<?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>IRCT20141127020108N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-12</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of lavender (Lavandula angustifolia)  inhalation aroma therapy on stress, anxiety and depression of addicts</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of lavender (Lavandula angustifolia)  inhalation aroma therapy on stress, anxiety and depression of addicts under treatment hospitalized in the addiction wards</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84223</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization with size of 4. Randomization unit: individual. Randomization tool: Random allocation software. Random chain concealment is by placing participants' codes in opaque envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Drug addiction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the Intervention group, the samples participating in the study were subjected to aromatherapy with lavender essential oil for 3 days at 10 am and 6 pm. Thus, the researcher drops 2 drops of lavender essential oil (product of Barij Essential Oil Company, Kashan) with a dropper on a sterile cloth measuring 10 cm by 10 cm and attaches it to the collar of the research unit's clothing with a clip at a distance of 20 cm from the nose. Immediately before and after the end of the intervention, their stress, anxiety, and depression levels are measured using a questionnaire. Intervention 2: Control group: The control group will be hospitalized in the ward, receive routine treatments and care, and like the intervention group, their levels of stress, anxiety, and depression will be assessed using questionnaires immediately before the study and three days after the start of the study.</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 I haven't decided yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Musarezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazar Jarib Street, Isfahan University of Medical Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>musarezaie@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Musarezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazar Jarib Street, Isfahan University of Medical Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>musarezaie@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 years and above
be able to read and write in Persian.
Consent to participate in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having a history of allergic rhinitis, eczema, or known respiratory problems such as asthma
Having a cold or anything else that affects a person's ability to smell.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z63.72</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alcoholism and drug addiction in family</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the Intervention group, the samples participating in the study were subjected to aromatherapy with lavender essential oil for 3 days at 10 am and 6 pm. Thus, the researcher drops 2 drops of lavender essential oil (product of Barij Essential Oil Company, Kashan) with a dropper on a sterile cloth measuring 10 cm by 10 cm and attaches it to the collar of the research unit's clothing with a clip at a distance of 20 cm from the nose. Immediately before and after the end of the intervention, their stress, anxiety, and depression levels are measured using a questionnaire.</i_keyword>
      <i_keyword>Control group: The control group will be hospitalized in the ward, receive routine treatments and care, and like the intervention group, their levels of stress, anxiety, and depression will be assessed using questionnaires immediately before the study and three days after the start of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress. Timepoint: Immediately before and three days after the start of the intervention. Method of measurement: Stress, Anxiety, Depression Questionnaire (DASS-21).</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Immediately before and three days after the start of the intervention. Method of measurement: Stress, Anxiety, Depression Questionnaire (DASS-21).</prim_outcome>
      <prim_outcome>Depression. Timepoint: Immediately before and three days after the start of the intervention. Method of measurement: Stress, Anxiety, Depression Questionnaire (DASS-21).</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-10</approval_date>
        <contact_name>Research Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan</contact_name>
        <contact_address>sfahan University of Medical Sciences, Hezar Jarib St, Isfahan, Isfahan Province, Iran Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
