screening side of the signs of stress , Anxiety and depression during the past week. Studies conducted by Lewibond Shan showed that the retest reliability for sub-scales was 0.81 for stress, 0.79 for anxiety, 0.71 for depression. The scale validity of the Beck Anxiety and Depression Scale 14 with correlation coefficients was 0.71 and 0.74 respectively. Therefore, this scale has the appropriateness of applying for research and diagnostic activities.The third part of the questionnaire consisted of 20 questions about the educational needs of hemodialysis patients based on the ORM self-care model. This questionnaire was designed by Ramezani Badr and his colleagues in 1392. The validity of this questionnaire was determined through content validity and its reliability was calculated by calculating the alpha coefficient of cronbach (0.89). Scoring is based on the Likert scale and the answers to questions are high, medium, low and high, which points from the need for high education to no need for training, respectively. By convention, based on our own self-care model, the score is 10- 0, independent, 30-11, semi-dependent, and 31-60 dependent from the educational point of view. For the statistical community that has entered the study, the questions will be completed before interconnection.Then the patients will be trained for four sessions in different fields and based on their educational needs. Each training session lasts from 30 to 45 minutes and sessions within a week's time. In general, training sessions will continue for four weeks. Generally speaking, different training areas are based on the needs assessment including kidney failure, hemodialysis, fistula and catheter care, diet, sexual issues, sleep problems, anemia, activity and rest, shortness of breath, and nausea and vomiting. Be This training is given face-to-face and during dialysis.At the end of the training sessions, a booklet containing all the materials taught is given to the patients. One month, these patients will be given the opportunity to use the lessons learned in their daily activities. During this one month, patient referral was followed up by the use of trained material in everyday activities. If the self-care activities were not carried out, the cause of the study was resolved and resolved and, if continued, the sample would be excluded from the study. After a month after the intervention, the DASS questionnaire 42 is completed by patients again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress, anxiety and depression. Timepoint: In the study of the effect of health care on hemodialysis patients, measurements were done before intervention and one month after interventio. Method of measurement: DASS42 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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-19</approval_date>
        <contact_name>Ethics Committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Resalat Street, nursing school Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
