<?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>IRCT20180509039592N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-06</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of massage with or without aromatic substance on the incidence of delirium in patient undergoing heart surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of massage with or without aromatic substance on the incidence of delirium in patient undergoing heart surgery in Afshar Hospital, Yazd, in 2017</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31057</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: Patients who have inclusion criteria are included in the study using available sampling method and then divided into two intervention and control groups using stratified random allocation method. The samples will be placed in two groups according to gender, age (2 ±), and type of disease. In other words, the first one randomly (using a lottery) is placed in one of the two groups of intervention or control group and the subsequent samples are allocated to each of the groups according to the matching variables and observing random conditions, Blinding description: The therapeutic effect of the intervention has been obscured by participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Delirium  after heart surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Massage group with aromatic substance: In this group, samples are received in addition to receiving routine care, massage with scented face and face twice a day (morning and night) until the patient is admitted to the intensive care unit. (Patients are often admitted to the heart care unit for 3 to 4 days). The first massage is the day after the heart surgery, provided that the patient is extubated. The essence of the scent is the Rose Essence. In this study, the essential oil of Rose (produced by Barij Essen, Kashan) is used in the base of sweet almond oil at a concentration of 4%. For each massage, 2 cc of scented oil is used. Prior to initiating the first massage and after massage by another trained person, the incidence and severity of delirium by using the NeeCham questionnaire at the end of each day until the patient is admitted to the intensive care unit and assessed prior to discharge from the caregiver department. Intervention 2: Intervention group: Massage without aromatic substant: In this group, in addition to receiving routine care, massage with 2 cc sweet peas and almond oil for 15 minutes on the day after the procedure twice a day (morning and night) As long as they are admitted to the intensive care unit. Prior to initiating the first massage and after massage by another trained person, the incidence and severity of delirium by using the NeeCham questionnaire at the end of each day until the patient is admitted to the intensive care unit and assessed prior to discharge from the caregiver department. Intervention 3: Control group: In the control group only routine care is provided in the heart care unit. In this section, if the illness affects delirium, a psychiatric consultation is requested by the surgeon of the heart and after the visit by the psychiatrist, the medication orders are administered, and the patient's family is asked to come to the patient's appointment in each shift. Connect with him. At the end of each day, until the patient is admitted to the intensive care unit, she is evaluated prior to discharge from the caregiver department.</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:
Potential data can be shared after unidentifiable individuals

When:
Start the month access period after printing the results

To whom:
Researchers working in academia and academia

Conditions:
The data is sent through an official request and by e-mail

Where to obtain:
f_askarkafi@kmu.ac.ir

How to obtain:
The data is sent through an official request and by e-mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Askarkafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of the axis ofhaft bagh alavi, Kerman University of Medical Sciences</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>f_askarkafi@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>farzaneh askarkafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of the axis of haft bagh alavi, Kerman University of Medical Sciences</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>f_askarkafi@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing cardiac surgery for the first time
Age between 18 and 75 years
Patients who have a positive olfactory test
Patients who have tested negative for their sensitivity
Patients who do not mention any history of skin sensitivity
Patients who do not mention any history of mental illness or psychiatric use, with the exception of chlordiaspoxide and oxazepam</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If the patient undergoes surgical complications, he or she will be transferred to the operating room.
If the patient does not remove the mechanical ventilation until the day after surgery (do not extube)
In the event of unwanted and unpredictable effects</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Massage group with aromatic substance: In this group, samples are received in addition to receiving routine care, massage with scented face and face twice a day (morning and night) until the patient is admitted to the intensive care unit. (Patients are often admitted to the heart care unit for 3 to 4 days). The first massage is the day after the heart surgery, provided that the patient is extubated. The essence of the scent is the Rose Essence. In this study, the essential oil of Rose (produced by Barij Essen, Kashan) is used in the base of sweet almond oil at a concentration of 4%. For each massage, 2 cc of scented oil is used. Prior to initiating the first massage and after massage by another trained person, the incidence and severity of delirium by using the NeeCham questionnaire at the end of each day until the patient is admitted to the intensive care unit and assessed prior to discharge from the caregiver department.</i_keyword>
      <i_keyword>Intervention group: Massage without aromatic substant: In this group, in addition to receiving routine care, massage with 2 cc sweet peas and almond oil for 15 minutes on the day after the procedure twice a day (morning and night) As long as they are admitted to the intensive care unit. Prior to initiating the first massage and after massage by another trained person, the incidence and severity of delirium by using the NeeCham questionnaire at the end of each day until the patient is admitted to the intensive care unit and assessed prior to discharge from the caregiver department.</i_keyword>
      <i_keyword>Control group: In the control group only routine care is provided in the heart care unit. In this section, if the illness affects delirium, a psychiatric consultation is requested by the surgeon of the heart and after the visit by the psychiatrist, the medication orders are administered, and the patient's family is asked to come to the patient's appointment in each shift. Connect with him. At the end of each day, until the patient is admitted to the intensive care unit, she is evaluated prior to discharge from the caregiver department</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Delirium: In Delirium DSM-5, Delirium is defined as a distraction of attention and concentration, which usually has a sudden onset, accompanied by disturbance in navigation, short-term memory impairment, change in sensory perception (illusion), abnormal thinking process, and turbulent behavior. Timepoint: Before the intervention, at the end of each day, until the patient is admitted to the ICU. Method of measurement: NEECHAM delirium measurement 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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-04</approval_date>
        <contact_name>Ethics Committee in Kerman University of Medical Sciences</contact_name>
        <contact_address>Four Way Somayeh (Tahmasebabad), Beginning of Jihad Boulevard, Beginning of Ibn Sina St kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
