<?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>IRCT201201038606N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-05-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences and Health care Services</primary_sponsor>
      <public_title>Effects of foot  massage on anxiety and blood pressure</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot massage on anxiety and blood pressure in hypertensive patients Referred to cardiac specialty hospitals clinics affiliated to Tehran University of Medical Sciences in1390</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9108</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Anxiety. Condition 2: High blood pressure.</hc_freetext>
      <i_freetext>Intervention 1: In control group, validated Spielberger questionnaire will be completed to assess the level of manifest and latent anxiety in 2 steps (in first visit and see after a month) and research teammate (he doesn’t know who is in case or control group)  will control and record blood pressure and the rest of vital signs. Intervention 2: Intended intervention is Thai reflexology foot massage that Participants in the study will be massaged in 1 month, 2 times a week; each session lasting one hour in massage therapy center has been considered. Massage therapy in this center will be did free by a Massager who has massage therapy degree that is approved by the Ministry of Health, Thailand and also he is member of the traditional medicine group, brightest talents center of Tehran University of Medical Sciences. So that after the person entering in the massage center, to change clothes and Washing and disinfecting legs will go to special washing and changing clothes room. After that, the feet will be dried and the person will sit down on a massage chair. The massager after doing a series of specific movements on the left foot starts to do massage with foot massage special oil and cream. Then with using a special timber called a steak, specific actions will be done on foot. Then Massage oils and creams are used again. After several movements, the person is given foot massage to above the knee. After this step, the left foot is wrapped in towel. Right foot is performed massage as the left foot. Then somewhere of the left foot is squeezed to massage effects be moved to the whole body (reflexology). And after that somewhere of the right foot is squeezed as left foot. Then on both feet simultaneously perform certain movements and massage will be completed. Before and after the each massage session Systolic and diastolic blood pressure will be controlled and will be recorded in a chart by researcher. Also, with using a 100 mm visual analog scale, patient’s relaxation feeling will be determined by him. After a month, validated Spielberger questionnaire will be completed to assess the level of manifest and latent anxiety and research teammate (he doesn’t know who is in case or control group) will control and record blood pressure and the rest of vital signs.</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>Tahereh Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Nosrat street, Tohid square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6105 4323</telephone>
        <email>najafi_t@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences and Health care Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahereh Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Nosrat street, Tohid square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6105 4323</telephone>
        <email>najafi_t@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences and Health care Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1-    Hypertensive patients with at least 2 years experience with a minimum pressure of 140/90&#13;
2-   Without any history of mental disorders and disability.&#13;
3-   Patients are in the age group 40-65&#13;
4- Patient is physically able to participate in the intervention until the end of it.&#13;
5- Preferably they live in Tehran.&#13;
Exclusion criteria:&#13;
1-Any history of cancer, gout, bone tuberculosis, autoimmune, severe knee arthritis, rheumatism, chemotherapy, bone fracture in the knee area down to last 2 years, any history of  recent surgery to last 2 years, history of cardiac surgery to last 5 years (all of them prevent damages due to the participants during their massage)&#13;
2- Lossing any of  Inclusion criteria.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>A disorder characterized by a partial or complete loss of the normal integration between memories of the past, awareness of identity and immediate sensations, and control of bodily movements (see F44.-), but arising as a consequence of an organic disorder</hc_keyword>
      <hc_keyword>High blood pressure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In control group, validated Spielberger questionnaire will be completed to assess the level of manifest and latent anxiety in 2 steps (in first visit and see after a month) and research teammate (he doesn’t know who is in case or control group)  will control and record blood pressure and the rest of vital signs.</i_keyword>
      <i_keyword>Intended intervention is Thai reflexology foot massage that Participants in the study will be massaged in 1 month, 2 times a week; each session lasting one hour in massage therapy center has been considered. Massage therapy in this center will be did free by a Massager who has massage therapy degree that is approved by the Ministry of Health, Thailand and also he is member of the traditional medicine group, brightest talents center of Tehran University of Medical Sciences. So that after the person entering in the massage center, to change clothes and Washing and disinfecting legs will go to special washing and changing clothes room. After that, the feet will be dried and the person will sit down on a massage chair. The massager after doing a series of specific movements on the left foot starts to do massage with foot massage special oil and cream. Then with using a special timber called a steak, specific actions will be done on foot. Then Massage oils and creams are used again. After several movements, the person is given foot massage to above the knee. After this step, the left foot is wrapped in towel. Right foot is performed massage as the left foot. Then somewhere of the left foot is squeezed to massage effects be moved to the whole body (reflexology). And after that somewhere of the right foot is squeezed as left foot. Then on both feet simultaneously perform certain movements and massage will be completed. Before and after the each massage session Systolic and diastolic blood pressure will be controlled and will be recorded in a chart by researcher. Also, with using a 100 mm visual analog scale, patient’s relaxation feeling will be determined by him. After a month, validated Spielberger questionnaire will be completed to assess the level of manifest and latent anxiety and research teammate (he doesn’t know who is in case or control group) will control and record blood pressure and the rest of vital signs.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: 2 times. Once before the first intervention and once after the last intervention. Method of measurement: standard Spielberger's questionnaire.</prim_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Before and after each massage session. Method of measurement: According mmHg using a mercury sphygmomanometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pulse. Timepoint: Before and after each massage session. Method of measurement: Enumeration.</sec_outcome>
      <sec_outcome>Relaxation feeling. Timepoint: Before and after each massage session. Method of measurement: 100-mm visual analog scale.</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 and Health care Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-04-21</approval_date>
        <contact_name>School of Nursing and Midwifery, Tehran University of Medical Sciences and Health care Services</contact_name>
        <contact_address>School of Nursing and Midwifery, Nosrat Street, Tohid Square, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
