<?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>IRCT20181216041997N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-25</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational supportive group therapy on quality of life</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effect of educational supportive group therapy on hemodialysis patients' quality of life</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36017</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Quality of Life.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: Group therapy with supportive-educative approach was performed in 8 sessions(70-80 min) twice a week for intervention group( 15 members groups).The sessions content was based on credible papers and sources on the assessment of quality of life in hemodialysis patients. Cognitive counseling techniques including emotional venting, interpersonal learning, self-awareness, clarification, restatement, reflection, self-awareness, role playing, and rotational and purposeful questions were used.Session 1: pretest, introduction and familiarization, clarifying the objectives of the sessions and the general structure, discussing the expectations, discussing the role of self-care and self-awareness in recovery process, and listening to the participants problems. Session 2: giving lecture and group discussion about chronic renal failure, hemodialysis, life with hemodialysis, giving time to the patients to express their feelings, viewpoints, and concerns, and answering the patients’ questions through group discussion. Home assignment: each patient was needed to report their experience with general health problems. Session 3: group discussion about the physical and mental side-effects of dialysis, prevention, and treatment, coping and attenuating the side-effects to preserve one’s social role and giving feedback to patients. Home assignment: To record one’s concerns and problems about everyday activities and interactions with others. Session 4: Group discussion about the third session home assignment and emotional and sensory intervention. This session was aimed at educating the participants about relaxation methods along with positive mental image to decease probable tensions of the day. Sessions 5 and 6: emotional and mental intervention; the main theme was to educate the participants about identifying their emotions and feelings and how to express them. In addition, the participants were encouraged to vent their suppressed emotions and feelings and in return the instructor and group members showed they sympathy and gave feedback. In addition, the importance of being independent, self-care, quality of social interactions, having a positive and good feeling, spiritual beliefs, and the role of pain and agony in life and the constructive effect of spiritual beliefs in alleviation of pains were reminded to the participants. Session 7: Spiritual interventions; the main theme of this session was care from spiritual viewpoint. The role of pain and agony in life and its constructive effect and development and expansion of ethical merits were examined. The relationships of man and nature, man and God, and man and the environment were also discussed. Session 8: Summarizing, concluding, answering the participants’ questions, and giving a general review of the previous session. Before concluding the course, the authors showed their gratitude to the participants. Intervention 2: Control group: The patients of control group received only the usual interventions in the ward  and no intervention was made by the researcher.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>AmirJalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dolatabad</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>657889909</zip>
        <telephone>+98 83 3816 2181</telephone>
        <email>a_jalali@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Jalali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dolatabad</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>657889909</zip>
        <telephone>+98 83 3816 2181</telephone>
        <email>a_jalali@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have a history of hemodialysis for more than 6 months.
Have a desire to participate in research.
Be able to read and write.
Age 18 to 65 years.</inclusion_criteria>
      <agemin>32 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of attending similar classes
History of kidney transplantation
Existence of physical disabilities such as deafness, blindness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 4 (severe)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group: Group therapy with supportive-educative approach was performed in 8 sessions(70-80 min) twice a week for intervention group( 15 members groups).The sessions content was based on credible papers and sources on the assessment of quality of life in hemodialysis patients. Cognitive counseling techniques including emotional venting, interpersonal learning, self-awareness, clarification, restatement, reflection, self-awareness, role playing, and rotational and purposeful questions were used.Session 1: pretest, introduction and familiarization, clarifying the objectives of the sessions and the general structure, discussing the expectations, discussing the role of self-care and self-awareness in recovery process, and listening to the participants problems. Session 2: giving lecture and group discussion about chronic renal failure, hemodialysis, life with hemodialysis, giving time to the patients to express their feelings, viewpoints, and concerns, and answering the patients’ questions through group discussion. Home assignment: each patient was needed to report their experience with general health problems. Session 3: group discussion about the physical and mental side-effects of dialysis, prevention, and treatment, coping and attenuating the side-effects to preserve one’s social role and giving feedback to patients. Home assignment: To record one’s concerns and problems about everyday activities and interactions with others. Session 4: Group discussion about the third session home assignment and emotional and sensory intervention. This session was aimed at educating the participants about relaxation methods along with positive mental image to decease probable tensions of the day. Sessions 5 and 6: emotional and mental intervention; the main theme was to educate the participants about identifying their emotions and feelings and how to express them. In addition, the participants were encouraged to vent their suppressed emotions and feelings and in return the instructor and group members showed they sympathy and gave feedback. In addition, the importance of being independent, self-care, quality of social interactions, having a positive and good feeling, spiritual beliefs, and the role of pain and agony in life and the constructive effect of spiritual beliefs in alleviation of pains were reminded to the participants. Session 7: Spiritual interventions; the main theme of this session was care from spiritual viewpoint. The role of pain and agony in life and its constructive effect and development and expansion of ethical merits were examined. The relationships of man and nature, man and God, and man and the environment were also discussed. Session 8: Summarizing, concluding, answering the participants’ questions, and giving a general review of the previous session. Before concluding the course, the authors showed their gratitude to the participants.</i_keyword>
      <i_keyword>Control group: The patients of control group received only the usual interventions in the ward  and no intervention was made by the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before; Immediately after ; A month later. Method of measurement: Kidney disease 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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-08</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Beheshti ave. Kermanshah University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
