<?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>IRCT20210523051370N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-23</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of using  eye masks and earplugs on the onset of postoperative confusion</public_title>
      <acronym></acronym>
      <scientific_title>The effects of earplugs and eye masks during the night on the onset of delirium and sleep quality in patients undergoing coronary artery bypass grafting</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57182</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The experimental group will receive earplugs and eye masks And the control group receive only routine care. The intervention is performed simultaneously with the use of eye masks and earplugs in the cardiac intensive care unit for three consecutive nights (from the second night of admission) from 21-22 to 6-7 am by the caring nurse for the experimental group. Press and twist the earplugs into a spiral and thin, and then by pulling the top of the ear up and back, smooth the ear canal and press the sponge into the ear canal and hold 20-30 until the sponge expands in the ear canal. And after 10 minutes, check if the eye masks and earplugs are in place. If necessary, the patient's eye masks  and earplug can be removed and reused to communicate with the patient and perform medical and nursing care. The earplugs is disposable, but the eye masks can be used for three nights of intervention, Randomization description: Patients will be recruited using convenience sampling method and then will be randomly assigned to the experimental (group A) and control (group B) groups using block method (19 blocks) of length 6. The blocks will be numbered and sealed in 19 sequentially numbered opaque envelopes in random order (by someone outside the research team and unaware of the research objectives). 
The envelopes will be opened individually and the patients will be assigned to the relevant groups. The Random Allocation Software 2.0 will be used to generate randomization sequences, Blinding description: the Assessor and Statistician will be blind to Randomization.</study_design>
      <phase>N/A</phase>
      <hc_freetext>delirium and sleep quality.</hc_freetext>
      <i_freetext>Intervention 1: The intervention is performed by using eye masks and earplugs from the second night after coronary artery bypass graft surgery for three consecutive nights (from the second night of admission) from 21-22 to 6-7 in the morning by the Caring nurse for the experimental group. paksaman eye masks (Model 504, made in Iran) made of a thin layer of foam covered by a layer of anti-allergy fabric and placed with a soft and light elastic around the head And the classic 3M sponge earplug with 33 dB sound reduction capability will be used.Press the earplug into a spiral and thin, and then by pulling the top of the ear up and back, smooth the ear canal and press the sponge into the ear canal and hold 20-30 until the sponge expands in the ear canal. And after 10 minutes, check if the blindfold eareplug and earmuffs are in place.If necessary, the patient's eye masks and earplug can be removed and reused to communicate with the patient and perform medical and nursing care. The eye mask is disposable, but the blindfold can be used for three nights of intervention. Intervention 2: The control group also receives only routine ward care without any intervention.</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 All data will be kept confidential.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Seyed Afshin Shorofi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam square, Three-way Joibar, Mazandaran University of Medical Sciences</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815733971</zip>
        <telephone>+98 11 3336 7342</telephone>
        <email>ashorofi@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Seyed Afshin Shorofi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam square, Three-way Joibar, Mazandaran University of Medical Sciences</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815733971</zip>
        <telephone>+98 11 3336 7342</telephone>
        <email>ashorofi@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged ≥18 years
People who have undergone coronary artery bypass graft surgery
orientation to time, place and person
absence of hearing, speech and vision impairment
No previous cognitive pathology (including dementia, stroke, traumatic brain injury, encephalopathy, drug and alcohol abuse)
no need for intubation more than 24 hours</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Delirium at the time of entry criteria based on the Neecham scale</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delirium due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention is performed by using eye masks and earplugs from the second night after coronary artery bypass graft surgery for three consecutive nights (from the second night of admission) from 21-22 to 6-7 in the morning by the Caring nurse for the experimental group. paksaman eye masks (Model 504, made in Iran) made of a thin layer of foam covered by a layer of anti-allergy fabric and placed with a soft and light elastic around the head And the classic 3M sponge earplug with 33 dB sound reduction capability will be used.Press the earplug into a spiral and thin, and then by pulling the top of the ear up and back, smooth the ear canal and press the sponge into the ear canal and hold 20-30 until the sponge expands in the ear canal. And after 10 minutes, check if the blindfold eareplug and earmuffs are in place.If necessary, the patient's eye masks and earplug can be removed and reused to communicate with the patient and perform medical and nursing care. The eye mask is disposable, but the blindfold can be used for three nights of intervention.</i_keyword>
      <i_keyword>The control group also receives only routine ward care without any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Delirium severity and sleep quality. Timepoint: Baseline (before intervention: T0); Follow-ups For three consecutive nights (from the second night of admission). Method of measurement: Two Neelon-Champagne Confusion Scale and Verran and Snyder-Halpern Sleep Scale  to evaluate delirium severity and sleep quality.</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>IR.MAZUMS.REC.1400.303</sec_id>
        <issuing_authority>کمیته تخصصی اخلاق در پژوهش های زیست پزشکی</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-22</approval_date>
        <contact_name>Bioethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Moalem Square, Sari, Mazandaran Province sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
