<?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>IRCT20181111041608N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-20</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Determining the effect of foot reflexology massage on pain and fatigue after lumbar spine surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology massage on pain and fatigue after lumbar spine surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35182</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: no, Randomization description: After easy sampling of qualified individuals and completion of informed written consent, samples are divided into two groups of test and control according to the list drawn from the random numbers table, Blinding description: Patients were divided into two groups of test and control. They were explained to the patients themselves (both groups). Data was collected at all stages by an unknowing nurse of the group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Spinal Surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, the researcher thoroughly washes his hands with warm water and smears with olive oil and massage together to slip through the warmth of the hands to ease the reflex massage. The patient is placed in the back rest position and, while foot massage, is supported by a pillow below it, and placed higher and removed after the massage of the pillow. After relaxing techniques for 5 minutes, the pituitary reflexes, Solar Plexus points, the spinal reflex points are massage for 10 minutes. The total massage time is 30 minutes (15 minutes each). Intervention 2: Control group: In the control group, the researcher at the time corresponding to the test group, twice in 5 minutes intervals, and at least once for a minute, without any compression, lubricates the points on both sides of the patient.</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 results are published

When:
Three months after completion

To whom:
For scholars working in academia and academia

Conditions:
by Email

Where to obtain:
With the author of the article

How to obtain:
رIt is answered by e-mail as soon as possible

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Amirpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasuj Shahid Motahari</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591794857</zip>
        <telephone>+98 74 3322 4721</telephone>
        <email>m.amirpoor@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mostafa Javadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd - Safaiyeh - Bou-Ali Boulevard - Nursing and midwifery department</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8915173160</zip>
        <telephone>+98 35 1824 1751</telephone>
        <email>javadi@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. At least 3 months of back pain before surgery2. Be alert at the time of research3. Age between 35 and 60 years4. Spinal cord stenosis in the lumbar region with moderate severity5. Body Mass Index (BMI) Between 5/16 to 30</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. No tolerance 2. Anesthesia in the legs 3. Vascular disorders of the lower limbs 4. Lower limb flexion 5. Drug Addiction and Substance Abuse 6. Get Pain Pump By Self Patient 7. Rupture of Intervertebral Disk 8. Stroke of Spinal Cord</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G55.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>G55.1</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: First, the researcher thoroughly washes his hands with warm water and smears with olive oil and massage together to slip through the warmth of the hands to ease the reflex massage. The patient is placed in the back rest position and, while foot massage, is supported by a pillow below it, and placed higher and removed after the massage of the pillow. After relaxing techniques for 5 minutes, the pituitary reflexes, Solar Plexus points, the spinal reflex points are massage for 10 minutes. The total massage time is 30 minutes (15 minutes each).</i_keyword>
      <i_keyword>Control group: In the control group, the researcher at the time corresponding to the test group, twice in 5 minutes intervals, and at least once for a minute, without any compression, lubricates the points on both sides of the patient.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PAIN. Timepoint: Post-interventional pain (30 minutes for control group), 60 minutes after intervention, 90 minutes after intervention, 24 hours after intervention. Method of measurement: Standard Scale -New.</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: Post-interventional pain (30 minutes for control group), 60 minutes after intervention, 90 minutes after intervention, 24 hours after intervention. Method of measurement: Standard Scale -New.</prim_outcome>
      <prim_outcome>Signs of blood pressure and respiratory and pulse. Timepoint: Post-interventional pain (30 minutes for control group), 60 minutes after intervention, 90 minutes after intervention, 24 hours after intervention. Method of measurement: Pulse measurements are measured by touching the pulse position and the counting and inhalation by measuring and observing the pressure measurement device.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-06</approval_date>
        <contact_name>Ethics Committee in Shahid Sadoughi University of Medical Sciences Yazd</contact_name>
        <contact_address>Yasuj shahid motahari Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
