<?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>IRCT201203229322N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-06-30</date_registration>
      <primary_sponsor>Vice chancellor for research Tehran University of Medical Sciences</primary_sponsor>
      <public_title>the effect of foot reflexology massage on fatigue and anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of foot reflexology on fatigue and anxiety after cesarean section in mothers with hospitalized preterm neonate in Neonatal Intensive Care Unit(NICU)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>99</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9885</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: fatigue. Condition 2: anxiety.</hc_freetext>
      <i_freetext>Intervention 1: "Foot reflexology massage" or "reflexology" iwill be done for the intervention group which include three stages: preparation, heating with a 15-step techniques and massage techniques on reflex points of the pituitary, spinal cord  and solar plexus .reflection of the pituitary is in inner edge of middle portion in the first Knucklebone of the big in plantar plantar, solar plexus is  in end of the first metatarsal bone in foot and reflection of the spinal cord is in the inner edge of the foot, starting from the end of the first Knucklebone of the thumb  and leads to heel. The total intervention time will be 40 minutes for both legs (20 minutes per foot), within three consecutive days. Intervention 2: The  intervention in the placebo group includes the preparation and heating with a towel and massage the legs and it is done within three consecutive days and takes 40 minutes for both legs (20 minutes per foot). Intervention 3: In the control group, no intervention will be applied. This group will only receive routine care.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elalel Ruhi Rahim Begloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6693 3600</telephone>
        <email>fnm@sina.tums.ac.ir e-ruhi@razi.tums.ac.ir</email>
        <affiliation>Faculty of Nursing and Midwifery - Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Farideh Bastani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6693 3600</telephone>
        <email>f-bastani@tums.ac.ir</email>
        <affiliation>Faculty of Nursing and Midwifery - Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Nulliparous mothers with cesarean section and hospitalized for three full days ; mothers with the age of 20-35 years old; mothers should be literate; mothers with no serious physical and psychological disorders; mothers with no tissue damage on their feet; mothers with gestational age of 30-37 weeks;  mothers with preterm neonate hospitalized in NICU; the newborns have to be breastfed. &#13;
Exclusion criteria: -mothers with no willingness to participate in the trial anymore; mothers with less than three full days hospitalization; mothers who will develop serious health conditions during the trial; mothers who will develop a tissue damage on their feet, during the intervention; mothers who give birth with gestational age of less than 30 weeks; initiating formula feeding in the neonates, for any reasons.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F48.8</hc_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified neurotic disorders</hc_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Foot reflexology massage" or "reflexology" iwill be done for the intervention group which include three stages: preparation, heating with a 15-step techniques and massage techniques on reflex points of the pituitary, spinal cord  and solar plexus .reflection of the pituitary is in inner edge of middle portion in the first Knucklebone of the big in plantar plantar, solar plexus is  in end of the first metatarsal bone in foot and reflection of the spinal cord is in the inner edge of the foot, starting from the end of the first Knucklebone of the thumb  and leads to heel. The total intervention time will be 40 minutes for both legs (20 minutes per foot), within three consecutive days.</i_keyword>
      <i_keyword>The  intervention in the placebo group includes the preparation and heating with a towel and massage the legs and it is done within three consecutive days and takes 40 minutes for both legs (20 minutes per foot)</i_keyword>
      <i_keyword>In the control group, no intervention will be applied. This group will only receive routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety intensity. Timepoint: pre and post intervention (before the initiation of first intervention and after the 3rd day of intervention). Method of measurement: Spielberger State Anxiety Inventory.</prim_outcome>
      <prim_outcome>Fatigue intensity. Timepoint: pre and post intervention (before the initiation of first intervention and after the 3rd day of intervention). Method of measurement: visual  analoge scale for fatigue.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pulse. Timepoint: Once before and once after the third day of intervention and within 10 minutes afte intrventionr. Method of measurement: According to minutes using the standard digital clock.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Once before and once after the third day of intervention and within 10 minutes after intervention. Method of measurement: Mercury blood pressure devices (Richter).</sec_outcome>
      <sec_outcome>Breathing. Timepoint: Once before and once after the third day of intervention and within 10 minutes afte intrvention. Method of measurement: According to minutes using the standard digital clock.</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>Vice chancellor for research Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-05-24</approval_date>
        <contact_name>Faculty of Nursing and Midwifery- Tehran University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. ,1419733171, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
