<?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>IRCT2017043033717N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-25</date_registration>
      <primary_sponsor>Vice Chancellor for research of Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Ear acupressure effect on anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effect of auriculotherapy with electrical stimulation and seeds pressure on anxiety before colposcopy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25931</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Auriculotherapy with electrical stimulation, After the above acupoints sterilize with 70% alcohol, the researcher, will be applied Transcutaneous auricular stimulation (TAS) at 4 acupoints (Shenmen, Relaxation, Tranquilizer and Endocrine) with the Pointer Excel II and 2Hz frequency, for 30 seconds on each acupoint. The electrical stimulation will conducted in 40 min before colposcopy on the two ears. Intervention 2: Intervention group2:  Auriculotherapy with seeds, After the above acupoints sterilize with 70% alcohol, the researcher will attach the vaccariae seeds in place by a piece of opaque adhesive patch and fixed on to the 4 acupoint (Shenmen, relaxation, Tranqulizder, endocrine). The subjects will asked to press each point 60 seconds for three times a day (10:00, 16:00, 22:00 respectively), by themselves. The strength should make the local auricle, flushed and ache. The auriculotherapy will conducted in the external ear on the non‌ dominant side, for three days before doing colposcopy until colposcopy day. Intervention 3: Control group:  Researcher will be attached opaque adhesive patch without seed, at 4 non related points to anxiety (Finger, Shoulder, Tonsil and Stomach) without any compression, three days before colposcopy until colposcopy day.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samaneh Jouya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebnesina Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 51 3761 8946</telephone>
        <email>Jouyas941@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Golmakani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebnesina Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Golmakanin@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria include: Patient's consent to participate in this study; Have minimum level of literacy; Haven’t Problems with speech, hearing or mental barrier to communicate with the investigator; Age over 18 years; Not being pregnant or lactating; Do colposcopy for the first time; Lack of addiction to drugs and alcohol, psychological and severe medical  disease; Without  history of auriculotherapy treatment in the last 6 month; Absence of wound or lesion at the ears; Having vital signs within normal limits; Absence of unusual sensitivity in touch ear; Having Stressful accident in the last 3 months. Exclusion criteria are: Using certain drug; Unwillingness to continue cooperation; creating stressful events during the study; Itching or inflammation and infection and removing seed more than 24‌h in the intervention group Seeds.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized Anxiety Disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Auriculotherapy with electrical stimulation, After the above acupoints sterilize with 70% alcohol, the researcher, will be applied Transcutaneous auricular stimulation (TAS) at 4 acupoints (Shenmen, Relaxation, Tranquilizer and Endocrine) with the Pointer Excel II and 2Hz frequency, for 30 seconds on each acupoint. The electrical stimulation will conducted in 40 min before colposcopy on the two ears.</i_keyword>
      <i_keyword>Intervention group2:  Auriculotherapy with seeds, After the above acupoints sterilize with 70% alcohol, the researcher will attach the vaccariae seeds in place by a piece of opaque adhesive patch and fixed on to the 4 acupoint (Shenmen, relaxation, Tranqulizder, endocrine). The subjects will asked to press each point 60 seconds for three times a day (10:00, 16:00, 22:00 respectively), by themselves. The strength should make the local auricle, flushed and ache. The auriculotherapy will conducted in the external ear on the non‌ dominant side, for three days before doing colposcopy until colposcopy day.</i_keyword>
      <i_keyword>Control group:  Researcher will be attached opaque adhesive patch without seed, at 4 non related points to anxiety (Finger, Shoulder, Tonsil and Stomach) without any compression, three days before colposcopy until colposcopy day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before intervention: 3day before colposcopy and 40 minut before colposcopy and after intervention:immediately before colposcopy. Method of measurement: Eshpilberger Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Immediately after colposcopy. Method of measurement: Pain visual analog scale.</sec_outcome>
      <sec_outcome>Estress. Timepoint: In 4 times: 3day before colposcopy, 40 minut before colposcopy, immediately before colposcopy and immediately after colposcopy. Method of measurement: Estress visual analoge scale.</sec_outcome>
      <sec_outcome>Attitude to colposcopy. Timepoint: 40 minute before cplposcopy. Method of measurement: Question.</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>Vice Chancellor for research of Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-12</approval_date>
        <contact_name>Ethics committee of Mashhad Univercity of Medical Sciences</contact_name>
        <contact_address>Ghoreshi building-Daneshgah street Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
