<?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>IRCT2017032733153N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-16</date_registration>
      <primary_sponsor>Vice chancellor for research,Birgand University of Medical Sciences</primary_sponsor>
      <public_title>The effect of comfort- based nursing cares on the perception of care behaviors and comfort</public_title>
      <acronym></acronym>
      <scientific_title>The effect of comfort- based nursing cares on their perception of nursing care behaviors and comfort level among patients undergoing open heart surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25652</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: allocate patients to permutation blocking manner to experimental and control groups.</study_design>
      <phase>2-3</phase>
      <hc_freetext>open heart surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Interventions include modification of environmental lights, devices’ alarm and personnel sounds and reflexothrapy in reflective chest point under the thumb of the left foot and cardiac surgery care training through face-to-face education and pamphlets. Interventions will be implemented during six consecutive days at 17 o’clock. Intervention 2: Control group will receive only routine care. Pamphlets will be given to patients on sixth day in order to comply with the ethical principles.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Sheikhy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Roshanna complex, Sina 9, Ebne Sina Street, Kordkoy, Golestan Province.</address>
        <city>Kordkoy</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+1 734326445</telephone>
        <email>ilia.sheikhy1364@gmail.com; Fa.sheikhy@bums.ac.ir</email>
        <affiliation>Birgand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahnaz Tabiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Birgand University Medical Sciences, Ayatollah Ghaffari Street;,Birgand, South Khorasan-</address>
        <city>Birgand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+56 32381410</telephone>
        <email>shahnaztabiee@bums.ac.ir</email>
        <affiliation>Birgand University Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: being at the age of 25 to 60 years; the willingness to participate in the study; signing an informed consent; complete consciousness of the patient; not being emergency surgery, the ability to make a verbal communication; the ability to read and write; there are no scratches, scars, corn, infection or any loss and damage in the feet; no history of mental illness or addiction and absence of vision or hearing impairments; PTT in the range of 30 to 60.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I97.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other functional disturbances following cardiac surgery</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: Interventions include modification of environmental lights, devices’ alarm and personnel sounds and reflexothrapy in reflective chest point under the thumb of the left foot and cardiac surgery care training through face-to-face education and pamphlets. Interventions will be implemented during six consecutive days at 17 o’clock.</i_keyword>
      <i_keyword>Control group will receive only routine care. Pamphlets will be given to patients on sixth day in order to comply with the ethical principles.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patients' perception of nursing care behaviors. Timepoint: 24 hour after surgery and before intervention and six days after intervention. Method of measurement: Caring Behavior Inventory Questionnaire.</prim_outcome>
      <prim_outcome>Comfort. Timepoint: 24 hour after surgery and before intervention and six days after intervention. Method of measurement: Hospice comfort questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Comfort Physical dimension. Timepoint: 24 houre after surgery and before the intervention and after the intervention in Six days. Method of measurement: score of Physical Dimension of comfort questionnaire.</sec_outcome>
      <sec_outcome>Comfort psycological dimension. Timepoint: 24 houre after surgery and before the intervention and after the intervention in Six days. Method of measurement: score of psycological Dimension of comfort questionnaire.</sec_outcome>
      <sec_outcome>Comfort environmental dimension. Timepoint: 24 hour after surgery and before the intervention and after the intervention on sixth day. Method of measurement: Score of environmental Dimension of comfort questionnaire.</sec_outcome>
      <sec_outcome>Comfort social dimension. Timepoint: 24 hour after surgery and before the intervention and after the intervention in Six days. Method of measurement: score of social Dimension of comfort questionnaire.</sec_outcome>
      <sec_outcome>Respect others dimension. Timepoint: 24 hour after surgery and before the intervention and after the intervention in Sixth day. Method of measurement: score of Respect others dimension.</sec_outcome>
      <sec_outcome>Assurance of human presence Dimension. Timepoint: 24 hour after surgery and before the intervention and after the intervention in Six days. Method of measurement: Assurance of human presence Dimension score.</sec_outcome>
      <sec_outcome>Positive Communication and attitude Dimension. Timepoint: 24 hour after surgery and before the intervention and after the intervention on Sixth days. Method of measurement: Positive Communication and attitude Dimension score.</sec_outcome>
      <sec_outcome>Knowledge and Professional skills dimension. Timepoint: 24 houre after surgery and before the intervention and after the intervention in Six days. Method of measurement: Knowledge and Professional skills dimension score.</sec_outcome>
      <sec_outcome>Attention to others' experiences dimension. Timepoint: 24 hour after surgery and before the intervention and after the intervention on sixth day. Method of measurement: Attention to others' experiences dimension score.</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>Vice chancellor for research,Birgand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-02</approval_date>
        <contact_name>Ethics committee of Birgand University of Medical Sciences</contact_name>
        <contact_address>Birgand University of Medical Sciences; Ayatollah Ghaffari street; Birjand; South Khorasan Birgand  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
