<?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>IRCT20171203037723N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-29</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the Effect of Simple Massage and Foot Reflexology Massage on Fatigue and Impacts of Fatigue</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effect of Simple Massage and Foot Reflexology Massage on Fatigue and Impacts of  Fatigue among Female Nurses.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69676</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples will be selected based on the available sampling and inclusion criteria and. then they will be randomly divided into intervention and control groups. The samples will be allocated with stratified block randomization. Blocks will be matched according the age. For this purpose, 15 blocks of four will be considered. Block type selection will be done through random allocation 2 software. Code A means intervention group and code B means control group. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. As each patient enters, the envelopes will be opened and the treatment will be applied.</study_design>
      <phase>N/A</phase>
      <hc_freetext>fatigue.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Each of the nurses will be placed in the rest room and after washing and drying their feet, they will lie on the examination bed and the sole reflex massage protocol will be applied. The researcher will hold the foot with one hand. And by pressing on the sole of the foot, bend and straighten it from the wrist, then apply direct pressure on the three points of the pituitary gland, kidney and solar plexus with the thumb and it is done in a circular manner with the applied pressure. Each point will be 3 minutes, 9 + 1 sets equal to 10 minutes for each leg, a total of 20 minutes for two legs reflex massage. Intervention 2: Control group: Each of the nurses will be placed in the rest room and after washing and drying the feet, they will lie on the examination bed and a simple massage protocol without stimulating reflex points will be applied. The researcher will use the soles and fingers. The thumb is done by applying short pressure in a circular manner, starting from the heel to the fingers.</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 ----</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamideh Azimi Lolaty</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery, Vesal-e-Shirazi Ave, Amir Mazandarani Blvd</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815733971</zip>
        <telephone>+98 11 3336 7343</telephone>
        <email>azimihamideh@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamideh Azimi Lolaty</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery, Vesal-e-Shirazi Ave, Amir Mazandarani Blvd</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4815733971</zip>
        <telephone>+98 11 3336 7343</telephone>
        <email>azimihamideh@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study.
Being female.
Nurse`s fatigue at least 22 according to the Chalder Fatigue Scale.
At least one year has passed since the Working in one of the hospital departments.
Not having a second job, either working in another hospital or working in a profession other than nursing
Not recieving any other massage therapy plan.
Not drinking tea or coffee one hour before massage.
Not suffering from a chronic, debilitating or incurable disease such as Cancer, Hypertension and Diabet.
Not suffering from neurological and mental disease and getting score of less than 3.5 based on general public health scale.
Not suffering from severe neuropathy such as lumbar disc and multiple sclerosis(MS) .
Not having any kind of sores or blisters on the feet.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance to participate in the study.
Suffering from cancer, diabetes or hypertension.
Suffering from neurological or mental disease.
Suffering from severe neuropathy such as lumbar disc or multiple sclerosis(MS).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R53</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malaise and fatigue</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Each of the nurses will be placed in the rest room and after washing and drying their feet, they will lie on the examination bed and the sole reflex massage protocol will be applied. The researcher will hold the foot with one hand. And by pressing on the sole of the foot, bend and straighten it from the wrist, then apply direct pressure on the three points of the pituitary gland, kidney and solar plexus with the thumb and it is done in a circular manner with the applied pressure. Each point will be 3 minutes, 9 + 1 sets equal to 10 minutes for each leg, a total of 20 minutes for two legs reflex massage.</i_keyword>
      <i_keyword>Control group: Each of the nurses will be placed in the rest room and after washing and drying the feet, they will lie on the examination bed and a simple massage protocol without stimulating reflex points will be applied. The researcher will use the soles and fingers. The thumb is done by applying short pressure in a circular manner, starting from the heel to the fingers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue score in Chalder questionnaire. Timepoint: Before and immediatly after intervention. Method of measurement: Chalder Fatigue Scale.</prim_outcome>
      <prim_outcome>Fatigue effects score in Fisk questionnaire. Timepoint: Before and immediatly after intervention. Method of measurement: Fisk Fatigue Impact Scale.</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>Mazandaran University of Medical Siences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-10</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Student Research Department, Moallem St., Sari Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
