<?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>IRCT20200414047074N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-27</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of resilience Training on the Quality of Life, Depression, Stress and Anxiety in Hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of resilience Training on the Quality of Life, Depression, Stress and Anxiety in Hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47191</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block randomization method
In this study, the quadratic blocking method with a size of four was used in such a way that "training and control groups were named in groups A and B, each participant was given a short code," and two people were randomly assigned each time. Group A Two members of Group B are assigned to the four blocks, this continues until all participants are assigned to the blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Educational effectiveness.</hc_freetext>
      <i_freetext>Intervention 1: In order to develop a resilience education program, we reviewed research and resilience enhancement programs that had previously been conducted for different groups, as well as internal and external studies on resilience(29-33). Then, it was approved by the teachers of Fars University of Medical Sciences who had academic and clinical experience in this field. The intervention group received 12 sessions of training workshops on resilience skills.  The control group did not receive any training during the research, but after completing it, in order to observe the principles of ethics in research, they were taught  resilience content in the form of a 2-day workshop. To hold the workshops, the intervention groups were divided into smaller groups of 10 people. Training sessions were held by a clinical psychologist through  lectures, discussions and group participation, modeling and role-playing, intellectual challenge, staging and homework; at the end of each session, the participants' questions were answered and the beginning of the next  sessions was accompanied by a review of the topics of the previous session. In order to ensure proper productivity of the training process and also to create diversity in training, the final 10% of all training sessions were used for peer training. Peer groups are better able to encourage their peers to choose appropriate health behaviors, and they are able to share strengths and weaknesses and common experiences. Peer education is an ongoing approach in which  he/she establishes a long-term friendly and intimate relationship with the patient and shares his information with him. In order to use peer education in this study, we randomly selected 3 hemodialysis patients who were not members of the participating groups. These individuals had  at least one level of education with a diploma and appropriate expressiveness, had at least one year of hemodialysis experience, and according to the DASS-21 questionnaire, did not suffer from stress, anxiety and depression or were at a mild level. The training of the peers was such that in the presence of the instructor of the training program, under her supervision and guidance, they shared their experiences and strengths with the patients. Multimedia facilities such as computers, film and software players (PowerPoint) were used to provide training and to prevent tiredness in the participants;  also, educational videos related to resilience, catering and short breaks were used. One week after the end of the intervention, stress, anxiety, depression, and quality of life questionnaires were completed by the participants in both groups. Intervention 2: Control group: They take the pre-test and post-test but do not receive any intervention.</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:
All data except personal information is available

When:
unlimited

To whom:
unlimited

Conditions:
EDUCATIONAL

Where to obtain:
executor of plan
Mehdi Amirkhani m.amir2006@yahoo.com

How to obtain:
Send to the executor via e-mail address and receive a reply

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>MEHDI AMIRKHANI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO 10, RESALAT</address>
        <city>FASA</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461797511</zip>
        <telephone>+98 71 5333 3541</telephone>
        <email>M.AMIR2006@YAHOO.COM</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>MEHDI AMIRKHANI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>RESALAT</address>
        <city>FASA</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461797511</zip>
        <telephone>+98 71 5333 3541</telephone>
        <email>M.AMIR2006@YAHOO.COM</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age under 70 years
at least 12 months history of hemodialysis
no mental and physical problems
non-attending similar training classes</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient dissatisfaction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In order to develop a resilience education program, we reviewed research and resilience enhancement programs that had previously been conducted for different groups, as well as internal and external studies on resilience(29-33). Then, it was approved by the teachers of Fars University of Medical Sciences who had academic and clinical experience in this field. The intervention group received 12 sessions of training workshops on resilience skills.  The control group did not receive any training during the research, but after completing it, in order to observe the principles of ethics in research, they were taught  resilience content in the form of a 2-day workshop. To hold the workshops, the intervention groups were divided into smaller groups of 10 people. Training sessions were held by a clinical psychologist through  lectures, discussions and group participation, modeling and role-playing, intellectual challenge, staging and homework; at the end of each session, the participants' questions were answered and the beginning of the next  sessions was accompanied by a review of the topics of the previous session. In order to ensure proper productivity of the training process and also to create diversity in training, the final 10% of all training sessions were used for peer training. Peer groups are better able to encourage their peers to choose appropriate health behaviors, and they are able to share strengths and weaknesses and common experiences. Peer education is an ongoing approach in which  he/she establishes a long-term friendly and intimate relationship with the patient and shares his information with him. In order to use peer education in this study, we randomly selected 3 hemodialysis patients who were not members of the participating groups. These individuals had  at least one level of education with a diploma and appropriate expressiveness, had at least one year of hemodialysis experience, and according to the DASS-21 questionnaire, did not suffer from stress, anxiety and depression or were at a mild level. The training of the peers was such that in the presence of the instructor of the training program, under her supervision and guidance, they shared their experiences and strengths with the patients. Multimedia facilities such as computers, film and software players (PowerPoint) were used to provide training and to prevent tiredness in the participants;  also, educational videos related to resilience, catering and short breaks were used. One week after the end of the intervention, stress, anxiety, depression, and quality of life questionnaires were completed by the participants in both groups</i_keyword>
      <i_keyword>Control group: They take the pre-test and post-test but do not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>QUALITY OF LIFE. Timepoint: One week after training. Method of measurement: QUESTIONER.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-30</approval_date>
        <contact_name>Shiraz University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>ZAND SHIRAZ Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
