<?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>IRCT20221227056941N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-01</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Investigating of the Effect of Aromatherapy with lavender on the Satisfaction, Pain and Physiological indicators of Patients undergoing endoscopic retrograde</public_title>
      <acronym></acronym>
      <scientific_title>Investigating of the Effect of Aromatherapy with lavender on the Satisfaction, Pain and Physiological indicators of Patients undergoing endoscopic retrograde cholangiopancreatography (ERCP)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67762</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize and assign people to the intervention and control groups, the function of random numbers will be used, so that in the Excel software, the groups are first entered in the form of A and B below each other in one column; Because the number of samples in each group is set to 40, therefore, 40, B and A should be entered below each other and in order. In the opposite column, random numbers are generated using the RAND command. In the next step, using the sort command, the generated random numbers are sorted from small to large or vice versa, which changes the order of the groups, A, B. Using the new order, people are assigned to different groups, Blinding description: Both the control and observation groups do not know the type of scent that is used, and instead of writing the name on the bottle of solution used, the number one and two is written. The researcher is aware of this numbering. The solutions are used in a closed glass bottle that is the same in terms of color and volume of the solution. Also, in order to carry out the intervention, the control and intervention groups are in separate rooms.</study_design>
      <phase>N/A</phase>
      <hc_freetext>آندوسکوپی دستگاه گوارش.</hc_freetext>
      <i_freetext>Intervention 1: Before the endoscopy, four drops of lavender essential oil with a concentration of 2% (product of Zardband company) will be dripped on sterile gauze and placed on the chest of patients in the intervention group, and they will be asked to inhale it for 30 minutes. Intervention 2: Control group: Before the endoscopy, four drops of normal saline are dripped on sterile gauze and placed on the chest of control group patients, and they will be asked to inhale it for 30 minutes.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Based on the objectives in the proposal, the level of satisfaction, pain and physiological index before and after aromatherapy are reported and some individual information mentioned in the variable section.

When:
November 1401

To whom:
Researchers, Shahid Beheshti University of Medical Sciences, study subjects, university and hospital researchers

Conditions:
After analysis, the data are available to others through publication in scientific research journals.

Where to obtain:
Roya rajabi .E-mail: rajabiroya00@sbmu.ac.ir.
phone number 09123313745. No 135., Helal Ahmar9 Ave., Nehzat Blv

How to obtain:
Information will be available through printing the article. But if a person wants more and additional information, he can express his request through email, phone and in person. Then, according to the amount and type of data that will be considered, information is provided.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roya Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 135, Helal Ahmar9 Ave., nehzat Blv</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514864441</zip>
        <telephone>+98 23 3344 4329</telephone>
        <email>rajabiroya00@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roya Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 135, Helal Ahmar9 Ave., nehzat Blv</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514864441</zip>
        <telephone>+98 23 3344 4329</telephone>
        <email>rajabiroya00@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No history of drug sensitivity
Having the necessary cooperation to perform the procedure
Not receiving analgesics before and after the procedure in the control and intervention groups
The same anesthesia protocol
Not having a smell problem</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any allergy to lavender</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K83.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obstruction of bile duct</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Before the endoscopy, four drops of lavender essential oil with a concentration of 2% (product of Zardband company) will be dripped on sterile gauze and placed on the chest of patients in the intervention group, and they will be asked to inhale it for 30 minutes.</i_keyword>
      <i_keyword>Control group: Before the endoscopy, four drops of normal saline are dripped on sterile gauze and placed on the chest of control group patients, and they will be asked to inhale it for 30 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Satisfaction. Timepoint: Before and after the intervention. Method of measurement: Satisfaction questionnaire.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before and after the intervention. Method of measurement: Pain Visual Numerical Questionnaire.</prim_outcome>
      <prim_outcome>Physiological index. Timepoint: Before and after the intervention. Method of measurement: دستگاه پالس اکسی متری.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Allergy to lavender. Timepoint: After intervention for 3 days. Method of measurement: Examining side effects caused by medication by asking the patient.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-24</approval_date>
        <contact_name>Ethics committee in research of pharmacy, nursing and midwifery faculties - Shahid Beheshti Universi</contact_name>
        <contact_address>No. 135, Helal Ahmar9 Ave., nehzat Blv Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
