<?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>IRCT20180911041006N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-22</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the foot reflexology on the pain and fatigue of nurses.</public_title>
      <acronym></acronym>
      <scientific_title>The study of the effect of foot reflexology on the shoulder, neck and waist pains as well as refreshment of the nurses.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33825</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Skeletal and muscular pain and fatigue.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the intervention group, according to the location of pain, a 9-sessions foot reflexology protocol have been applied on the test group by the contributing researcher (after passing the training and acquiring skills) under supervision of the physiotherapist  (for 3 weeks and 3 sessions per 30 minutes each week). The reflexology process will be such that the study unit is asked to lie on the examination bed in a quiet and bright room, close its eyes and place in a completely relaxed position. Then, after mild foot massage, the heel of the left foot would be kept pressed and bend it to the right and directly pressed (the point affecting the fatigue) with a thumb on the solar grid (Solar Plexus). Then, the massager get the patient's leg with One hand and by use of thumb of another hand, apply pressure on the reflex points of the waist, spine, ankle or any organ that is based on the Nordic questionnaire for the pain. By the individual, the alternating wave forms and smokes come in and out. This will be done within 30 minutes for both legs. Then they were asked to use fluids for 24-48 hours after each session. It should be noted that the reflexology of the female nurses is carried out by the implementer and under the supervision of a specialist physiotherapist for the protection of the Islamic components by a collaborator and in a closed environment, and reflexology of the men. control group:. Intervention 2: Control group:  In the control group, no intervention will be performed and they will  only with the experimental group before and after the intervention, the Nordic and VAS questionnaires and the checklist of.</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:
ِdata of Pain intensity and fatigue severity

When:
Summer of 1398

To whom:
only researchers

Conditions:
Researchers after obtaining permission from the research team

Where to obtain:
Hojatollah Mirzaeenia

How to obtain:
Accept permission by email and related explanations regarding how to use the data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hojat Alah Mirzaeenia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kianpars St , 1 st square , next to the fire department , Ashoori Alley , No . 81</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6133645641</zip>
        <telephone>+98 61 3336 2889</telephone>
        <email>mirzaeenia.h@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hojat Alah Mirzaeenia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kianpars St , 1 st square , next to the fire department , Ashoori Alley , No . 81</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6133645641</zip>
        <telephone>+98 61 3336 2889</telephone>
        <email>mirzaeenia.h@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>BMI should be between 18 and 25.
Should not be athlete.
Age range should be between 20 to 50 years.
The nursing staff suffering from backache as well as shoulder and neck pain.
Nursing staff with fatigue.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a foot ulcer.
Having peripheral neuropathy.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the musculoskeletal system and connective tissue</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the intervention group, according to the location of pain, a 9-sessions foot reflexology protocol have been applied on the test group by the contributing researcher (after passing the training and acquiring skills) under supervision of the physiotherapist  (for 3 weeks and 3 sessions per 30 minutes each week). The reflexology process will be such that the study unit is asked to lie on the examination bed in a quiet and bright room, close its eyes and place in a completely relaxed position. Then, after mild foot massage, the heel of the left foot would be kept pressed and bend it to the right and directly pressed (the point affecting the fatigue) with a thumb on the solar grid (Solar Plexus). Then, the massager get the patient's leg with One hand and by use of thumb of another hand, apply pressure on the reflex points of the waist, spine, ankle or any organ that is based on the Nordic questionnaire for the pain. By the individual, the alternating wave forms and smokes come in and out. This will be done within 30 minutes for both legs. Then they were asked to use fluids for 24-48 hours after each session. It should be noted that the reflexology of the female nurses is carried out by the implementer and under the supervision of a specialist physiotherapist for the protection of the Islamic components by a collaborator and in a closed environment, and reflexology of the men. control group:</i_keyword>
      <i_keyword>Control group:  In the control group, no intervention will be performed and they will  only with the experimental group before and after the intervention, the Nordic and VAS questionnaires and the checklist of</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The backache intensity. Timepoint: Before the intervention and ten days after that. Method of measurement: The visual analogue scale.</prim_outcome>
      <prim_outcome>The fatigue intensity. Timepoint: Before the intervention and ten days after that. Method of measurement: Fatigue questionnaire sofi -20.</prim_outcome>
      <prim_outcome>The neck pain intensity. Timepoint: Before the intervention and ten days after that. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>The shoulder pain intensity. Timepoint: Before the intervention and ten days after that. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality  of life. Timepoint: Before the intervention and one month after the end of the intervention. Method of measurement: SF-36 Questionnaire.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-08</approval_date>
        <contact_name>Ethics Committee of Ahwaz  University of Medical Sciences</contact_name>
        <contact_address>Room 4 ,Ground Floor , deputy of Research and Technology Dvelopment of ahwaz Jundishapur University of Medical Sciences , University of Ahwaz Ahwaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
