<?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>IRCT201308024655N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-24</date_registration>
      <primary_sponsor>Kashan Medical University</primary_sponsor>
      <public_title>Compare the effect of pranayama breathing and hand reflexology on anxiety in patients undergoing coronary angiography</public_title>
      <acronym></acronym>
      <scientific_title>The effects of pranayama Sukha and hand reflexology on anxiety and hemodynamic status of patients undergoing coronary angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4986</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Hand reflexology intervention group, patients in the sitting position, the leg to the wrist, palm, fingers on the hands and the patient is 8 to 10 times by researcher massage. To perform this technique washed with warm water and massage therapist's hands with thumb and first left hand then right hand starts patient. The reflection of Cardiology includes (1) the solar plexus and diaphragm located in the center of the palm at the base of the tip of the middle finger,(2) thyroid and parathyroid glands are located on the side  of rule of thumb,(3) lung in hand on the tip of the middle finger and ring finger, ring finger (4) heart in the palm of the hand below the lower lobe small, (5)- adrenal glands located above the tendon thumb about one-third the distance between the base of the index finger and wrist kidney (6)- located in the interior index finger is directly under the thumb tendon. Each of the reflection by the researcher thumb is pressed so that the patient felt the pressure but not pain. The massage is performed to the number specified in the image below. Reflection points 14 times in succession in a clockwise direction without being interrupted for a period of skin contact being massaged. Intervention 2: Pranayama breathing intervention Sukha: First, a general explanation of the method is given. Then the patient in the sitting position so that his hands resting on the thighs perfect legs, it is. The patient is asked to close their eyes to get a better internal focus. Svkha pranayama and relaxation through the nasal passages and on a regular basis with the use of lower, middle and upper lung sequentially performed for each inhalation and exhalation. Time to inhale and exhale in this type of breathing and respiratory rate of 6 per minute. Researchers using hypnosis spoken over the management of the patient's breathing, conscious use of all parts of the lungs provides patient. The patient is said to not think about anything except your breathing, breathe when doing strength and energy into your lungs and exhaled with action, tension, stress and disease out of the body. RR 6 times per minute with equal respiration by measuring the time taken by the stopwatch. Intervention 3: In addition to the routine care of patients in the control group of patients undergoing coronary angiography by simple massage will be 8 to 10 times.</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>Taghadosi Mohsen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arctic Blvd Ravandi - Kashan University of Medical Sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159/81151</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>Taghadosi_m@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Taghadosi Mohsen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arctic Blvd Ravandi - Kashan University of Medical Sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159/81151</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>Taghadosi_m@kaums.ac.ir</email>
        <affiliation>Faculty of Nursing &amp; Midwifery,Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
willing to participate in the study; for the first time the case  is to be hospitalized for coronary angiography;  having the hemodynamic stability  prior to angiography; no  history of heart infarction and  surgery; no  current history of  addiction to narcotics;  no previous use of sedatives or anxiolytics,e.g propranolol, over 72 hours; no history of epilepsy and the known disorders of thyroid;  having no local problems at the point of reflexology in hand; no positive history for pulmonary disorders; having an anxiety scare of &gt;= 43.&#13;
 Exclusion criteria:&#13;
 unwillingness to participate in study;  intolerance to intervention, unstable vital signs during the study and the occurance of any problems that the patient is no longer able to continue participating in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Hand reflexology intervention group, patients in the sitting position, the leg to the wrist, palm, fingers on the hands and the patient is 8 to 10 times by researcher massage. To perform this technique washed with warm water and massage therapist's hands with thumb and first left hand then right hand starts patient. The reflection of Cardiology includes (1) the solar plexus and diaphragm located in the center of the palm at the base of the tip of the middle finger,(2) thyroid and parathyroid glands are located on the side  of rule of thumb,(3) lung in hand on the tip of the middle finger and ring finger, ring finger (4) heart in the palm of the hand below the lower lobe small, (5)- adrenal glands located above the tendon thumb about one-third the distance between the base of the index finger and wrist kidney (6)- located in the interior index finger is directly under the thumb tendon. Each of the reflection by the researcher thumb is pressed so that the patient felt the pressure but not pain. The massage is performed to the number specified in the image below. Reflection points 14 times in succession in a clockwise direction without being interrupted for a period of skin contact being massaged</i_keyword>
      <i_keyword>Pranayama breathing intervention Sukha: First, a general explanation of the method is given. Then the patient in the sitting position so that his hands resting on the thighs perfect legs, it is. The patient is asked to close their eyes to get a better internal focus. Svkha pranayama and relaxation through the nasal passages and on a regular basis with the use of lower, middle and upper lung sequentially performed for each inhalation and exhalation. Time to inhale and exhale in this type of breathing and respiratory rate of 6 per minute. Researchers using hypnosis spoken over the management of the patient's breathing, conscious use of all parts of the lungs provides patient. The patient is said to not think about anything except your breathing, breathe when doing strength and energy into your lungs and exhaled with action, tension, stress and disease out of the body. RR 6 times per minute with equal respiration by measuring the time taken by the stopwatch</i_keyword>
      <i_keyword>In addition to the routine care of patients in the control group of patients undergoing coronary angiography by simple massage will be 8 to 10 times</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before intervention - intervention after half an hour - an hour after the intervention. Method of measurement: Trait Anxiety Inventory.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: 10 minutes before the intervention - after intervention - 5 minutes after the procedure - 30 minutes after the intervention. Method of measurement: Millimeters of mercury.</prim_outcome>
      <prim_outcome>Pulse. Timepoint: 10 minutes before the intervention - after intervention - 5 minutes after the procedure - 30 minutes after the intervention. Method of measurement: The number in minutes.</prim_outcome>
      <prim_outcome>Breathing. Timepoint: 10 minutes before the intervention - after intervention - 5 minutes after the procedure - 30 minutes after the intervention. Method of measurement: The number in minutes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart disrhythm. Timepoint: Before intervention - within 30 minutes after the intervention. Method of measurement: Using the  List by  cardiac monitoring.</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>Kashan Medical University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-09-23</approval_date>
        <contact_name>Kashan University of Medical Sciences</contact_name>
        <contact_address>Arctic Blvd Ravandi - Kashan University of Medical Sciences Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
