<?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>IRCT20110425006284N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-31</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of foot reflexology on fatigue and anxiety.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology on fatigue and anxiety during post partum in primiparous.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30314</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Simple randomization, lottery.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: State anxiety. Condition 2: Trait anxiety. Condition 3: Fatigue.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After placing the patient in a proper position,firstly do heating techniques from the dominant person's feet.Then will be done massage from the dominant  foot  and at three points of the pituitary gland, the solar plexus and the spine. The Tonify technique  use to stimulate the pituitary point and to stimulate the solar plexus point and the spine will be used with the Basic grip technique.Duration of the intervention since the beginning of  massage for both feet 30 minutes( every foot 15 minutes) per day for each person it will take 3 consecutive days. Before intervention, after 3 consecutive sessions(ten minutes after the end of the intervention) and one week after the end of the intervention again the Spielberger test questionnaire and visual assessment of fatigue will be completed by the participants and educational pamphlets will be given. Intervention 2: Control group: control group will receive postpartum routine care. fatigue and anxiety with Spielberger  test questionnaire and visual assessment of fatigue will be measured. in the end, educational pamphlets will be given.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sekoufeh.Maleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing And Midwifery School , Nosrat St., District 6., Tehran., Tehran Province</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 217171669221</telephone>
        <email>malekishekoufeh@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Modares Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing And Midwifery School , Nosrat St., District 6., Tehran., Tehran Province</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4312</telephone>
        <email>modarres@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be primiparous
Natural vaginal delivery without tool must be done
The infant to be term and healthy, singleton
Exclusive breastfeeding
No chronic and acute disease (diabetes,blood pressure,depression)
The absence of unexpected incidents in the last 3 months for a first-degree relative according to the said referrer
Earn 40 or higher scores from the Fatigue Questionnaire and having mild and moderate levels of anxiety
Visit between day 10 and maximum 15 days after childbirth
With out varicose veins leg,Infection,pain or injury in the lower legs, ankles or feet</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness women to continuation of presence at research
Take special medication such as anti-anxiety drugs and sedatives and Sleeping
Unfollow the massage by mothers in the program for one session
Occurrence of any side effects during the intervention including tenderness of sensitive oil and  touch sensitive mothers</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F53</hc_code>
      <hc_code>F53</hc_code>
      <hc_code>F53</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Puerperal psychosis</hc_keyword>
      <hc_keyword>Puerperal psychosis</hc_keyword>
      <hc_keyword>Puerperal psychosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After placing the patient in a proper position,firstly do heating techniques from the dominant person's feet.Then will be done massage from the dominant  foot  and at three points of the pituitary gland, the solar plexus and the spine. The Tonify technique  use to stimulate the pituitary point and to stimulate the solar plexus point and the spine will be used with the Basic grip technique.Duration of the intervention since the beginning of  massage for both feet 30 minutes( every foot 15 minutes) per day for each person it will take 3 consecutive days. Before intervention, after 3 consecutive sessions(ten minutes after the end of the intervention) and one week after the end of the intervention again the Spielberger test questionnaire and visual assessment of fatigue will be completed by the participants and educational pamphlets will be given.</i_keyword>
      <i_keyword>Control group: control group will receive postpartum routine care. fatigue and anxiety with Spielberger  test questionnaire and visual assessment of fatigue will be measured. in the end, educational pamphlets will be given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>State anxiety. Timepoint: At the beginning of the study (before intervention)،After 3 consecutive sessions (ten minutes after the intervention) and one week after the end of the intervention. Method of measurement: Spielberger State-Trait Anxiety questionnaire.</prim_outcome>
      <prim_outcome>Trait anxiety. Timepoint: At the beginning of the study (before intervention)،After 3 consecutive sessions (ten minutes after the intervention) and one week after the end of the intervention. Method of measurement: Spielberger State-Trait Anxiety questionnaire.</prim_outcome>
      <prim_outcome>Fatigue. Timepoint: At the beginning of the study (before intervention)،After 3 consecutive sessions (ten minutes after the intervention) and one week after the end of the intervention. Method of measurement: Visual Fatigue Assessment 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-25</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences Faculty of Nursing and Midwifery and Rehab</contact_name>
        <contact_address>Nursing And Midwifery School , Nosrat St., District 6., Tehran., Tehran Province Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
