<?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>IRCT20210523051370N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-12</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Lavender Aromatherapy on Nurses' Death Anxiety and Sleep Quality</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Inhalation Aromatherapy with Lavender Essential Oil on Death Anxiety and Sleep Quality in Emergency Department Nurses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66733</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: The experimental group will receive dark colored bottles containing the required amount of lavender oil (Lavandula angustifolia) procured from the Barij Essence Pharmaceutical Company (Kashan, Iran) along with a dropper. The control group will also receive dark colored bottles containing the required amount of paraffin along with a dropper. For two weeks, the experimental group will drip 2 drops of lavender oil on a cotton ball every night before going to sleep, take 2-3 deep breaths, and then attach the cotton ball to the collar of their clothes at a distance of 10 cm from their nose. The control group will also drip 2 drops of paraffin on a cotton ball every night for two weeks before going to sleep, take 2-3 deep breaths, and then attach the cotton ball to the collar of their clothes at a distance of 10 cm from their nose, Randomization description: Sixty-four nurses will be randomly assigned to either the experimental group or the control group. The randomization sequence will be computer generated with the permuted block technique and a 1:1 allocation ratio with allocations concealed in sealed, opaque, sequentially numbered envelopes, Blinding description: The outcome assessor will be blinded to the allocated intervention. Nurses will be advised not to share it with the outcome assessor if they identify the intervention being received (lavender oil or paraffin). Glass bottles containing lavender oil and paraffin will be identical in size, color and shape, being prepared by a person not aware of the research objectives. The same person will deliver the bottles to the nurses of the two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Death Anxiety. Condition 2: Sleep quality.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The experimental group will receive bottles containing the required amount of lavender oil along with a dropper. For two weeks, they will drip 2 drops of lavender oil on a cotton ball every night before going to sleep, take 2-3 deep breaths, and then attach the cotton ball to the collar of their clothes at a distance of 10 cm from their nose. Intervention 2: Control group: The control group will receive bottles containing the required amount of paraffin along with a dropper. For two weeks, they will drip 2 drops of paraffin on a cotton ball every night before going to sleep, take 2-3 deep breaths, and then attach the cotton ball to the collar of their clothes at a distance of 10 cm from their nose.</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 To keep sample data confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Seyed Afshin Shorofi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical Sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 911 676 6280</telephone>
        <email>ashorofi@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Seyed Afshin Shorofi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical Sciences</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4846715793</zip>
        <telephone>+98 11 3336 7342</telephone>
        <email>ashorofi@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being willing to participate in the study
Being a registered nurse
Having a minimum of 6 months of work experience in emergency departments
Having a mobile phone</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of being allergic to lavender
Having a history of being allergic to essential oils and perfumes
Being pregnant and breastfeeding
Taking sedatives and hypnotics
Being addicted to drugs and alcohol
Suffering from acute respiratory diseases, dyspnea, or chronic cough
Using any form of aromatherapy with essential oils
Simultaneously participating in other studies</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
      <hc_code>F51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
      <hc_keyword>Sleep disorders not due to a substance or known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The experimental group will receive bottles containing the required amount of lavender oil along with a dropper. For two weeks, they will drip 2 drops of lavender oil on a cotton ball every night before going to sleep, take 2-3 deep breaths, and then attach the cotton ball to the collar of their clothes at a distance of 10 cm from their nose.</i_keyword>
      <i_keyword>Control group: The control group will receive bottles containing the required amount of paraffin along with a dropper. For two weeks, they will drip 2 drops of paraffin on a cotton ball every night before going to sleep, take 2-3 deep breaths, and then attach the cotton ball to the collar of their clothes at a distance of 10 cm from their nose.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Death anxiety. Timepoint: T0 (before the intervention); Time 1 (end of the first week with aromatherapy); Time 2 (end of the second week with aromatherapy);- Follow-up (end of the third week). Method of measurement: Death Anxiety Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleep quality. Timepoint: T0 (before the intervention); Time 1 (end of the first week with aromatherapy); Time 2 (end of the second week with aromatherapy);  Follow-up (end of the third week). Method of measurement: Pittsburgh Sleep Quality Index.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-22</approval_date>
        <contact_name>Bioethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Moalem Square, Sari, Mazandaran Province Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
