<?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>IRCT2016110317197N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-11-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>"The impact of environmental factors (sound, light, color) in waiting units on  the physiological indices of anxiety in patients undergoing coronary angiography"</public_title>
      <acronym></acronym>
      <scientific_title>"The impact of environmental factors (sound, light, color) in waiting units on  the physiological indices of anxiety in patients undergoing coronary angiography"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-11-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15872</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Samples of this group, according to hospital routine, will enter into a single-bed unit that has no window because it is located at the end of the waiting hall and its lighting is financed by the artificial light sources of the hall. In this unit, all appliances are white. It will explain to the patients that he/she would wait in this unit for about 60 min before being transferred to the angiography unit. Nurse will come immediately after the patient enter to this unit, as well as 30 and 60 min after that, for the checking of physiological indices, before being sent to the catheterization lab. Intervention 2: Intervention group 1 (sound): This unit is along the previous unit and has similar physical conditions with it. But, a media player and a headphone will placed at the bedside. After a similar explanation to the patient by the researcher, patients will asked to select a natural sound according to their preferences from the list in media player. Thereafter, they will listen to it using headphones until the end of 60 min; this will followed by their transfer to the angiography section. Intervention 3: Intervention group 2 (sound, light): The characteristics of this unit is the same with the previous unit and the difference is that it has a window that opened to the courtyard of the hospital. Thus, the lightening of the unit will provided by natural daylight. Patients of this group will receive similar guidance with two other groups but they will also requested not to close the curtains and to allow the light shine in the unit. Intervention 4: Intervention group 3 (sound, light, color): In this unit, in addition to the availability of media player and having the same size of window as the previous unit, the blue color will used for sorting the suites.</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>Sara Aamanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The Faculty of Nursing and Midwifery of Tehran University of Medical Scienses, Nosrat Street, Tohid Squre, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3724 9584</telephone>
        <email>s-amaniyan@razi.tums.ac.ir</email>
        <affiliation>Nursing and Midwifery school of Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Abbasi Dolatabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The Faculty of Nursing and Midwifery of Tehran University of Medical Scienses, Nosrat Street, Tohid Squre, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>z-abbasi@razi.tums.ac.ir</email>
        <affiliation>Nursing and Midwifery school of Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria: patients between the ages of 18 to 65 years who underwent coronary angiography for the first time; These patients had no hearing deficit and no major visual problem; no consumption of any sedative or anti-anxiety used; except a single dose of Oxazepam according to the prescription of physicians in the last 24 h; no addiction; no anxiety disorders and all samples had full consciousness and were not in critical condition. The exclusion criteria: If any sudden changes was observed in the physiological parameters of anxiety in the patients or their unwillingness to continue to cooperate, they were excluded from the study at any time they wanted.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Samples of this group, according to hospital routine, will enter into a single-bed unit that has no window because it is located at the end of the waiting hall and its lighting is financed by the artificial light sources of the hall. In this unit, all appliances are white. It will explain to the patients that he/she would wait in this unit for about 60 min before being transferred to the angiography unit. Nurse will come immediately after the patient enter to this unit, as well as 30 and 60 min after that, for the checking of physiological indices, before being sent to the catheterization lab.</i_keyword>
      <i_keyword>Intervention group 1 (sound): This unit is along the previous unit and has similar physical conditions with it. But, a media player and a headphone will placed at the bedside. After a similar explanation to the patient by the researcher, patients will asked to select a natural sound according to their preferences from the list in media player. Thereafter, they will listen to it using headphones until the end of 60 min; this will followed by their transfer to the angiography section.</i_keyword>
      <i_keyword>Intervention group 2 (sound, light): The characteristics of this unit is the same with the previous unit and the difference is that it has a window that opened to the courtyard of the hospital. Thus, the lightening of the unit will provided by natural daylight. Patients of this group will receive similar guidance with two other groups but they will also requested not to close the curtains and to allow the light shine in the unit.</i_keyword>
      <i_keyword>Intervention group 3 (sound, light, color): In this unit, in addition to the availability of media player and having the same size of window as the previous unit, the blue color will used for sorting the suites.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Immediately after the arrival to the units,  as well as 30 and 60 min after that. Method of measurement: Monitoring of anxiety physiological indices.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hemodynamic changes. Timepoint: Immediately after the arrival to the units,  as well as 30 and 60 min after that. Method of measurement: Monitoring of anxiety physiological indices.</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>2016-11-01</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, Qods Street, Keshavarz Street, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
