<?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>IRCT20191130045549N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-03</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>investigation of The effectiveness of auriculotherapy on sexual function of women of reproductive age</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of The effectiveness of auriculotherapy on sexual function of women of reproductive age to comprehensive health centers in Baft city at the year 1399-1400</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62494</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: no, Randomization description: 60 women of childbearing age will be selected easily (available) and for random allocation, 4 and 8 blocks with a 1: 1 allocation ratio will be used. After listing almost all possible modes of blocks 4 and 8 and assigning a number to each of them using the site www.Randomizer.org will be selected as an allocation sequence, so that the total number of samples is 60 People became. Then, to hide the Allocation Concealment, the type of intervention numbered on the first 30 cards of number 1, the second 30 cards of number 2, will be written on paper and placed in a series of sealed envelopes. Number 1 of the auricular therapy group will be number 2 of the control group, Blinding description: Participants will be placed in the Syed intervention group and small adhesives without Vacaria will be placed in the control group.
Outcome assessors and data analysts have no knowledge of intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sexual function.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Auriculotherapy group in ten sessions for 20 minutes using Vacaria plant seeds and handmade props made in China for erectile dysfunction and decreased libido from the left ear points including sexual dysfunction, genitalia, gonadotropin, ovary, zero point, Shen Man, endocrine Mr. Cerebral, anxiety point, thalamic, excessive libido on the right ear, sexual complicity, irritability point, excitement point, ovary, zero point, my sand, tranquilizer point, thalamic are stimulated. The seeds should be taken every hour during the day. Stimulated for one minute by the patient for three days. Intervention 2: Control group: They massage parts of the ear with their hands.</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:
All data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
Data will be provided to all applicants.

Conditions:
Any kind of analysis on the data is allowed.

Where to obtain:
Through the following email, which belongs to Dr. Masoumeh Ghazanfarpour:masumeh.ghazanfarpour@yahoo.com

How to obtain:
Through correspondence and e-mail with Dr. Masoumeh Ghazanfarpour and if 6 months have passed since the publication of the results.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Masoumeh Ghazanfarpour</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 5219</telephone>
        <email>masumeh.ghazanfarpour@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Masoumeh Ghazanfarpour</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 5219</telephone>
        <email>masumeh.ghazanfarpour@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ages 18 to 45
be sexually active
have no history of physical or mental illness or depression
have no history of antidepressant use, sedatives
no infection or scarring on the outer ear
have a minimum of literacy and numeracy
Have at least one healthy ear
have at least one sexual problem
no vaginal or cervical infection</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lack of patient cooperation on pressing the inserted sidewalls
Severe marital conflicts
The occurrence of a tragic event (death of loved ones, etc.)</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 - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Auriculotherapy group in ten sessions for 20 minutes using Vacaria plant seeds and handmade props made in China for erectile dysfunction and decreased libido from the left ear points including sexual dysfunction, genitalia, gonadotropin, ovary, zero point, Shen Man, endocrine Mr. Cerebral, anxiety point, thalamic, excessive libido on the right ear, sexual complicity, irritability point, excitement point, ovary, zero point, my sand, tranquilizer point, thalamic are stimulated. The seeds should be taken every hour during the day. Stimulated for one minute by the patient for three days.</i_keyword>
      <i_keyword>Control group: They massage parts of the ear with their hands</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score of sexual function disorders in the sexual function questionnaire. Timepoint: Measurement of sexual function disorders before and after the intervention. Method of measurement: Female  Sexual Function questionnaire.</prim_outcome>
      <prim_outcome>Sexual satisfaction score in Larson's sexual satisfaction questionnaire. Timepoint: Measuring the sexual satisfaction of the patient and the patient's wife before and after the intervention. Method of measurement: Larson sexual satisfaction 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>2021-06-01</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
