<?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>IRCT20240609062060N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-18</date_registration>
      <primary_sponsor>Khomein Faculty of Medical Science</primary_sponsor>
      <public_title>Effect of virtual reality, music therapy and aromatherapy on anxiety in cardiac patient</public_title>
      <acronym></acronym>
      <scientific_title>Comparative investigation of virtual reality, music therapy and aromatherapy on anxiety in cardiac care unit patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78477</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done based on the table of random numbers.In this way, in the beginning, all the research units were numbered, then the RandBetween function was used by Excel software,and between the number 1 and 100 ,random numbers were obtained,and then the first 25 random numbers in the first study group, the second 25 random numbers in the second study group ,the third 25 random numbers in the third study group and the fourth 25 random numbers are placed in the control group, Blinding description: The research units are unaware of the type of intervention in other groups.The data analyst also has access to the raw data.</study_design>
      <phase>3</phase>
      <hc_freetext>Stress of patients Hospitalised in cardiac care unit.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: Virtual reality,including 25 patients after completing  Spielberger questionary by using special virtual reality glasses, they see relaxing images for 15 minutes, and after 20 minutes break they complet the Spielberger questionary for the second time. Intervention 2: Second Intervention group: The music group including 25 patients after completing Spielberger questionary for 15 minutes they listen to silent music under the title ((Soft silent mix)) downloaded from the site nicmusic.net and after 20 minutes break they complet the Spielberger questionary for the second time. Intervention 3: Third Intervention group: The aromatherapy group including 25 patients after completing Spielberger questionary  smell the essential oil of Bahar Naranj plant produced by Adonis Gol Daru company for 15 minutes.and after 20 minutes break they complet the Spielberger questionary for the second time. Intervention 4: Control group: does not receive any intervention they complete the Spielberger questionnaire  two times with 35 minutes interval.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is It is decided after completing the trial and seeing the result</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Rezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Blvd.,Khomein town</address>
        <city>Khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۸۸۱۷۴۳۳۶۴</zip>
        <telephone>+98 86 4622 4142</telephone>
        <email>rezaieemail1994@gmail.com</email>
        <affiliation>Khomein University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Rezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Blvd.,Khomein town</address>
        <city>Khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۸۸۱۷۴۳۳۶۴</zip>
        <telephone>+98 86 4622 4142</telephone>
        <email>rezaieemail1994@gmail.com</email>
        <affiliation>Khomein University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Over 18 years of age
Being aware of time, place and people
Having informed consent and completing a written consent form
Having a healthy sense of hearing
Not being sensitive to specific smells, including the smell of perfume, cologne, or specific flowers
Not having any Respiratory problems
No history of mental illness, depression or anxiety that has been diagnosed by a psychiatrist
No history of new crisis such as death of 1st degree relatives, divorce of self or parents in the last 6 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient's refusal to continue participating in the study
The virtual reality, music therapy or aromatherapy becomes unpleasant for the patient
patient's condition becomes critical</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>First Intervention group: Virtual reality,including 25 patients after completing  Spielberger questionary by using special virtual reality glasses, they see relaxing images for 15 minutes, and after 20 minutes break they complet the Spielberger questionary for the second time.</i_keyword>
      <i_keyword>Second Intervention group: The music group including 25 patients after completing Spielberger questionary for 15 minutes they listen to silent music under the title ((Soft silent mix)) downloaded from the site nicmusic.net and after 20 minutes break they complet the Spielberger questionary for the second time.</i_keyword>
      <i_keyword>Third Intervention group: The aromatherapy group including 25 patients after completing Spielberger questionary  smell the essential oil of Bahar Naranj plant produced by Adonis Gol Daru company for 15 minutes.and after 20 minutes break they complet the Spielberger questionary for the second time.</i_keyword>
      <i_keyword>Control group: does not receive any intervention they complete the Spielberger questionnaire  two times with 35 minutes interval</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient's anxiety score in Spielberger questionnaire. Timepoint: Before the intervention and 20 minutes after the intervention. Method of measurement: Spielberger questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Khomein Faculty of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-08-31</approval_date>
        <contact_name>Ethics committee of Khomein Univercity of Medical Sciences</contact_name>
        <contact_address>Azadi Blvd.,Khomein town Khomein Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
