<?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>IRCT20180218038783N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-08</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>"Effectiveness of Aromatherapy with Rosa damascena Mill. in treatment  of postpartum depression"</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of aromatherapy with Rosa damascena Mill. to relieve the symptoms of postpartum depression in primiparous women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49980</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible individuals are randomly divided into four groups (permuted block randomization) and open lable in one of two treatment groups A with a size of 30 and B with a size of 30. The size of the blocks is 4 and in each block, each intervention group will be repeated twice. 15 blocks of 4 will be produced 15 times to create a total of 60 sequences. 
Group A or intervention group includes patients receiving rose essential oil and group B or comparison group includes patients receiving base oil as a placebo.
To hide the random allocation list, a special code will be assigned to each of the intervention groups that only the principal executor (supervisor) is aware of. These codes are written on a piece of paper and placed in a sealed envelope. A single code specific to each patient will be written on this paper as well as on the envelope. All envelopes are placed in a larger box in random order and will be sealed in the box. The evaluator will not know about the allocation of two groups of rose essential oil and placebo.
Blinding:
  According to the type of intervention, only the primary and secondary outcome assessor is unaware of the type of intervention, and also the data is provided to the statistical expert for statistical analysis in a blind and randomized code.</study_design>
      <phase>3</phase>
      <hc_freetext>Postpartum Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mothers who, after discharge, put a cc of rose  essential oil on a special cloth and put it on their mouth and nose every night before going to bed for 12 weeks after giving birth, using a dropper, and take 10 deep breaths, and then They put the cloth next to their pillow until morning. Intervention 2: Control group: Mothers who, after discharge, put a cc of distilled water on a special cloth  and put it on their mouth and nose every night before going to bed for 12 weeks after giving birth, using a dropper, and take 10 deep breaths, and then They put the cloth next to their pillow until morning.</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:
Evaluation of the effectiveness of aromatherapy with Rosa damascena  Mill. to relieve the symptoms of postpartum depression in primiparus women

When:
7 December 2021

To whom:
Babol University of Medical Sciences research deputy

Conditions:
Postpartum Depression

Where to obtain:
Postpartum ward of hospitals under the auspices of Babol University of Medical Sciences

How to obtain:
Request of the Deputy of Health Research Institute of Babol University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereshteh Behmanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Midwifery and Nursing, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Mazandaran Province</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۷۱۷۶-۴۷۷۴۵</zip>
        <telephone>+98 11 3219 9595</telephone>
        <email>f.behmanesh2015@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fereshteh Behmanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Midwifery and Nursing, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Mazandaran Province</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۷۱۷۶-۴۷۷۴۵</zip>
        <telephone>+98 11 3247 5421</telephone>
        <email>f.behmanesh2015@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be literate
Age 20-35 years
Do not use Drugs and Alcohol
No history of Asthma, Allergies or skin Dermatitis diagnosed
No history of Allergies and Eczema diagnosed to flowers and plants
Lack of known mental disorders
Do not use Anti-stress and Anti-depressant drugs
Having a sense of smell
Get a score below 13 according to the Edinburgh Depression Inventory
The birth of a seemingly healthy baby</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Sensitivity to the oils provided
History of sensitivity to special oils in one of the family members of the subjects</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>000</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Service Temporarily Down</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mothers who, after discharge, put a cc of rose  essential oil on a special cloth and put it on their mouth and nose every night before going to bed for 12 weeks after giving birth, using a dropper, and take 10 deep breaths, and then They put the cloth next to their pillow until morning.</i_keyword>
      <i_keyword>Control group: Mothers who, after discharge, put a cc of distilled water on a special cloth  and put it on their mouth and nose every night before going to bed for 12 weeks after giving birth, using a dropper, and take 10 deep breaths, and then They put the cloth next to their pillow until morning.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in the Edinburgh postpartum depression questionnaire. Timepoint: Determination of depression score in the first 24 hours after delivery  (before intervention), 6 weeks and 12 weeks after starting rose essential oil. Method of measurement: Edinburgh Postpartum Depression questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleep quality score. Timepoint: Determining the quality of sleep in the first 24 hours after delivery (before the intervention), 6 weeks and 12 weeks after starting rose essential oil. 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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-21</approval_date>
        <contact_name>Babol University of Medical Sciences</contact_name>
        <contact_address>Keshavarz- Babol University Of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
