<?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>IRCT20190626044028N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-16</date_registration>
      <primary_sponsor>Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Auricular Acupressure on Lactating Women’s Sexual Function</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Auricular Acupressure on Lactating Women’s Sexual Function</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40525</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: participants will be randomized into two groups by the Simple Random Blocking method with 4 blocks.In the block randomization method, the assigning sequence will be written before the commencement of the research. Given that two groups will be studied, four blocks will be used and one letter will be assigned to one group (A: EMDR group; B: control group). All possible modes of the 4 blocks will be written and numbered. So, in each block, two participants will be assigned to the intervention group and two will be assigned to the control group. Then, using a simple random method and the table of random numbers, a number of blocks will be selected from the blocks of numbers. By writing the contents of the blocks for those numbers (as long as the sample size is determined), the sequence of random allocation is determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual Dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: acupressure group: The trained researcher first cleaned both auricle with 75% alcohol and then sticks the vaccaria seeds with non-latex adhesives tape on the 5th point of the ear (genital points (two points), Pelvic point, Master Soulder and posterior hypophysis) that affects the sexual function of the person. A total of 10 sessions are held at intervals of four days per person. During these sessions, the seeds are stuck on the points and the subject is trained to hold the seeds for three days on her ear and during this time she should press each of the points three times a day for twenty Seconds. The pressure technique should be such that the person performs a moderate instillation by pressing firmly and a little tighter, until she feels a tingling and mild discomfort. After three days, the person can remove the seeds from her ear and rest one day. The number of pressing will be reminded to the subject via SMS daily. she will also be reminded by phone call that the fifth day will be referred to the center for resticking the new vaccaria seeds. This procedure takes place in ten sessions for each subject. It should be noted that if the subject experienced any problem during the use of the method for any reason (the movement of seeds, removing them, etc.) could separate the previous seeds and request the researcher to restick the new seeds again. Intervention 2: Control group: Receive Counseling and routine care.</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:
Information about the original outcome is shared

When:
Start of the 6 month period after the publication of the study results

To whom:
All researchers in the field of health sciences and medicine can apply for data.

Conditions:
A new analysis of data can be done only by explaining the reasons for the request for such an analysis and with the knowledge of the researcher

Where to obtain:
To receive the data, you can contact the person responsible for this clinical practice (Sanaz Borgamadi) by e-mail s.barghamadi@qums.ac.ir.

How to obtain:
fter receiving the application for having a data file and obtaining permission from the university Research Deputy, the data file is shared.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sanaz Barghamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin university of medical science, Bahonar Blvd., Qazvin Town</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>34199-15315</zip>
        <telephone>+98 21 7713 4704</telephone>
        <email>s.barghamadi@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sanaz Barghamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qazvin university of medical science, Bahonar Blvd., Qazvin Town</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>34199-15315</zip>
        <telephone>+98 21 7713 4704</telephone>
        <email>s.barghamadi@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The Desire to Participate in the Study
Being Primipara
Having Lactation
Having term and singleton Baby
Being in the First Year after Childbirth
Having a Natural Auricle Without Lesion, Wounds and Pain on the Auricle
Being Iranian
Ability to read and write
Availability During the Study Period</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Being Away from the Spouse
Polygamous Husband
Complications in Pregnancy and Postpartum
The History of Mental and Physical Illness (Self-Declaration and Examination of a Person's Health Record)
Postpartum Depression detected by the Edinburgh Postnatal Depression Scale
Substance Abuse in the Person or her Husband
A History of Using Acupressure in the Last Three Months
A History of Diseases Affecting the Sexual Function of a Woman or her Husband such as Premature Ejaculation, Cardiovascular, Psychiatric, Thyroid Disease and All Types of Cancers and Genital Trauma
Use of Drugs That Affect Sexual Function Such as Psychoactive, Cardiovascular, Nervous and Hormonal Drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sexual dysfunction not due to a substance or known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: acupressure group: The trained researcher first cleaned both auricle with 75% alcohol and then sticks the vaccaria seeds with non-latex adhesives tape on the 5th point of the ear (genital points (two points), Pelvic point, Master Soulder and posterior hypophysis) that affects the sexual function of the person. A total of 10 sessions are held at intervals of four days per person. During these sessions, the seeds are stuck on the points and the subject is trained to hold the seeds for three days on her ear and during this time she should press each of the points three times a day for twenty Seconds. The pressure technique should be such that the person performs a moderate instillation by pressing firmly and a little tighter, until she feels a tingling and mild discomfort. After three days, the person can remove the seeds from her ear and rest one day. The number of pressing will be reminded to the subject via SMS daily. she will also be reminded by phone call that the fifth day will be referred to the center for resticking the new vaccaria seeds. This procedure takes place in ten sessions for each subject. It should be noted that if the subject experienced any problem during the use of the method for any reason (the movement of seeds, removing them, etc.) could separate the previous seeds and request the researcher to restick the new seeds again.</i_keyword>
      <i_keyword>Control group: Receive Counseling and routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual Function. Timepoint: Sexual Function Measurement at the beginning of the study (before intervention) ,immidiate, 1 and 2 months after intervention. Method of measurement: Sexual Function Score in Female Sexual Function Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual quality of life. Timepoint: before, 1 and 2 month after intervention. Method of measurement: 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>Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-26</approval_date>
        <contact_name>Ethics committee of Qazvin University of Medical Sciences</contact_name>
        <contact_address>Qazvin university of medical science, Bahonar Blvd., Qazvin Town Qazvin Qazvin Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
