<?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>IRCT201110087067N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-30</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The impact of Benson relaxation on the anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The impact of Benson relaxation on the anxiety of patients experiencing coronary angiography</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>73</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7500</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: How randomization was sealed envelope.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In subject group(relaxation group), the audio file for relaxation exercises will be provided to the patients and the exercises will be performed by the patients simultaneously in the presence of the researcher on the day before angiography.one hour before angiography anxiety levels and vital signs will be recorded immediately before the intervention. They will be received routine care, providing a calm and quiet environment and minimizing the environmental provocations, the patients will be listened to the audio file for relaxation techniques through headphones. In this technique, patients calmly lie on the bed with closed eyes and start to say the relaxing words (Like God; love; etc.) and mean while, deeply inhale through the nose and deeply exhale through the mouth and repeat the desired word in their mind and simultaneously relax their muscles from the fingertips upward until complete relaxation of all the muscles of the body. This condition will be maintained for 20 minutes and this technique was done before the angiography and then anxiety levels and vital signs will be recorded after 30 minutes at the end of relaxation. Intervention 2: Control group: no intervention was done and only received routine care. Anxiety levels and vital signs were measured one hour and 30 minutes before the angiography. There was no intervention and placebo in this group.</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>Homyra Tahmasebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th km of sea Road(Farah Abad)</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+961 133175540</telephone>
        <email>htahmasebi@iausari.ac.ir</email>
        <affiliation>Isamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Homyra Tahmasebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th km of sea Road(Farah Abad)</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 11 3317 5540</telephone>
        <email>hthahmasebi@yahoo.com;htahmasebi@iausari.ac.ir</email>
        <affiliation>Islamic Azad University  Nursing department</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age of 30-90 years; undergoing coronary angiography for the first time; only  undergoing coronary angiography; patients with full consciousness and not in critical conditions and having the ability to speak and hear&#13;
Exclusion criteria: lack of patient consent to continue participation in the study;having received a sedative within the past 8 hours; history of treatment with procedures similar to muscular relaxation and suffering from muscle paralysis.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Specific (isolated) phobias</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In subject group(relaxation group), the audio file for relaxation exercises will be provided to the patients and the exercises will be performed by the patients simultaneously in the presence of the researcher on the day before angiography.one hour before angiography anxiety levels and vital signs will be recorded immediately before the intervention. They will be received routine care, providing a calm and quiet environment and minimizing the environmental provocations, the patients will be listened to the audio file for relaxation techniques through headphones. In this technique, patients calmly lie on the bed with closed eyes and start to say the relaxing words (Like God; love; etc.) and mean while, deeply inhale through the nose and deeply exhale through the mouth and repeat the desired word in their mind and simultaneously relax their muscles from the fingertips upward until complete relaxation of all the muscles of the body. This condition will be maintained for 20 minutes and this technique was done before the angiography and then anxiety levels and vital signs will be recorded after 30 minutes at the end of relaxation.</i_keyword>
      <i_keyword>Control group: no intervention was done and only received routine care. Anxiety levels and vital signs were measured one hour and 30 minutes before the angiography. There was no intervention and placebo in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: one hour and 30 minutes before the angiography. Method of measurement: Spielberger standard questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Hour and 30 minutes before the angiography. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Pulse. Timepoint: Hour and 30 minutes before the angiography. Method of measurement: Physical examination.</sec_outcome>
      <sec_outcome>Respiratory. Timepoint: Hour and 30 minutes before the angiography. Method of measurement: Physical examination.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-13</approval_date>
        <contact_name>Ethics committee of Islamic Azad University Sari Branch</contact_name>
        <contact_address>7th km of sea Road(Farah Abad) Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
