<?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>IRCT20100211003329N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-04</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of ear acupressure (Auriculotherapy) on cognitive failure in nurses</public_title>
      <acronym></acronym>
      <scientific_title>The effect of ear acupressure (Auriculotherapy) on cognitive failure in nurses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66024</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: the eligible samples will be placed in the list in the order of review and then will be allocated to each of the two intervention and control groups by block randomization in the form of blocks of 4 and 8. Using Sealed Envelope Ltd software. 2017 available through the website www.sealedenvelope.com 4 blocks of 4 and 5 blocks of 8, a total of 9 blocks were defined, which will be assigned to groups based on the order specified by the mentioned tool, Blinding description: The participants are unaware of the nature of the seeds attached to their ears.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cognitive failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, researcher seed vaccaria Mark ZHONG YANG, made in China, will stick the 7 points related to cognitive function, including: Shen Men, zero point, hippocampus, main brain point, brain and memory 1 and 2 and to the unit The research (nurse) will be taught to press the points using the thumb and forefinger for six weeks, five days a week and three times a day, and each time each point for one minute. It should be noted that during the 6 weeks of the intervention, Vaccaria seeds will be stuck by the researcher alternately on both ears every week, after cleaning the skin with alcohol cotton. seeds will be placed on the ear five days a week and the patient will be asked to remove the adhesives at the end of the fifth day to prevent possible allergic reaction. The patient will be instructed to contact the researcher in case the adhesives are separated during the five-day period so that the researcher will re-attach the adhesives in the agreed place. During the intervention, a daily note sheet will be provided to the nurse every week, in which the number of times of pressure and the duration of pressure to all points each time, the occurrence of allergic reactions and the start of new medication will be determined. During the intervention period, every week all the participants will be visited at the agreed place and new stickers will be attached to them, and a daily note sheet will be given to them and another sheet will be given to them for the next week. If in the intervention group, the average duration of pressure on all points during each week of the intervention is less than 14 minutes per day, that person will be excluded from the study. Sticking the seeds will continue for 6 weeks and the samples will be followed up 4 weeks after the end of the intervention. Occupational cognitive impairment questionnaire will be completed by the samples at the beginning of the study, after the end of the intervention and 4 weeks after the end of the intervention. At the time of sampling, the workplace address and phone number of the samples were recorded, and during the intervention period, at the end of each week, also in order to follow up 4 weeks after the end of the intervention, by phone regarding the time and place of the visit and if necessary Transportation will be coordinated with him. Intervention 2: Control group: In the control group, adhesives will be applied to the points of shen men, zero point, hippocampus, main brain point, brain and memory 1 and 2, but without seeds and no pressure will be applied on them. It should be noted that during the 6 weeks of the intervention, in the control group, non-seeds adhesives will be applied alternately on both ears by the researcher every week after cleaning the skin with alcohol cotton. Seeds will be placed on the ear five days a week and the patient will be asked to remove the adhesives at the end of the fifth day to prevent possible allergic reaction. The patient will be instructed to contact the researcher in case the adhesives are separated during the five-day period so that the researcher will re-attach the adhesives in the agreed place.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Not done yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Tagharrobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb Ravandi Blvd, Kashan</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715981151</zip>
        <telephone>+98 31 5510 3119</telephone>
        <email>tagharrobi_z@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zahra Tagharrobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb Ravandi Blvd, Kashan</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715981151</zip>
        <telephone>+98 31 5510 3119</telephone>
        <email>tagharrobi_z@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Working in inpatient departments (direct patient care)
Having a work experience of at least 2 years at the bedside
Consent to participate in the study
Having a university degree in nursing
Moderate to high cognitive failure (getting a score of 40 or higher on the Occupational Cognitive Status Questionnaire)
The health of an organ in the area of the earlobe</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of access to samples during the study (emigration, death, etc.)
Hospitalization
Acute and severe stress (death of loved ones, divorce,...) during the study
Allergy to glue (sensitivity, redness, etc.) or any intolerance
Non-observance of the intended criterion in relation to the daily average duration of pressure to all points in each week of the intervention
Simultaneous use of other non-pharmacological methods
Treatment
Serious and acute physical or mental illness during the study
using acupressure or acupuncture during the last three months
using cigarettes, drugs and alcohol according to the person's own statement
pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G31.84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild cognitive impairment, so stated</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, researcher seed vaccaria Mark ZHONG YANG, made in China, will stick the 7 points related to cognitive function, including: Shen Men, zero point, hippocampus, main brain point, brain and memory 1 and 2 and to the unit The research (nurse) will be taught to press the points using the thumb and forefinger for six weeks, five days a week and three times a day, and each time each point for one minute. It should be noted that during the 6 weeks of the intervention, Vaccaria seeds will be stuck by the researcher alternately on both ears every week, after cleaning the skin with alcohol cotton. seeds will be placed on the ear five days a week and the patient will be asked to remove the adhesives at the end of the fifth day to prevent possible allergic reaction. The patient will be instructed to contact the researcher in case the adhesives are separated during the five-day period so that the researcher will re-attach the adhesives in the agreed place. During the intervention, a daily note sheet will be provided to the nurse every week, in which the number of times of pressure and the duration of pressure to all points each time, the occurrence of allergic reactions and the start of new medication will be determined. During the intervention period, every week all the participants will be visited at the agreed place and new stickers will be attached to them, and a daily note sheet will be given to them and another sheet will be given to them for the next week. If in the intervention group, the average duration of pressure on all points during each week of the intervention is less than 14 minutes per day, that person will be excluded from the study. Sticking the seeds will continue for 6 weeks and the samples will be followed up 4 weeks after the end of the intervention. Occupational cognitive impairment questionnaire will be completed by the samples at the beginning of the study, after the end of the intervention and 4 weeks after the end of the intervention. At the time of sampling, the workplace address and phone number of the samples were recorded, and during the intervention period, at the end of each week, also in order to follow up 4 weeks after the end of the intervention, by phone regarding the time and place of the visit and if necessary Transportation will be coordinated with him.</i_keyword>
      <i_keyword>Control group: In the control group, adhesives will be applied to the points of shen men, zero point, hippocampus, main brain point, brain and memory 1 and 2, but without seeds and no pressure will be applied on them. It should be noted that during the 6 weeks of the intervention, in the control group, non-seeds adhesives will be applied alternately on both ears by the researcher every week after cleaning the skin with alcohol cotton. Seeds will be placed on the ear five days a week and the patient will be asked to remove the adhesives at the end of the fifth day to prevent possible allergic reaction. The patient will be instructed to contact the researcher in case the adhesives are separated during the five-day period so that the researcher will re-attach the adhesives in the agreed place.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive failure score. Timepoint: Before the intervention, 6 weeks after the start of the intervention and 4 weeks after the end of the intervention. Method of measurement: The 30-question form of occupational cognitive failure questionnaire (OCFQ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Allergy to seed. Timepoint: weekly. Method of measurement: Diary sheet.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-23</approval_date>
        <contact_name>Research Ethics Committees of Faculty of Medicine &amp; Faculty of Dentistry- Kashan University of Medic</contact_name>
        <contact_address>Kashan University of Medical Sciences, Pezeshk Blvd, Qutb Rawandi Blvd, Kashan kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
