<?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>IRCT20170611034452N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-02</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparative investigation between the effectiveness of aromatherapy with Lavandula angustifolia with counselling based on Mindfulness-based Cognitive Therapy for sexuality (MBCT-S) on the sexual function of married women</public_title>
      <acronym></acronym>
      <scientific_title>Comparative investigation between the effectiveness of aromatherapy with Lavandula angustifolia with counselling based on Mindfulness-based Cognitive Therapy for sexuality (MBCT-S) on the sexual function of married women in reproductive age</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55142</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The method of sampling will be simple accident, In this way, the list of women of reproductive age will be obtained through the SIB system and will be contacted randomly. How to randomize using online software to generate random sequences(www.randomizer.org).
To randomize the selection, Participants will be assigned a number from 1 to 60 respectively, Then using the block random allocation method With six blocks of ten, People will be divided into three groups of 20.In order to hide the random allocation process and avoid selective bias ,this action after preparing the final list and will be done by someone other than the principal investigator and the researcher will be obliged to act exactly accordingly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Women with sexual dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:1. Treatment with lavender aroma : Standard lavender essential oil is purchased from Kashan Drug Pharmaceutical Company and after packaging in dark colored glasses containing 10 cc of essential oil is provided to the patient. The aromatherapy group daily pours 2-3 drops of lavender essential oil on a napkin daily and inhales from a distance of 20 cm. Intervention 2: Intervention group2:. Sexual counseling group with mindfulness-based cognitive therapy approach: Participants in 8 sessions of 120 minutes (one session per week) will receive group sexual counseling with mindfulness-based cognitive therapy approach.Counseling will be provided by a trained researcher.The number of participants in each session will be a maximum of ten people in accordance with health protocols.Due to the global prevalence of Covid-19 disease, if the prevalence of this disease is high at the time of intervention, counseling will be done virtually. Intervention 3: Control group: .The third group, as a control group, will not receive any intervention other than the routine interventions of the health center. In order to comply with the ethical principles, all the contents of the counseling sessions will be provided to all members of the control group in the form of an educational booklet after the end of the research, and will be referred to counseling centers or gynecologists to investigate the problem.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Teimori Ghotb</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5205</telephone>
        <email>zahra.teimori66@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefe Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5205</telephone>
        <email>a.ahmadi@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married
Being sexually active
18-45 years old women</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>happening of major stress during 3 months before intervention
smelling disorders before intervention
being pregnant before intervention
Sensitivity to lavender essential oil before intervention
Digestive disorders such as nausea, vomiting, stomachache and nausea before the intervention</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>Treatment - Drugs</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:1. Treatment with lavender aroma : Standard lavender essential oil is purchased from Kashan Drug Pharmaceutical Company and after packaging in dark colored glasses containing 10 cc of essential oil is provided to the patient. The aromatherapy group daily pours 2-3 drops of lavender essential oil on a napkin daily and inhales from a distance of 20 cm.</i_keyword>
      <i_keyword>Intervention group2:. Sexual counseling group with mindfulness-based cognitive therapy approach: Participants in 8 sessions of 120 minutes (one session per week) will receive group sexual counseling with mindfulness-based cognitive therapy approach.Counseling will be provided by a trained researcher.The number of participants in each session will be a maximum of ten people in accordance with health protocols.Due to the global prevalence of Covid-19 disease, if the prevalence of this disease is high at the time of intervention, counseling will be done virtually.</i_keyword>
      <i_keyword>Control group: .The third group, as a control group, will not receive any intervention other than the routine interventions of the health center. In order to comply with the ethical principles, all the contents of the counseling sessions will be provided to all members of the control group in the form of an educational booklet after the end of the research, and will be referred to counseling centers or gynecologists to investigate the problem.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of sexual function. Timepoint: To assess the level of sexual function, in two stages, once before the intervention and once immediately after the intervention, the questionnaire (FSFI) is completed by the participants of all three groups. Method of measurement: Female Sexual Function Index (FSFI)-Questionnaire.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-15</approval_date>
        <contact_name>Ethics Committees of Kerman University Of  Medical Sciences</contact_name>
        <contact_address>Medical Science, Medical University Campus, Haft Bagh Highway Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
