<?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>IRCT20180728040617N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-12</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The effect of multimedia education based on stress management program on quality of life and self-care behaviors of hemodialysis patients: a parallel randomized clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>The effect of multimedia education based on stress management program on quality of life and self-care behaviors of hemodialysis patients: a parallel randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75289</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be divided into intervention and control groups by random block allocation using quadruple blocks created by SPSS software. According to the sample size of 64 in the present study, 16 quadruple blocks will be considered. Each patient will be randomly assigned to Group A (intervention) or B (control group) in the order determined by the software, and the allocation and sampling process will be performed sequentially until sampling is completed. Individuals are assigned to the target group in order of their entry into the study and randomly through randomized blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will participate in six online sessions featuring multimedia educational content. This content includes educational support covering hemodialysis, diet, medications, and physical activity, along with a stress management program based on Lazarus and Folkman's theoretical model. The stress management program will encompass education on stress and its influencing factors, assistance for patients in identifying counterproductive stress-inducing thoughts, provision of problem-oriented and emotion-oriented solutions for managing stress, and support for the application of stress management techniques in daily life.Data Collection Tools: Data collection tools will include a demographic information form, the Miller Self-Care Behavior Questionnaire, and the World Health Organization Quality of Life Questionnaire. These questionnaires will be completed by all patients (both the intervention and control groups) before the intervention, prior to the first session. Subsequently, one month after the conclusion of the intervention, the same questionnaires will be completed to assess the effectiveness of the intervention. Intervention 2: Control group: The control group will receive routine support from the treatment center. Supportive content will be provided to the control group after the 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:
Certain demographic information of patients can be shared after de-identifying the individuals. Additionally, all data related to assessing the quality of life and self-care behaviors of patients can also be shared after unidentified individuals.

When:
After publishing the article

To whom:
Project partners

Conditions:
People who do similar research.

Where to obtain:
Requests to receive documents are sent to the project's principal investigator (Ali Abbasi) via email (abbasi_msn@yahoo.com). Address: Tehran St., Shahroud University of Medical Sciences, Shahroud, Iran. Contact number: 00982332395054, postal code: 3614773955

How to obtain:
After receiving the request, the data will be provided to the applicants by the project manager immediately via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Khajoei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773947</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>sara13721400@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773947</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>abbasi_msn@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age above 18 years
Definitive diagnosis of end stage renal disease by a specialist
Ability to use a smartphone
Experience of at least 1 year of hemodialysis
Undergoing hemodialysis 2 to 3 times a week</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having psychiatric disorders
Neuroleptics medications
Occurrence of traumatic events for the patient less than six months before the intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y84.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Kidney dialysis as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will participate in six online sessions featuring multimedia educational content. This content includes educational support covering hemodialysis, diet, medications, and physical activity, along with a stress management program based on Lazarus and Folkman's theoretical model. The stress management program will encompass education on stress and its influencing factors, assistance for patients in identifying counterproductive stress-inducing thoughts, provision of problem-oriented and emotion-oriented solutions for managing stress, and support for the application of stress management techniques in daily life.Data Collection Tools: Data collection tools will include a demographic information form, the Miller Self-Care Behavior Questionnaire, and the World Health Organization Quality of Life Questionnaire. These questionnaires will be completed by all patients (both the intervention and control groups) before the intervention, prior to the first session. Subsequently, one month after the conclusion of the intervention, the same questionnaires will be completed to assess the effectiveness of the intervention.</i_keyword>
      <i_keyword>Control group: The control group will receive routine support from the treatment center. Supportive content will be provided to the control group after the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: At the beginning of the study (before the intervention) and a month after intervention. Method of measurement: World Health Organization Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Self-care behaviors. Timepoint: At the beginning of the study (before the intervention) and a month after intervention. Method of measurement: Miller self-care behavior 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-10</approval_date>
        <contact_name>Ethics Committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran. Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
