<?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>IRCT20160731029134N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-11</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of auricular acupressure on the quality of life of postmenopausal women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of auricular acupressure on the quality of life of postmenopausal women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36578</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The eligible patients are selected using convenience sampling method and then, using random numbers table, samples will be divided into three groups A, B and C, Blinding description: Variables are measured by the assessor (a trained midwife) who is blind to blind intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Menopausal symptoms.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: in the auricular acupressure group (AG), participants received ear adhesive tape with seed, on the ear sympathetic (AH6a), shenmen (TF4), adrenal gland (TG2p), subcortex (AT4), endocrine (CO18), kidney (CO10), heart (CO15) and liver (CO12) points for both ears.The patients were asked to press the acupoints by themselves four times a day for a 20 second duration each time for four week.It was explainedthat the strength of the pressing should make the local auriclecongestive, flushed, hot and achy. Intervention 2: Control group:  In one control group , participants received ear adhesive tape without seed, on the ear sympathetic (AH6a), shenmen (TF4), adrenal gland (TG2p), subcortex (AT4), endocrine (CO18), kidney (CO10), heart (CO15) and liver (CO12) points for both ears.We note control group not to touch the adhesive.To use the potential psychological effects of adhesive, people are said these adhesives can improve symptoms. Intervention 3: Control group: routine care includes self-care, including doing exercise and walking, diet (such as dairy consumption, a diet containing soy, no spices) and calcium supplementation and vitamin D, exposure to sunlight wearing appropriate cotton clothing, deep breathing during flushing, avoid being near-smoker, do not smoke, recommendations to lie down, or sit on a chair and tilted her head back in the time of flushing, activities to improve sleep, such as shower before bed, eat 1 cup of warm milk, no tea and coffee at the end of the night, ointment lubricant to reduce vaginal dryness during intercourse, it is recommended to maintain sexual relations regularly, activities to reduce anxiety such as doing yoga, and socially active.</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 The research is in progress</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Hadizadeh-talasaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibnsina street -Crossroads Doctora-Danesgah street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00989137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Hadizadehz941@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboubeh Firouzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Ibn Sina street,Danesgah Street ,Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00989137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Firouzim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient's willingness to participate in this study
Residence in Mashhad
Having an age between 45-60
Non-use of tobacco
Non-menstruation at least 12 months ago
natural Menopause
Women who have any of the physical and psychological symptoms such as flushing, sweating, sleeplessness, anxiety, depression, etc
Menopause is less than 10 years
No history of surgery on the ovary
No current use of any herbal medicine
Not receiving hormonal and non-hormonal drugs in the last 6 months to reduce menopausal complications
No history of cardiovascular disease in the past 6 months
Not having thyroid disease
Not having a history of abnormal vaginal bleeding
Not using other complementary therapies</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue cooperation
Doing Acupressure less than twice a week</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N95.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Menopausal and female climacteric states</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: in the auricular acupressure group (AG), participants received ear adhesive tape with seed, on the ear sympathetic (AH6a), shenmen (TF4), adrenal gland (TG2p), subcortex (AT4), endocrine (CO18), kidney (CO10), heart (CO15) and liver (CO12) points for both ears.The patients were asked to press the acupoints by themselves four times a day for a 20 second duration each time for four week.It was explainedthat the strength of the pressing should make the local auriclecongestive, flushed, hot and achy.</i_keyword>
      <i_keyword>Control group:  In one control group , participants received ear adhesive tape without seed, on the ear sympathetic (AH6a), shenmen (TF4), adrenal gland (TG2p), subcortex (AT4), endocrine (CO18), kidney (CO10), heart (CO15) and liver (CO12) points for both ears.We note control group not to touch the adhesive.To use the potential psychological effects of adhesive, people are said these adhesives can improve symptoms.</i_keyword>
      <i_keyword>Control group: routine care includes self-care, including doing exercise and walking, diet (such as dairy consumption, a diet containing soy, no spices) and calcium supplementation and vitamin D, exposure to sunlight wearing appropriate cotton clothing, deep breathing during flushing, avoid being near-smoker, do not smoke, recommendations to lie down, or sit on a chair and tilted her head back in the time of flushing, activities to improve sleep, such as shower before bed, eat 1 cup of warm milk, no tea and coffee at the end of the night, ointment lubricant to reduce vaginal dryness during intercourse, it is recommended to maintain sexual relations regularly, activities to reduce anxiety such as doing yoga, and socially active.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The quality of life for menopause, which in fact measures the annoying symptoms of this period.Determining the Four Dimensions of Quality of Life in Postmenopausal Women (Vasomotor, Psychosocial, Physical and Sexual). Timepoint: At the beginning of the study and after four weeks. Method of measurement: Menopause-Specific Quality of Life Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Signs and common complications of menopause including duration and severity of daily hot flashes. Timepoint: Daily. Method of measurement: Daily hot flash recording form.</sec_outcome>
      <sec_outcome>Sleep status. Timepoint: At the beginning of the study and after four weeks. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: At the beginning of the study and after four weeks. Method of measurement: Hamilton Anxiety Rating Scale.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-06</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Avenue next to the cinema Hoveizeh- Mashhad Medical Sciences, Ghoreishi building Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
