<?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>IRCT20190102042214N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-18</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of reminiscence in mental health in patients under hemodialysis.</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of reminiscence on the level of mental health and happiness in elderly patients under haemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36525</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: According to the type of study, randomization of the subjects in two groups, the list of these individuals was done after coding. At first, thirty items were withdrawn for the intervention group and the remaining thirty were considered for the control group. In this way, the samples were randomly allocated to the groups, Blinding description: The names of people in the spss file are coded as encoded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients under hemodialysis.</hc_freetext>
      <i_freetext>Intervention group: Memory sessions based on the Stinson protocol were held sixty-minute meetings twice a week for four weeks..</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>Aliasghar shamsabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam reza ave</address>
        <city>Bojnourd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9661764791</zip>
        <telephone>+98 58 3723 9483</telephone>
        <email>dialis.esfarayen@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>aliasghar shamsabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>khalij fars Blvd., bojnourd Town</address>
        <city>bojnourd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9661764791</zip>
        <telephone>+98 58 3723 9483</telephone>
        <email>dialis.esfarayen@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Conditions for participation in research for samples, aged over 60, having a history of dialysis for more than three months, lack of clinical diagnosis of mental illness in a hospitalized case during haemodialysis, and not receiving antidepressants and substance abuse drugs, lack of participation in psychological groups and desire To enter the study.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The elderly participated in the emergence of signs and symptoms of the crisis during the review of the occurrence of life, the absence of three sessions of research and the reluctance of individuals to continue to cooperate with the sample.</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Memory sessions based on the Stinson protocol were held sixty-minute meetings twice a week for four weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Beck Depression Inventory framework is made up of 29 items of four items (20 items from the previous scale and 9 items revised), which is answered on a six-point Likert Scale. Oxford Happiness Scale A new form (OHQ) for each question is a score of 1 to 6, for each component a score and for the entire test, also a score that indicates the level of happiness of the person. The highest score one person can receive in this questionnaire is 174 and the lowest is 29. Higher scores mean more happiness. Timepoint: The assessment will be carried out before and after the intervention. After one month, follow up. Method of measurement: Demographics, general health and happiness questionnaires of Oxford were completed by all individuals and their mean score was considered as the mean of pre-test scores. In order to hold memorization sessions, the necessary coordination was done with each group of interventions. The memorable sessions were then held for four weeks at sixty-minute meetings twice a week, according to the Stinson Protocol. The first meeting began with the introduction of contributors to each other by their own. The researcher also provided information on his work and merits to get closer to the participants, then on the concepts used in each session and the preparation for each session. Meetings were organized with specific topics, and people focused on different items during the recounting of memories in each session. The topics of the memorial sessions are such as childhood memories, the presentation of the memories of the period of education, the talk about the memories of youth and soldiers, the recollection of the memories of the marriage and the birth of children, talking about memories from parents and friends, expressing memories of holidays, travels and experiences. Job was the talk of the special and important events of the past. The sessions were run by a researcher and a dialysis nurse and the facilitator facilitated the group's interaction during the sessions. Patients were encouraged to recall memories and discussions. The people, with the help of the researcher, after the end of each discussion, interpreted and evaluated the material, meaning what they had been doing and merged them with their present life. At the end of each session, the subject of the next meeting was also reminded, and the participants were advised to be prepared for the subject of the next meeting. The last meeting participants talked about their experiences with the group and shared their latest memories about the topics discussed at the previous sessions. Summarizing and providing feedback to the researcher was done on the topics discussed at the previous sessions. At the end of the last session, Goldberg General Health and Oxford Happiness Questionnaires were again completed by the members of the group and their mean score was considered as a post-test score. During this period, care was taken for the control group, but no intervention was performed. At the end of the eighth session in the control group, the questionnaires were completed again and were considered as a post-test score. One month after the end of the sessions, the tools reviewed in the pre-test were completed in both groups.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Happiness and mental health score. Timepoint: Before intervention. After intervention. Follow up one month later. Method of measurement: Demographic information questionnaire, Goldberg General Health (GHQ-28) and Oxford Happiness (OHQ) were used for data collection.</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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-23</approval_date>
        <contact_name>Ethics committee of north khorasan University of Medical Sciences</contact_name>
        <contact_address>Emam reza ave. Bojnourd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
