<?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>IRCT20260725070340N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-01</date_registration>
      <primary_sponsor>Gerash University of Medical Sciences</primary_sponsor>
      <public_title>he Effect of Narrative Reminiscence on Care Burden and Resilience among Hemodialysis Patients and their Family Caregivers</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Narrative Reminiscence Intervention on Care Burden and Resilience among Hemodialysis Patients and their Family Caregivers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92053</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: "Randomized block randomization was used to allocate the participants. A total of 16 blocks, each containing four allocations, were considered for the randomization process. Within each block, the sequence of allocations was randomly arranged. After determining the blocks and their sequences, the starting block was selected using a die (e.g., block 5). Subsequently, participants (or pairs) were assigned to the predetermined sequence groups according to their order of entry into the study, beginning with block number 5. The randomization procedure was performed using the Random Allocation Software, version 2.</study_design>
      <phase>3</phase>
      <hc_freetext>Hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants receive a structured group reminiscence protocol. This protocol involves narrating one's life story from childhood to the present day, covering topics such as school, occupation, marriage, children, and leisure activities (including travel, cooking, gardening, and pets/animals). Intervention 2: Control group: The control group did not receive any additional training and only received the routine standard education provided by the hemodialysis centers.</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 more information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gerash University of Medical Sciences, Student Boulevard, Imam Hossein (AS) Boulevard, Gerash, Fars Province, Iran</address>
        <city>Gerash</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7441758666</zip>
        <telephone>+98 71 5244 8105</telephone>
        <email>fateme25671@gmail.com</email>
        <affiliation>Gerash University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mehdi Mohsenzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gerash University of Medical Sciences, Daneshjoo Boulevard, Imam Hossein Boulevard</address>
        <city>Gerash</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7441758666</zip>
        <telephone>+98 71 5244 8105</telephone>
        <email>mohsenzadeh@gerums.ac.ir</email>
        <affiliation>Gerash University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The samples should demonstrate voluntary willingness to participate in the research
Participants should require hemodialysis due to chronic kidney disease
Patients should be familiar with the Persian language
Patients should have no history of prior kidney transplantation
Patients should be at least 18 years of age.
Patients should have the physical and mental readiness to answer the questions
Patients should have no history of mental illness or use of psychiatric medications.
The caregiver should have a family relationship with the patient.
The caregiver should have been responsible for the care of the hemodialysis patient for at least one year (based on the patient's report)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Occurrence of any social or family crisis during the study.
Absence from more than one session
Unwillingness of the patients to continue participation in the research
Hospitalization of the patient due to disease recurrence or transplant surgery
Death of the patient during the study stages
Withdrawal of the individual from continued cooperation with the research team during the study
The caregiver developing serious physical problems during the study to the extent that they lose their ability to care for the patient
Failure of the designated caregiver to participate in two or more sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for care involving renal dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants receive a structured group reminiscence protocol. This protocol involves narrating one's life story from childhood to the present day, covering topics such as school, occupation, marriage, children, and leisure activities (including travel, cooking, gardening, and pets/animals).</i_keyword>
      <i_keyword>Control group: The control group did not receive any additional training and only received the routine standard education provided by the hemodialysis centers</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Care Burden. Timepoint: Before, immediately after, and one month after the intervention. Method of measurement: Novak &amp; Guest Caregiver Burden Inventory - CBI.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Resilience. Timepoint: Before, immediately after, and one month after the intervention. Method of measurement: Connor-Davidson Resilience Scale.</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>Gerash University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-02-24</approval_date>
        <contact_name>Ethics committee of Gerash University of Medical Sciences</contact_name>
        <contact_address>Gerash University of Medical sciences, Student Blv, Imam Hussain (AS) Blv, Gerash, Fars Province, Iran Gerash Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
