<?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>IRCT20210814052180N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-07</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of foot reflexology on sexual function in lactating mothers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of foot reflexology on sexual function in lactating mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58477</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants are divided into control and intervention groups based on a simple random allocation method. To randomize, the researcher has two types of cards in a large envelope, one of which has the word “control” written on it and the other the word “intervention”, then Participants are asked to take out one of them without looking at the cards in the envelope, and thus will be placed in the intervention or control group based on the selected card.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sexual function in lactating mothers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, an educational pamphlet about sexual function after birth is presented and a female sexual function index questionnaire is completed, then 10 sessions of foot reflexology are performed for each person in this group. Each intervention session takes 50 minutes, with 25 minutes for each foot (20 minutes of general reflexology and 5 minutes of specific reflexology). The intervention is performed twice a week with an interval of 2 to 3 days and a total of 10 sessions and then 4 weeks later the female sexual function index questionnaire is completed. Intervention 2: Control group: First, an educational pamphlet about sexual function after birth is presented and the female sexual function index questionnaire is completed, then the people receive routine care at health centers and after 9 weeks, the female sexual function index questionnaire is completed again.</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>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Ghanbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 11, Alley 32, Imam Hossein St.</address>
        <city>Golpayegan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8771645189</zip>
        <telephone>+98 31 5742 5103</telephone>
        <email>zahra.ghanbari@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahnaz Kohan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences., Hezar Jarib St</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7545</telephone>
        <email>kohan@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>lactating Women within 40 days to 5 months after delivery
Be literate
Having Iranian citizenship
Obtaining a score higher than zero from the Female sexual function index questionnaire</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Existence of known  sexual problems which affecting sexual function in women or their husbands, such as premature ejaculation and impotence in the husband, or vaginismus and dyspepsia in women (determined by asking participants and reviewing their file)
Having known chronic diseases in these women or their husbands that affect sexual function such as mental illness (schizophrenia), mood disorders (depression), ulcerative colitis, vasculitis, thyroid, and adrenal cortex diseases, diabetes, Blood pressure, heart, lung, liver, kidney diseases, central nervous system disorders, infectious and sexually transmitted infections (determined by asking participants and reviewing their file)
Use of drugs affecting sexual function in women or their spouses, including psychotropic drugs, cardiac and anti-hypertensive drugs, thiazide diuretics, anticonvulsant drugs, H2 receptor blockers, opioids, anticholinergics, antihistamines, Antidepressants, and sleeping pills
Alcohol, cigarette and drug addiction in women or their husbands
use of other types of complementary and alternative medicine methods affecting sexual function such as acupuncture, auricular therapy, and massage therapy
Presence of deformity, calluses, fissures or ulcers of the foot, active thrombosis or phlebitis, varicose veins, history of recent ankle trauma, sprains and fractures, infection or inflammation of the soles of the feet</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 - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First, an educational pamphlet about sexual function after birth is presented and a female sexual function index questionnaire is completed, then 10 sessions of foot reflexology are performed for each person in this group. Each intervention session takes 50 minutes, with 25 minutes for each foot (20 minutes of general reflexology and 5 minutes of specific reflexology). The intervention is performed twice a week with an interval of 2 to 3 days and a total of 10 sessions and then 4 weeks later the female sexual function index questionnaire is completed.</i_keyword>
      <i_keyword>Control group: First, an educational pamphlet about sexual function after birth is presented and the female sexual function index questionnaire is completed, then the people receive routine care at health centers and after 9 weeks, the female sexual function index questionnaire is completed again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual function score of lactating women in Women's Sexual function Index (FSFI) questionnaire. Timepoint: Evaluation of sexual function score before the intervention and then four weeks after the intervention. Method of measurement: Female Sexual function Index Questionnaire (FSFI).</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-26</approval_date>
        <contact_name>Ethics committee of Isfahan University of medical Sciences</contact_name>
        <contact_address>Building No. 4 - Vice Chancellor for Research and Technology, Hezar Jerib St., Isfahan University of Medical Sciences and Health Services., Isfahan Town Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
