<?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>IRCT20220327054356N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-29</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Assessment the Effect of Education on quality of caring interactions in nurses and patients in the cardiac care units</public_title>
      <acronym></acronym>
      <scientific_title>Assessment the Effect of Education on quality of caring interactions in nurses and patients in the cardiac care units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>188</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62672</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are readily available from among patients admitted to the cardiac wards of the hospital after three days of hospitalization, first selected as a pre-intervention group and again after the completion of the educational intervention on nurses, as a post-intervention group. It should be noted that 38 patients are from one cardiac ward and 38 patients are from the other ward. Nurses working in these two wards, which are a total of 36 people will be included in the study by census method and nurses of one ward will be assigned to the control group and the nurses of the other ward will be assigned to the intervention group by simple random sampling with a sealed envelope. Are given in such a way that in each envelope the name of one of the two desired cardiac sections is written and one section is randomly selected as the intervention group and the other section as the control group. In each envelope, the name of one of the two cardiac wards is written and one section is randomly selected as the intervention group and the other ward as the control group, Blinding description: The data analyzer is blind and she does not know which data is for control group and intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>quality of caring interactions in nurses and patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After describing the purpose of the study and obtaining informed consent, in the first session, the researcher presented a questionnaire including demographic characteristics of patients and caring nurse-patient interaction scale (patient-version) to patients with at least 3 days hospitalization at cardiac care units and a questionnaire including demographic characteristics of nurses and the caring nurse-patient interaction scale( nurse-version) to cardiac care unit nurses. Then the intervention by a researcher who has a bachelor of science in nursing and at least two years of experience working in cardiac care units after improving her knowledge about the effect of education on nurse-patient care interactions in a self-taught way, is provided. the training method will be as follows: To prevent the effect of nurses' behavior on each other and distort the study, nurses for intervention and control group will be chose from two different cardiac care units. The researcher then, through a group created on the social network, invites the members of the intervention group to participate in  sessions held through the WhatsApp application. The training will be provided virtually one hour a day, every other day at a specific time of the day and for one month to the nurses of the intervention group. After the approval of the research team, educational videos downloaded from reputable sites with Persian subtitles will be placed in the group, also  educational texts in Persian provided to the participants, and it should be mentioned to ensure Reading materials by nurses will send them a reminder message at a specific time. The researcher will also answer possible questions of the participants during the intervention through social networks and WhatsApp application. Questionnaires will be completed by nurses 1 month after the intervention. It is important to note that the intervention is performed only on nurses, and in order to assess the consequences of the intervention, the nurse-patient caring interaction questionnaire ( patient-version ),  will be completed by patients who have been hospitalized for at least three days and in variables Age, sex, and many other variables are matched with patients before the intervention, Before and one month after the intervention. These questionnaires will be distributed and collected by a bachelor of science in nursing who is working in that cardiac care unit. The educational content that will be presented to nurses in this study will include the content presented in nursing reference books in the field of education and caring interaction between nurses and patients. Of course, references and articles available on international sites and reputable databases will also be used. After preparing the educational content of the intervention group, which will necessarily cover the contents of different areas of the nurse-patient caring interaction questionnaire, the materials will be provided to two specialist nurses with a PhD degree from the School of Nursing who will not formally cooperate with this study And its authenticity will be ensured. In the intervention group, in addition to the usual training, professional caring interaction training (according to the protocol designed by researchers based on relevant texts and research variables) will be provided to nurses Which include: definition of caring interaction, history about it, factors which influencing on  a caring interaction, the impact of each area of ​​the questionnaire on the caring interaction and vice versa, the impact of caring interaction on various aspects of treatment and disease and strategies for creating an appropriate caring interaction. Intervention 2: Control group: After describing the purpose of the study and obtaining informed consent, in the first session, the researcher presented a questionnaire including demographic characteristics of patients and caring nurse-patient interaction scale (patient-version) to patients with at least 3 days hospitalization at cardiac care units and a questionnaire including demographic characteristics of nurses and the caring nurse-patient interaction scale( nurse-version) to cardiac care unit nurses. The questionnaires will be completed, and again one month later, These questionnaires will be distributed and collected by a bachelor of science in nursing who is working in that cardiac care unit. The nurses in the control group will receive only the usual training( routine training) , and training in The field of caring interactions will not be provided to this group. It should be noted that at the end of the intervention, the training provided to the intervention group will be provided to the nurses of the control group.</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:
All unidentifiable data of the participants, study protocol, statistical analysis map, informed consent form, clinical study report, codes used in the analysis and data classification system can be shared.

When:
Immediately  after publishing the results

To whom:
All researchers

Conditions:
The source of the research should be stated and all ethical issues should be observed.

Where to obtain:
anisbahreini1375@gmail.com

How to obtain:
After obtaining permission from all researchers, this research will be sent via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roghayeh Mehdipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haftbagh Alavi highway,Kerman University of Medical Science</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>rm41321@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roghayeh Mehdipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haftbagh Alavi highway,Kerman University of Medical Science</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>rm41321@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients should be hospitalized in cardiac wards for at least 3 days.
Patients should be at least 18 years old.
The general condition of the patient should be good.
Patients should have at least middle School degree.
Nurses must have at least 6 months of clinical experience.
Nurses must have a smartphone and WhatsApp.
Nurses must have enough time to participate  in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with dementia and psychological problems according to self-declaration
Previous hospitalization history in the heart ward</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After describing the purpose of the study and obtaining informed consent, in the first session, the researcher presented a questionnaire including demographic characteristics of patients and caring nurse-patient interaction scale (patient-version) to patients with at least 3 days hospitalization at cardiac care units and a questionnaire including demographic characteristics of nurses and the caring nurse-patient interaction scale( nurse-version) to cardiac care unit nurses. Then the intervention by a researcher who has a bachelor of science in nursing and at least two years of experience working in cardiac care units after improving her knowledge about the effect of education on nurse-patient care interactions in a self-taught way, is provided. the training method will be as follows: To prevent the effect of nurses' behavior on each other and distort the study, nurses for intervention and control group will be chose from two different cardiac care units. The researcher then, through a group created on the social network, invites the members of the intervention group to participate in  sessions held through the WhatsApp application. The training will be provided virtually one hour a day, every other day at a specific time of the day and for one month to the nurses of the intervention group. After the approval of the research team, educational videos downloaded from reputable sites with Persian subtitles will be placed in the group, also  educational texts in Persian provided to the participants, and it should be mentioned to ensure Reading materials by nurses will send them a reminder message at a specific time. The researcher will also answer possible questions of the participants during the intervention through social networks and WhatsApp application. Questionnaires will be completed by nurses 1 month after the intervention. It is important to note that the intervention is performed only on nurses, and in order to assess the consequences of the intervention, the nurse-patient caring interaction questionnaire ( patient-version ),  will be completed by patients who have been hospitalized for at least three days and in variables Age, sex, and many other variables are matched with patients before the intervention, Before and one month after the intervention. These questionnaires will be distributed and collected by a bachelor of science in nursing who is working in that cardiac care unit. The educational content that will be presented to nurses in this study will include the content presented in nursing reference books in the field of education and caring interaction between nurses and patients. Of course, references and articles available on international sites and reputable databases will also be used. After preparing the educational content of the intervention group, which will necessarily cover the contents of different areas of the nurse-patient caring interaction questionnaire, the materials will be provided to two specialist nurses with a PhD degree from the School of Nursing who will not formally cooperate with this study And its authenticity will be ensured. In the intervention group, in addition to the usual training, professional caring interaction training (according to the protocol designed by researchers based on relevant texts and research variables) will be provided to nurses Which include: definition of caring interaction, history about it, factors which influencing on  a caring interaction, the impact of each area of ​​the questionnaire on the caring interaction and vice versa, the impact of caring interaction on various aspects of treatment and disease and strategies for creating an appropriate caring interaction.</i_keyword>
      <i_keyword>Control group: After describing the purpose of the study and obtaining informed consent, in the first session, the researcher presented a questionnaire including demographic characteristics of patients and caring nurse-patient interaction scale (patient-version) to patients with at least 3 days hospitalization at cardiac care units and a questionnaire including demographic characteristics of nurses and the caring nurse-patient interaction scale( nurse-version) to cardiac care unit nurses. The questionnaires will be completed, and again one month later, These questionnaires will be distributed and collected by a bachelor of science in nursing who is working in that cardiac care unit. The nurses in the control group will receive only the usual training( routine training) , and training in The field of caring interactions will not be provided to this group. It should be noted that at the end of the intervention, the training provided to the intervention group will be provided to the nurses of the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Caring nurse-patient interaction. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Caring Nurse-Patient Interactions Scale: 23-item Version.</prim_outcome>
      <prim_outcome>Caring interaction education. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Caring Nurse-Patient Interactions Scale: 23-item Version.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-07</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Science</contact_name>
        <contact_address>No. 1, East Amirkabir, Kheirkhah dead end alley, Rafsanjan, Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
