<?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>IRCT20140212016564N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-08</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect  of life story intervention on psychological well-being</public_title>
      <acronym></acronym>
      <scientific_title>The effect of life story intervention on psychological well-being of elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49304</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Two nursing homes in Urmia, which are similar in social and cultural environment, will be selected and randomly selected by one of these nursing homes as a control group and the other as an intervention group. Then, from the inside of the nursing home, which is selected as an intervention group, 30 elderly people are randomly selected and placed in the intervention group, and will be placed in three groups of 10 people to perform the intervention. The 30 elderly are randomly selected and placed in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>psychological well-being of elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:30 elderly people will be randomly selected and placed in the intervention group and will be placed in three groups of 10 people to perform the intervention. The intervention will be performed in six sessions of 60 minutes and once a week  based on a life review treatment program with emphasis on Erickson theory on the intervention group.The meeting place will be in a quiet room with enough light where the chairs will be arranged in a circle. The review program is based on the life theory with emphasis on Erickson theory According to the reference book of art and science of reminiscing of Webster and Haight is:  Session 1: Welcoming members, introducing members to each other, reviewing goals and listing members' problems - 60 minutes   Session 2: Explain childhood memories and resolve unresolved conflicts of that period by discussing these issues in the group (Basic Trust vs. Distrust)  (Autonomy against doubt and shame (.- 60 minutes    Homework for the next session: (The elderly are asked to write the homework for the next session on a piece of paper if they are literate and otherwise prepare the answers to say in the next session.  Session 3: Review of homework: Then review the memories of adolescence and resolve unresolved conflicts of that period by discussing these issues in the group .Identity versus role confusion (Intimacy versus isolation)  -60 minutesHomework for the next session.   Session 4: After reviewing the assignments and topics of the previous session, reviewing the memories of your youth and resolving the unresolved conflicts of that period by discussing these issues in the group: (Fertility against recession) - 60 minutes. Homework for the next session. Session 5: After reviewing the assignments and topics of the previous session, reviewing the memories of middle age and resolving the unresolved conflicts of that period by discussing these issues in the group,-60 minutes.  Session 6: Summary: Discuss these topics in the group -60 minutes. Intervention 2: Control group: The control group received no 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:
The whole data will be shared after being unidentified

When:
Start the access period 6 months after printing the results

To whom:
Researchers working in academia

Conditions:
The data will be available to other researchers in the form of a printed article. Other researchers are allowed from the research team to use the data

Where to obtain:
Radfar moloud Email:mradfar1343@gmail.com

How to obtain:
You will submit your application to Mrs. Radfar, who will send you the requested application within ten days after reviewing your request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Moloud Radfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia faculty of Nursing and Midwifery</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714995143</zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>mradfar1343@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Moloud Radfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia faculty of Nursing and Midwifery</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>mradfar1343@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 65 years and older
the ability to attend class
conscious consent to participate in the research</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>have an acute psychiatric problem according to the case</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>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:30 elderly people will be randomly selected and placed in the intervention group and will be placed in three groups of 10 people to perform the intervention. The intervention will be performed in six sessions of 60 minutes and once a week  based on a life review treatment program with emphasis on Erickson theory on the intervention group.The meeting place will be in a quiet room with enough light where the chairs will be arranged in a circle. The review program is based on the life theory with emphasis on Erickson theory According to the reference book of art and science of reminiscing of Webster and Haight is:  Session 1: Welcoming members, introducing members to each other, reviewing goals and listing members' problems - 60 minutes   Session 2: Explain childhood memories and resolve unresolved conflicts of that period by discussing these issues in the group (Basic Trust vs. Distrust)  (Autonomy against doubt and shame (.- 60 minutes    Homework for the next session: (The elderly are asked to write the homework for the next session on a piece of paper if they are literate and otherwise prepare the answers to say in the next session.  Session 3: Review of homework: Then review the memories of adolescence and resolve unresolved conflicts of that period by discussing these issues in the group .Identity versus role confusion (Intimacy versus isolation)  -60 minutesHomework for the next session.   Session 4: After reviewing the assignments and topics of the previous session, reviewing the memories of your youth and resolving the unresolved conflicts of that period by discussing these issues in the group: (Fertility against recession) - 60 minutes. Homework for the next session. Session 5: After reviewing the assignments and topics of the previous session, reviewing the memories of middle age and resolving the unresolved conflicts of that period by discussing these issues in the group,-60 minutes.  Session 6: Summary: Discuss these topics in the group -60 minutes</i_keyword>
      <i_keyword>Control group: The control group received no intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological well-being score in Ryff Questionnaire. Timepoint: Measurement of psychological well-being score before the start of the intervention and immediately after the intervention and two months later. Method of measurement: Ryff Psychological Well-being 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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-22</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Resalat boulevard, next to the emergency Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
