<?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>IRCT20160427027633N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-17</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>comparison of aromatherapy with Citrus aurantium and lavender on sexual satisfaction of lactating women</public_title>
      <acronym></acronym>
      <scientific_title>comparison of aromatherapy with Citrus aurantium and lavender on sexual satisfaction of lactating women referred to health care centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>210</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22595</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, Simple randomization method is used for random allocation (hiding allocation). In this way, 210 cards matched in appearance are prepared and 70 of them have the number or code 1 that specifies the group "Intervention based on essence of Citrus aurantium " and on 70 others of them the number or code 2 which specifies the group "Intervention based on essence of lavender " and on the other 70 Of them, the number or code 3, which specifies the control group, means "routine actions" is written. Then, each eligible person for inclusion in the study randomly takes one of these cards with the codes written on it. In this way, the random allocation of patients to each group is determined without letting the participants to know the nature of the numbers 1, 2, or 3 in the type of intervention that will be assigned, Blinding description: In this study, to hide the allocation of aromas (essence of Citrus aurantiumor lavender) and placebo (Firouz baby oil) Opaque envelopes sequentially numbered are used.Each envelope contains a glass of essence of Citrus aurantiumor lavender or placebo. Medications were placed on the envelope in the randomized allocation sequence by the person not involved in the study. Investigating individuals to study and delivering envelopes are done by the researcher himself from 1 to 210. Therefore, in this study, participant and researcher blindness are used. Blindness of data analyzer also runs. Thus, individuals in two groups of intervention (Citrus aurantium or lavender) and the placebo group (Firouz babyoil) are characterized by code (for example, codes 1, 2 and 3) and data analyzer is not aware of the subject code. So the study is triple-blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sexual satisfaction.</hc_freetext>
      <i_freetext>Intervention 1: Interventions 1: intervention with Lavender aroma: They received three times a day and each time, 2 to 3 drops of solution are injected into the forearm area of the hand for 40 days in an inhaler. Intervention 2: Interventions 2: intervention with Citrus aurantium aroma: They received three times a day and each time, 2 to 3 drops of solution are injected into the forearm area of the hand for 40 days in an inhaler. Intervention 3: Intervention 3:control  with  Firuze baby oil aroma: They received three times a day and each time, 2 to 3 drops of solution are injected into the forearm area of the hand for 40 days in an inhaler.</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></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Foruzan Sharifipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dolat Abad, Isar Square</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3828 2101</telephone>
        <email>sharifipour_fr91@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Susan heydarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dolat Abad, Isar Square</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3828 2101</telephone>
        <email>s.heydarpour1394@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>willingness to participate in the study
having health dossier in health care centers
literacy sufficient to complete of the questionnaire
married and lives with her husband permanently
use a reliable method of contraception
exposure during lactation (6-3 months postpartum)
lack of mental health problems or known systemic disease affecting a person's sexual function
lack of drug dependence
lack of sexual problems in husband according wife's comment
lack of addicted husband
the absence of stressful events in the last 6 months (divorce of parents, death of family members, etc.)
the absence of diseases, , lack of stress factors (Parent divorce in the past six months), l
the lack of any effective drug on a person's sexual response (Antihypertensive drugs, Thiazide Diuretics, Antidepressants, Antihistamines, Barbiturates, Narcotics, Diazepins, Amphetamines, Cocaine)
lack of disorder of olfactory or sensitivity to herbal medicines according wife's comment and other disorders related to nose (fracture, deviated septum, rhinitis and sinusitis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>dissuasion of participating in the study
incidence of side effects and sensitivity to essential oils during the study
emotional major event such as a death of One of the relatives in particular loss of child
proof of pregnancy occurrence during the study
the incidence of mental health problems or serious illness during the study
living away from his husband
catching the debilitating diseases such as cancer that person will have to leave the study
surgery during the intervention
divorce,death or illness of husband during the intervening period of study</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions 1: intervention with Lavender aroma: They received three times a day and each time, 2 to 3 drops of solution are injected into the forearm area of the hand for 40 days in an inhaler.</i_keyword>
      <i_keyword>Interventions 2: intervention with Citrus aurantium aroma: They received three times a day and each time, 2 to 3 drops of solution are injected into the forearm area of the hand for 40 days in an inhaler.</i_keyword>
      <i_keyword>Intervention 3:control  with  Firuze baby oil aroma: They received three times a day and each time, 2 to 3 drops of solution are injected into the forearm area of the hand for 40 days in an inhaler.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual satisfaction. Timepoint: Before and 40 days after the intervention. Method of measurement: Lindaberg's Sexual Satisfaction Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects. Timepoint: 40 days after start the intervention. Method of measurement: Researcher made questionnaire.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-19</approval_date>
        <contact_name>Ethics committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti Avenue, Research Deputy of Kermanshah University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
