<?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>IRCT20161227031588N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-06</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>effect of lifestyle-based combined intervention on sleep quality and occupational fatigue of nurses</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of lifestyle-based combined intervention program on sleep quality and occupational fatigue of female nurses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65091</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to determine the samples, a random method will be used. For randomization, the names of the people will be put into a pot, then the first one will be randomly placed in the intervention group and the second one will be placed in the control group, and this will continue until there are 60 people. In this way, the names of the nurses in Taleghani Hospital and similar departments in Imam Khomeini Hospital will be listed, and 30 people will be considered for the intervention group and 30 people will be considered for the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Sleep Quality. Condition 2: Occupational Fatigue.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 1) teaching the principles of sleep hygiene (using a diet containing tryptophan, not consuming caffeine-containing foods before sleep, having enough physical activity and rest during the day and sleeping between 7 and 8 hours at night) to the intervention group. The training will include a virtual meeting with Skyroom and the file of this content will also be placed on the WhatsApp channel. The daily observance of these principles will be followed up through a self-reporting checklist completed by each person.2) Training of progressive muscle relaxation technique by Jacobson method, which training will be done by sending an audio file and educational content to the WhatsApp channel, and the daily performance of this technique will be followed for two months through a self-reporting checklist completed by each person.3) Sending aerobic exercises prepared by the coach of the sports federation. The prepared exercises will be sent to the WhatsApp channel of the intervention group, which will be carried out 5 days a week for two months by the members of the intervention group. Intervention 2: Control group: no intervention will be done. At first, the questionnaires of Swedish occupational fatigue and sleep quality of Pittsburgh will be filled by the members of the control group, and after two months these questionnaires will be completed again by these people.</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:
Individual data of participants can be shared after de-identification.

When:
Three months after the results are published

To whom:
Researchers working in academic and scientific centers

Conditions:
The use of documentation in research

Where to obtain:
by Email:  z.farzane.8223@gmail.com

How to obtain:
by Email:  z.farzane.8223@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Haleh Ghavami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pardis Nazlou, 11 km of Nazlou Road, Urmia, Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714985454</zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>haleh_ghavami@yahoo.co.uk</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haleh Ghavami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pardis Nazlou, 11 Km of Nazlou Road, Urmia, Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714985454</zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>haleh_ghavami@yahoo.co.uk</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age range from 22 to 45
not having any physical or mental illness or any condition that causes fatigue such as anemia, kidney failure and multiple sclerosis in the past 6 months
having a bachelor's degree in nursing
not taking special drugs that affect fatigue
rotating shift
no pregnancy
no breastfeeding
not having thyroid diseases during the study</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y98</hc_code>
      <hc_code>Z73.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lifestyle-related condition</hc_keyword>
      <hc_keyword>Social role conflict, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 1) teaching the principles of sleep hygiene (using a diet containing tryptophan, not consuming caffeine-containing foods before sleep, having enough physical activity and rest during the day and sleeping between 7 and 8 hours at night) to the intervention group. The training will include a virtual meeting with Skyroom and the file of this content will also be placed on the WhatsApp channel. The daily observance of these principles will be followed up through a self-reporting checklist completed by each person.2) Training of progressive muscle relaxation technique by Jacobson method, which training will be done by sending an audio file and educational content to the WhatsApp channel, and the daily performance of this technique will be followed for two months through a self-reporting checklist completed by each person.3) Sending aerobic exercises prepared by the coach of the sports federation. The prepared exercises will be sent to the WhatsApp channel of the intervention group, which will be carried out 5 days a week for two months by the members of the intervention group.</i_keyword>
      <i_keyword>Control group: no intervention will be done. At first, the questionnaires of Swedish occupational fatigue and sleep quality of Pittsburgh will be filled by the members of the control group, and after two months these questionnaires will be completed again by these people.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality. Timepoint: Before and after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</prim_outcome>
      <prim_outcome>Occupational fatigue. Timepoint: Before and after the intervention. Method of measurement: Swedish Occupational Fatigue Inventory.</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>Urmia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-25</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Orjhans Street, Resalat Blvd, Urmia Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
