<?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>IRCT20220728055572N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-04</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of implementing a thirst relief program on the thirst in intensive care unit patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of implementing a thirst relief program on the thirst in intensive care unit patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>82</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65304</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Closed envelopes: will be placed in closed envelopes after random allocation, and after selecting the research sample, it will come out of the envelope in the allocation package and the individual will be placed in the intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Thirst of patients hospitalized in the intensive care unit.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group of the thirst relief program will be implemented. The components of this program are that during one day, from 8:00 am to 8:00 pm, the thirst relief program will be implemented in such a way that at 8:00 am and also at 2:00 pm using the form (bedside oral health exam) Examination of the need for mouthwash and care and necessary measures will be implemented according to the patient's condition and related to thirst and oral hygiene (such as mouthwash) and then from 8:00 am to 8:00 pm every 2 hours, severity and distress Thirst will be evaluated using the Namrik criterion, and if it has a score of 3 or more, the thirst relief pack includes the use of a wet swab first, then cold water spray (below 4 degrees Celsius) and finally the use of menthol (0.1%) on the lips (that the whole intervention will last approximately 5 minutes will be implemented. Also, placing wet gauze on the patient's teeth will be used throughout the study for both control and intervention groups. Intervention 2: Control group: At 8:00 am and also at 2:00 pm using the form (Bedside oral exam, oral health examination will be performed to determine the need for mouthwash and the necessary care and care for the patient's condition and related to thirst and oral hygiene (such as mouthwash). and then from 8:00 am to 8:00 pm every 2 hours, the intensity and speed of thirst will be evaluated using the evaluation criteria, and if it has a score of 3 or more, it will be given to care and care will be taken, also from Placing gas in the labia of the patient's teeth will be used throughout the study for both control and intervention groups.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Hajiabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing &amp; Midwifery School. Ebnesina Ave., Daneshgah Blvd., mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>hajiabadif@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fatemeh Hajiabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, University of Mashhad, Khorasan Razavi</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>hajiabadif@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Proficiency in Persian language
Age between 18 and 65 years
Having a score of +1 - 1- from the Richmond Irritability-Sedation Scale
At least 24 hours of stay in the intensive care unit and 48 hours stay in the ward
Not having a history of mental problems according to family members
Absence of surgery and wounds in the mouth and lips (based on the oral health form (bedside oral exam)
no fluid intake by mouth</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue cooperation in conducting research at any stage
Changing the patient's state of consciousness so that she is unable to communicate.
The occurrence of severe respiratory or hemodynamic disorder so that the patient is unable to continue participating in the study.
Any obstacle that causes a delay in the intervention (conducting diagnostic tests outside the department, etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R68.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dry mouth, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group of the thirst relief program will be implemented. The components of this program are that during one day, from 8:00 am to 8:00 pm, the thirst relief program will be implemented in such a way that at 8:00 am and also at 2:00 pm using the form (bedside oral health exam) Examination of the need for mouthwash and care and necessary measures will be implemented according to the patient's condition and related to thirst and oral hygiene (such as mouthwash) and then from 8:00 am to 8:00 pm every 2 hours, severity and distress Thirst will be evaluated using the Namrik criterion, and if it has a score of 3 or more, the thirst relief pack includes the use of a wet swab first, then cold water spray (below 4 degrees Celsius) and finally the use of menthol (0.1%) on the lips (that the whole intervention will last approximately 5 minutes will be implemented. Also, placing wet gauze on the patient's teeth will be used throughout the study for both control and intervention groups.</i_keyword>
      <i_keyword>Control group: At 8:00 am and also at 2:00 pm using the form (Bedside oral exam, oral health examination will be performed to determine the need for mouthwash and the necessary care and care for the patient's condition and related to thirst and oral hygiene (such as mouthwash). and then from 8:00 am to 8:00 pm every 2 hours, the intensity and speed of thirst will be evaluated using the evaluation criteria, and if it has a score of 3 or more, it will be given to care and care will be taken, also from Placing gas in the labia of the patient's teeth will be used throughout the study for both control and intervention groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Thirst intensity score based on Namrik criteria. Timepoint: from 8 to 20 every two hours (8-10-12-14-16-18-20). Method of measurement: - Numerical scale (0-10) to measure the intensity of thirst.</prim_outcome>
      <prim_outcome>Thirst distress score obtained from the Thirst Distress Scale- Heart Failure. Timepoint: from 8 to 20 every two hours (8-10-12-14-16-18-20). Method of measurement: Using the Thirst Distress Scale-Heart Failure tool.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-11</approval_date>
        <contact_name>Research Ethics committee of  Mashhad University of Medical Sciences</contact_name>
        <contact_address>Nursing &amp; Midwifery School. Ebnesina Ave., Daneshgah Blvd., mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
