<?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>IRCT20231030059902N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-20</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of implementation of sleep hygiene program on self-care behavior of patients with heart failure</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of implementation of sleep hygiene program on self-care behavior of patients with heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73768</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: All stages of the sleep hygiene program are performed using a comprehensive sleep hygiene booklet designed by myself, and the patient has a dynamic role in the program, Randomization description: After completing the study tool by each patient; In the next step, by giving an identification code to each of the patients and using a subsidized random selection software (random number generation kit set online), the patients participating in the study are assigned to two control and intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart failure disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:For the intervention group, a notebook titled "Comprehensive Sleep Health Program Notebook" was prepared by the researcher, which includes five training sessions for five weeks, three sessions are held in person and two sessions are held virtually in Iranian ETA messengers. Necessary trainings are provided and Questions and answers will be held and educational sessions will include: explanation and explanation of the phenomenon of sleep and its role in health and illness, familiarization with various types of sleep disorders and improving factors, sleep quantity and quality Daily stress management and spiritual interventions improve sleep, and face-to-face training sessions are conducted using comprehensive sleep hygiene booklets, video projectors and slides, and virtual sessions using text, video, and podcasts. Intervention 2: Control group:There is no intervention and they receive routine training during discharge, and if the interventions performed on the intervention group are effective, all the training will be given to the control group at the end of the research.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hasan Allahyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th floor, unit 27, Reza building, next to Afar Korosh street, Firozabad, Fars province, Iran</address>
        <city>Firoozabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7471643875</zip>
        <telephone>+98 71 3873 5374</telephone>
        <email>allahyari814@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Rasol Eslamiakbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jahrom University of Medical Sciences،Jahrom،Fars Province,Iran</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>+98 71 5434 0405</telephone>
        <email>eslamiakbarrasool@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least one year has passed since the patient's heart failure diagnosis
Class II or III heart failure patients
Nativeness of patients with heart failure
Being in the age group of 35 to 55 years
Not taking sedative or hypnotic drugs at the time of entering the study
Having the ability to communicate and being literate
Ability to perform self-care
No consumption of alcohol and drugs
Not having other chronic physical and mental disorders, including chronic kidney failure, liver failure, diabetes, or mental disorders such as major depression and other psychotic disorders.
Claim to have sleep problems</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>death of the patient
The death of family members or other first -class relatives during the study of the study
Taking sedative or sleeping medications during intervention
The creation of any adverse event that causes the patient's severe stress and anxiety at the time of study
The patient's unwillingness to continue studying or not attending educational sessions for more than one session</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Heart failure, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:For the intervention group, a notebook titled "Comprehensive Sleep Health Program Notebook" was prepared by the researcher, which includes five training sessions for five weeks, three sessions are held in person and two sessions are held virtually in Iranian ETA messengers. Necessary trainings are provided and Questions and answers will be held and educational sessions will include: explanation and explanation of the phenomenon of sleep and its role in health and illness, familiarization with various types of sleep disorders and improving factors, sleep quantity and quality Daily stress management and spiritual interventions improve sleep, and face-to-face training sessions are conducted using comprehensive sleep hygiene booklets, video projectors and slides, and virtual sessions using text, video, and podcasts.</i_keyword>
      <i_keyword>Control group:There is no intervention and they receive routine training during discharge, and if the interventions performed on the intervention group are effective, all the training will be given to the control group at the end of the research.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self care. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Jarsma's European questionnaire of self-care behaviors.</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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-27</approval_date>
        <contact_name>Research Ethics Committee of Jahrom University of Medical Sciences</contact_name>
        <contact_address>5th floor, unit 27, Reza building, next to Afar Korosh street, Firozabad, Fars province, Iran Firoozabad Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
