<?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>IRCT20220803055608N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-29</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of recreational therapy application on fatigue and depression in hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of recreational therapy application on fatigue and depression in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65151</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization is done using the www.randomization.com site and the random sequences determined using a closet envelope are allocated to the study participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: End stage renal disease. Condition 2: Depression. Condition 3: Chronic kidney disease (CKD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After stating the objectives and obtaining informed consent from the samples, the patients are assured about the confidentiality of the information and publication of the results of the studies. Then the patients personal and medical characteristics, becks depression and MFI fatigue questionnaires are completed. After preparing and confirming the content of the recreational therapy application, in consultation with the informatics engineer the application will be prepared for the smartphone as standard in the android operating system. Then the application is installed on the patients mobile phone and patients is taught how to use it. Patients will perform all the programs specified in the application every day for 30 days. Using a checklist and based on the characteristics and date of entry into the study, the researcher will follow up the patients on a daily basis through phone calls and also in person in term of the full implementation of the determined programs. After 30 days, Becks depression and MFI fatigue questionnaires will be completed again for patients. Intervention 2: Control group: After stating the objectives and obtaining informed consent from the samples, the patients are assured about the confidentiality of the information and publication of the results of the studies. Then the patients personal and medical characteristics, becks depression and MFI fatigue questionnaires are completed. In this group, no intervention was performed nd only routine hospital nursing interventions were provided, including checking vital signs and injecting prescription drugs. After 30days, Becks depression and MFI fatigue questionnaires are completed.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Moein Alishahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Ebne sina Street, Doctora Crossroad, Daneshgah Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Moeinnurse@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Moein Alishahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Ebne sina Street, Doctora Crossroad, Daneshgah Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Moeinnurse@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 60 years
Having full consciousness
Having a mobile phone under the Android operating system
A history of at least 2 months of hemodialysis
Perform hemodialysis at least 2 to 3 times a week
Not taking anti depression or drugs that effect
Not having a history of mental illness according to the patients statement or a history of taking psychiatric drugs</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
Occurrence of physical and mental disorders requiring treatment or hospitalization
Death or travel of the participant during the research
Failure to implement approved programs for at least 10 days
Obtaining a score higher than 19 studies of the Beck depression questionnaire</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.6</hc_code>
      <hc_code>F06.31</hc_code>
      <hc_code>N18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>End stage renal disease</hc_keyword>
      <hc_keyword>Mood disorder due to known physiological condition with depressive features</hc_keyword>
      <hc_keyword>Chronic kidney disease (CKD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After stating the objectives and obtaining informed consent from the samples, the patients are assured about the confidentiality of the information and publication of the results of the studies. Then the patients personal and medical characteristics, becks depression and MFI fatigue questionnaires are completed. After preparing and confirming the content of the recreational therapy application, in consultation with the informatics engineer the application will be prepared for the smartphone as standard in the android operating system. Then the application is installed on the patients mobile phone and patients is taught how to use it. Patients will perform all the programs specified in the application every day for 30 days. Using a checklist and based on the characteristics and date of entry into the study, the researcher will follow up the patients on a daily basis through phone calls and also in person in term of the full implementation of the determined programs. After 30 days, Becks depression and MFI fatigue questionnaires will be completed again for patients.</i_keyword>
      <i_keyword>Control group: After stating the objectives and obtaining informed consent from the samples, the patients are assured about the confidentiality of the information and publication of the results of the studies. Then the patients personal and medical characteristics, becks depression and MFI fatigue questionnaires are completed. In this group, no intervention was performed nd only routine hospital nursing interventions were provided, including checking vital signs and injecting prescription drugs. After 30days, Becks depression and MFI fatigue questionnaires are completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in Beck questionnaire. Timepoint: The beginnings of study (Before the start of the intervention) and 30 days after the start of the intervention. Method of measurement: Beck depression questionnaire.</prim_outcome>
      <prim_outcome>Fatigue score in Multidimensional Fatigue Inventory (MFI) questionnaire. Timepoint: The beginnings of study (Before the start of the intervention) and 30 days after the start of the intervention. Method of measurement: Multidimensional Fatigue Inventory (MFI) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea. Timepoint: The beginnings of study (Before the start of the intervention) and 30 days after the start of the intervention. Method of measurement: Verbal numeric rate scale (VNRS).</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: The beginnings of study (Before the start of the intervention) and 30 days after the start of the intervention. Method of measurement: Kidney disease quality of life (KDQOL-SF).</sec_outcome>
      <sec_outcome>Perceived stress. Timepoint: The beginnings of study (Before the start of the intervention) and 30 days after the start of the intervention. Method of measurement: Cohen perceived stress 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-22</approval_date>
        <contact_name>Ethics Committee of Mashhad School of Nursing and Midwifery</contact_name>
        <contact_address>Qureshi building, Next to hoveyze cinema, Daneshgah street. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
