<?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>IRCT20170124032147N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-25</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Assessing the effect of aromatherapy with Citrus aurantium(neroli oil) and music on the level of anxiety  and physiological  indexes  in patients undergoing colonoscopy</public_title>
      <acronym></acronym>
      <scientific_title>Compare the effect of aromatherapy with Citrus aurantium and music on the level of anxiety  and physiological  indexes  in patients undergoing colonoscopy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31263</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The research samples were randomly assigned to the six-block questionnaire, which were performed by the software. Sixth permutations were determined using the three letters A for the control group, the letter B for the intervention group with music and the letter C for the intervention group with Citrus aurantium, and using the randomized method, six permutations in the triple groups were chosen.</study_design>
      <phase>3</phase>
      <hc_freetext>colon disease.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: The method of intervention were done as: On the morning of the procedure, before the intervention, the level of anxiety and physiological indices are measured. Then, 2 drops of essential oil are stained with 2 * 2 gases and attached to the collar of the patients and continue for half an hour, and then the level of anxiety and physiological indicators immediately after the end of aromatherapy and again immediately before colonoscopy and before Sedative infusion is measured. Intervention 2: Second intervention group: The method of intervention were done as: On the morning of the procedure, before the intervention, the level of anxiety and physiological indices are measured. Then the indomitable music (called relaxing music by Dr. Arendestein called Relaxation in Dream) is broadcast to the patient for half an hour using the headphones, after the intervention, also immediately before the procedure, the level of anxiety and physiological parameters of the size Is measured. Intervention 3: Control group: In the control group, no interventions are performed on patients and they will receive routine nursing care.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeede Rostami Daronkola</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>(Nusrat East) Dr. Mirmohani Ave., Tohid Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 11 3231 6406</telephone>
        <email>rostamisaeede@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeede Rostami Daronkola</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nusrat East Ave., Tohid Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 11 3231 6406</telephone>
        <email>rostamisaeede@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age of 18-65 years old;
without history of mental illnesses, headacheas, migraines, asthma, heart disease,respiratory disease and olfactory dysfunction, allergy to the odor of plants specially plants of Citrus aurantium,
the first experience of colonoscopy;
willingness to participant in the study,
ability to speak and comprehend Persian;
being conscious,
Do not take anti-anxiety drugs</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria: refuse to continue corporation in this study,
cancellation of colonoscopy procedure on the scheduled day,
outbreak of problems such as headaches that cause interruption of the intervention.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K52.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Noninfective gastroenteritis and colitis, unspecified</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>First intervention group: The method of intervention were done as: On the morning of the procedure, before the intervention, the level of anxiety and physiological indices are measured. Then, 2 drops of essential oil are stained with 2 * 2 gases and attached to the collar of the patients and continue for half an hour, and then the level of anxiety and physiological indicators immediately after the end of aromatherapy and again immediately before colonoscopy and before Sedative infusion is measured.</i_keyword>
      <i_keyword>Second intervention group: The method of intervention were done as: On the morning of the procedure, before the intervention, the level of anxiety and physiological indices are measured. Then the indomitable music (called relaxing music by Dr. Arendestein called Relaxation in Dream) is broadcast to the patient for half an hour using the headphones, after the intervention, also immediately before the procedure, the level of anxiety and physiological parameters of the size Is measured.</i_keyword>
      <i_keyword>Control group: In the control group, no interventions are performed on patients and they will receive routine nursing care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: in the morning of the day of colonoscopy prior to the intervention, immediately after the intervention, and immediately before colonoscopy. Method of measurement: Visual Analog Scale questionnaire.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: in the morning of the day of colonoscopy prior to the intervention, immediately after the intervention, and immediately before colonoscopy( after theintervention). Method of measurement: Radial puls count through touch.</prim_outcome>
      <prim_outcome>Respiration rate. Timepoint: in the morning of the day of colonoscopy prior to the intervention, immediately after the intervention, and immediately before colonoscopy( after theintervention). Method of measurement: Enumeration.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-20</approval_date>
        <contact_name>Ethical Commitee of Tehran Factulty of Nursing and Midwifery and Rehabilitation</contact_name>
        <contact_address>Tehran, Factulty of Nursing and Midwifery, Nosrat Sharghi,  Tohid Square, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
