<?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>IRCT20230313057700N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-13</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparative  investigation  between the effect of aromatherapy with Rosa damascena Mill. and Mindfulness-Based Stress Reduction (MBSR) on gestational hypertension in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>Comparative  investigation  between the effect of aromatherapy with Rosa damascena Mill. and Mindfulness-Based Stress Reduction (MBSR) on gestational hypertension in pregnant women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69287</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple randomization according to the numbered list by the computer system, they are divided into two intervention groups and one control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Gestational hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First- the group treated with Rosa damascena aromatherapy - which is treated with 40% Rosa damascena essential oil from Barich Essential Oil Company, inhaled twice a day for 8 weeks. Intervention 2: Intervention group: Second - undergoing treatment with mindfulness-based stress reduction counseling -In 8 sessions of 90 minutes face-to-face and group sessions twice a week, mindfulness-based stress reduction counseling is given. Intervention 3: Control group: It does not receive any intervention.</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:
Only part of the information related to the main outcome is shared

When:
Access starts 6 months after results are published

To whom:
Academic and scientific institutions

Conditions:
It is allowed to use in order to expand the science of mindfulness. The condition of sending the application is to have a university affiliation.

Where to obtain:
Email to the corresponding author, Masoumeh Ghazanfarpour, Address: Midwifery Research Center, Razi School of Midwifery Nursing, Kerman University of Medical Sciences, Iran. Email: masoumeh.ghazanfarpour@yahoo.com Contact number: 00989136330656

How to obtain:
The email requesting data to Mrs. Masoumeh Ghazanfarpour, the responsible author, will be answered after two weeks after going through the administrative process and confirming the identity of the author of the email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoume Ghazanfarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of University of Medical Sciences, first axis of the Haft Bagh Alavi, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3231 0057</telephone>
        <email>masoumeh.ghazanfarpour@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoume Ghazanfarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of University of Medical Sciences, first axis of the Haft Bagh Alavi, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3231 0057</telephone>
        <email>masoumeh.ghazanfarpour@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian race
Age 18 to 40
Being literate
Singleton pregnancy
The first visit before the 16th week of pregnancy
Systolic blood pressure more than 14 and diastolic blood pressure more than 9
The number of pregnancies is 4 or less
Healthy sense of smell</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of high blood pressure before the current pregnancy or in the first 20 weeks (80/130 or more)
Suffering from pre-eclampsia and eclampsia in previous pregnancies
Taking psychiatric drugs
Suffering from anxiety and depression
Allergy to Rosa damascena essential oil or history of allergies and respiratory diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O13</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gestational [pregnancy-induced] hypertension without significant proteinuria</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First- the group treated with Rosa damascena aromatherapy - which is treated with 40% Rosa damascena essential oil from Barich Essential Oil Company, inhaled twice a day for 8 weeks.</i_keyword>
      <i_keyword>Intervention group: Second - undergoing treatment with mindfulness-based stress reduction counseling -In 8 sessions of 90 minutes face-to-face and group sessions twice a week, mindfulness-based stress reduction counseling is given.</i_keyword>
      <i_keyword>Control group: It does not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: At the beginning of the intervention - twice a week during the intervention - immediately after the end of the intervention. Method of measurement: Mercury sphygmomanometer model ALPK2 made in Japan.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: At the beginning of the intervention - twice a week during the intervention - immediately after the end of the intervention. Method of measurement: Mercury sphygmomanometer model ALPK2 made in Japan.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: Before the start of the intervention - immediately after the end of the intervention. Method of measurement: Questionnaire DASS-21.</sec_outcome>
      <sec_outcome>Depression. Timepoint: Before the start of the intervention - immediately after the end of the intervention. Method of measurement: Questionnaire 21-DASS.</sec_outcome>
      <sec_outcome>Stress. Timepoint: Before the start of the intervention - immediately after the end of the intervention. Method of measurement: Questionnaire 21-DASS.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-28</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Campus of University of Medical Sciences, first axis of the Haft Bagh Alavi, Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
