<?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>IRCT20180923041106N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-30</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of music therapy and aromatherapy of chamomile-lavender on fatigue and anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effect of music therapy and aromatherapy of chamomile-lavender on fatigue and anxiety of nurses working in Besat hospital of Sanandaj in 2018</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>132</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34065</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: In this study, Stratified randomization will be used. Randomization is done particularly in each hospital ward as a Stratify. Considering having ten clinical wards as ten stratifies and a sample size of 120 samples, 12samples were considered from each Stratify. Randomized allocation of samples to groups in each Stratify will be applied based on lottery cards numbered 1 to 4 (for each group of three cards) without replacement of cards.assigned to each group and 12 will be allocated to four groups based on each other. From these quotas assigned in each category based on the draw of random numbers, One to four (number of groups) without substitution in each section will be assigned randomly to the groups, Blinding description: The method of blindness in this study is that the second-degree fellow will not be aware of the type of intervention. The first research partner in each of the three intervention groups will take the necessary interventions. The coding of the questionnaire and information registration forms based on the number assigned to the random sampling will be the responsibility of the main investigator. The second collaborator of the research after the end of the interventions, without considering and informing the groups, will refer to the samples for collecting the data based on this code and will be blind to the type of intervention. Also, all questionnaires will be given to the statistical consultant by the original researcher based on the coding, so the statistician will also be blind to the type of intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Fatigue and anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In the first intervention group, the aroma of chamomile-lavender will be used. The aroma of this research will be used the combination of lavender-chamomile 1.5% by inhalation breathing. Chamomile and lavender plants will be provided by Zardvand Pharmaceutical Company. Then, Shahid Beheshti Pharmaceutical Faculty will then extract it by distillation with water, after which it will be diluted 5% in the sesame oil base. This essential oil is prepared for each sample of three drops on a pre-prepared non-absorbent pad and will be inhaled at a distance of 20 cm from the nose for 20 minutes at rest. Intervention 2: Intervention group 2: In the second intervention group, music therapy will be performed. In the music band, the intervention will be such that pre-designated music (traditional, pop, classical) will be selected as desired. Headphones will be used to play music. Music will be played for 20 minutes each time. This intervention will be performed over three consecutive shifts. Intervention 3: Intervention Group 3: For nurses in this group simultaneously inhale the scent of Lavender Chamomile and listen to the desired music. Three drops of lavender chamomile will be prepared on one and a half percent on a pre-prepared, Non-absorbent pad. It will be inhaled at 20 cm from the nose for 20 minutes. From pre-set music (traditional, pop, classical), samples will be played back for 20 minutes. This intervention will be performed over three consecutive shifts. Intervention 4: Control group: Due to the fact that the samples are not sick and nursing, They do not receive any special treatment. Therefore, There is no specific action in the control group, but ethically, After the end of the study, The interventions will be done for the control group.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Zamanifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Besat Hospital, Keshavarz Street , sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6619616776</zip>
        <telephone>+98 878733285910</telephone>
        <email>zamanifarnursing@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jamal Siedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13446-66177</zip>
        <telephone>+98 87 3182 7464</telephone>
        <email>jamal.seidi@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Voluntary participation in the study
Not being in critical condition
No thyroid dysfunction or mental illness such as anxiety
Not taking any anxiety and analgesics during the study
Have at least 6 months of work experience
Not having any history of life events and crises in the last 6 months
Have a sense of smell
Absence of respiratory diseases, asthma and allergic diseases
Non pregnancy, breastfeeding
Having a working shift
No vacation or sick leave during the study
Earn at least a score of 8 from the Beck Anxiety Inventory
No perfume in the day of study
Interest in listening to music</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having allergies</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: In the first intervention group, the aroma of chamomile-lavender will be used. The aroma of this research will be used the combination of lavender-chamomile 1.5% by inhalation breathing. Chamomile and lavender plants will be provided by Zardvand Pharmaceutical Company. Then, Shahid Beheshti Pharmaceutical Faculty will then extract it by distillation with water, after which it will be diluted 5% in the sesame oil base. This essential oil is prepared for each sample of three drops on a pre-prepared non-absorbent pad and will be inhaled at a distance of 20 cm from the nose for 20 minutes at rest.</i_keyword>
      <i_keyword>Intervention group 2: In the second intervention group, music therapy will be performed. In the music band, the intervention will be such that pre-designated music (traditional, pop, classical) will be selected as desired. Headphones will be used to play music. Music will be played for 20 minutes each time. This intervention will be performed over three consecutive shifts.</i_keyword>
      <i_keyword>Intervention Group 3: For nurses in this group simultaneously inhale the scent of Lavender Chamomile and listen to the desired music. Three drops of lavender chamomile will be prepared on one and a half percent on a pre-prepared, Non-absorbent pad. It will be inhaled at 20 cm from the nose for 20 minutes. From pre-set music (traditional, pop, classical), samples will be played back for 20 minutes. This intervention will be performed over three consecutive shifts</i_keyword>
      <i_keyword>Control group: Due to the fact that the samples are not sick and nursing, They do not receive any special treatment. Therefore, There is no specific action in the control group, but ethically, After the end of the study, The interventions will be done for the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue severity. Timepoint: Before the intervention and after three shifts. Method of measurement: Krupp Fatigue Severity Scale et al.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention and after three shifts. Method of measurement: Beck anxiety inventory.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-04</approval_date>
        <contact_name>Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Kurdistan University of Medical Sciences, after Qods Hospital Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
