<?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>IRCT20200514047435N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-19</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>positive thinking training on stress, anxiety, depression and quality of life of hemodialysis patients</public_title>
      <acronym>PTTSADQOL</acronym>
      <scientific_title>The effect of positive thinking training on stress, anxiety, depression and quality of life of hemodialysis patients: A randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48137</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Four-dimensional block randomization
In this way, two patients from the intervention group and two patients from the control group are numbered in the four blocks and randomly assigned to the intervention and control groups, and this is done until all the blocks are finished.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Quality of life, Stress, anxiety and depression of hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Positive training program was developed based on research and positive intervention programs, as well as internal and external studies in the field of positive education .The positive training program was held in the form of 8 sessions of 90-minute and 2 sessions per week. The main topics included familiarity with the meaning of positive thinking, positive and negative thinking and the role of emotions in relationships with others, awareness of one's abilities, familiarity with relaxation techniques and attention to one's strengths, as well as ability to control one's inner and outer control in dealing with problems. 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 positive thinking content in the form of a 2-day workshop. To hold the workshops, the intervention groups were divided into smaller groups of 7 people.The 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 next sessions commenced with  a review of the topics of the previous session. Multimedia facilities such as computers, videos, and software players (PowerPoint) were used to provide training and  prevent tiredness in the participants; also, catering and short breaks were used. One week after the end of the intervention, stress, anxiety, depression, and quality of life questionnaires were filled out by the participants in both groups. Intervention 2: Control group: There is no intervention on them.</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 No further information is available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shima Sheidaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No10, Resalet Blvd</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461797511</zip>
        <telephone>0098 53333541</telephone>
        <email>Sh.amir1390@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shima Sheidaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No10,Resalat Blvd</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7461797511</zip>
        <telephone>+98 71 5333 3541</telephone>
        <email>Sh.amir1390@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>willingness to participate in the study
age 18-70 years
end-stage renal disease and under hemodialysis
a history of hemodialysis for at least 12 months or more
lack of participation in other training courses at the same time</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of participate in  positive thinking training
treatment with psychotropic drugs</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>Intervention group: Positive training program was developed based on research and positive intervention programs, as well as internal and external studies in the field of positive education .The positive training program was held in the form of 8 sessions of 90-minute and 2 sessions per week. The main topics included familiarity with the meaning of positive thinking, positive and negative thinking and the role of emotions in relationships with others, awareness of one's abilities, familiarity with relaxation techniques and attention to one's strengths, as well as ability to control one's inner and outer control in dealing with problems. 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 positive thinking content in the form of a 2-day workshop. To hold the workshops, the intervention groups were divided into smaller groups of 7 people.The 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 next sessions commenced with  a review of the topics of the previous session. Multimedia facilities such as computers, videos, and software players (PowerPoint) were used to provide training and  prevent tiredness in the participants; also, catering and short breaks were used. One week after the end of the intervention, stress, anxiety, depression, and quality of life questionnaires were filled out by the participants in both groups.</i_keyword>
      <i_keyword>Control group: There is no intervention on them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress score based on dass-21 questionnaire. Timepoint: One week after the intervention. Method of measurement: dass-21 questionnaire.</prim_outcome>
      <prim_outcome>Depression score based on dass-21 questionnaire. Timepoint: One week after the intervention. Method of measurement: dass-21 questionnaire.</prim_outcome>
      <prim_outcome>Anxiety score based on dass-21 questionnaire. Timepoint: One week after the intervention. Method of measurement: dass-21 questionnaire.</prim_outcome>
      <prim_outcome>Quality of life based on QOL-sf36 questionnaire. Timepoint: One week after the end of the intervention. Method of measurement: SF-36 Quality of Life 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-27</approval_date>
        <contact_name>Shiraz University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Namazi Square, zand street fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
