<?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>IRCT20220109053677N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-17</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of hot/cold water foot bath on the level of job fatigue and quality of life of health personnel of intensive health care units.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of hot/cold water foot bath on the level of job fatigue and quality of life of health personnel of intensive health care units.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61309</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Allocating people will be done by block randomization method. Block size 4 is considered. So we have six quadruple blocks consisting of AABB, ABAB, BBAA, BABA, ABBA, BAAB. The selection of each block will also be random and will be done using dice. For example, if the number 3 is rolled in a dice, the BBAA block is considered, so the first two patients are assigned to treatment B and the next two patients to treatment A. The dice will be thrown 13 times to complete the assignment of patients to treatment groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Job fatigue. Condition 2: satisfaction with quality of life.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: participants are recommended that one hour before bedtime or when they have at least 5 hours of continuous sleep, to put both feet, Below the knees, in a container containing hot or cold water, based on the season, and after 15 minutes dry feet. Water temperature must be, 40-42 C in cold seasons and 10-15 C in hot seasons. Intervention 2: Control group: The control group will not take any action during this period.</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:
Swedish Job Exhaustion Questionnaire and 12 Quality of Life Questionnaire

When:
Up to 3 months after completing the project to review and analyze the findings

To whom:
Executors

Conditions:
To announce the effect or not of using foot water to relieve fatigue in the staff of hard boats.

Where to obtain:
Executors

How to obtain:
Refer to Qom School of Traditional Medicine and the organizers of the project, namely Dr. Fatemeh Tuyserkani or Dr. Fatemeh Nojavan.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Tooiserkany</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 Khordad St., corner of 44th Alley, Faculty of Traditional Medicine</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713649373</zip>
        <telephone>+98 25 3776 4074</telephone>
        <email>dr.tooiserkany@gmail.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Tooiserkany</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 Khordad St., more than 44th Alley, Faculty of Traditional Medicine</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3713649373</zip>
        <telephone>+98 25 3776 4074</telephone>
        <email>dr.tooiserkany@gmail.com</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20-70 years
Informed consent to participate in the project 
Employment in the intensive care units of Qom hospitals.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of serious heart, liver, kidney, and skin diseases
Fever above 39 ° C
Pregnancy and lactation
Existence of wounds or lesions and active skin diseases in the legs and feet
The unwillingness of the person to participate in the project.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></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 group: participants are recommended that one hour before bedtime or when they have at least 5 hours of continuous sleep, to put both feet, Below the knees, in a container containing hot or cold water, based on the season, and after 15 minutes dry feet. Water temperature must be, 40-42 C in cold seasons and 10-15 C in hot seasons.</i_keyword>
      <i_keyword>Control group: The control group will not take any action during this period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Job fatigue. Timepoint: Upon entering the project, two weeks after entering the project (completion of the project). Method of measurement: Fill out the questionnaire.</prim_outcome>
      <prim_outcome>Satisfaction with quality of life. Timepoint: Upon entering the project, two weeks after entering the project (completion of the project). Method of measurement: Fill out the 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>Ghoum University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-21</approval_date>
        <contact_name>Ethics Committee of Qom University of Medical Sciences</contact_name>
        <contact_address>Coastal Street. Qom University of Medical Sciences Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
