<?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>IRCT20211129053224N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-09</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Auriculotherapy on stress and anxiety of abortion</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Auriculotherapy on stress and anxiety of legal abortion</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60410</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: . In this study, the permutation block method will be used to generate a sequence of random allocation of individuals to the study groups. Random allocation sequences will be performed using random allocation software and block size two. The permutation block method is one of the random allocation methods in which each block is selected according to the number of groups studied. In this study, there are two blocks, AB and BA. One of the blocks is randomly selected. If the first block, AB, is selected, the first person is assigned to group A and the second person to group B, and this process continues until all samples are allocated. The characteristic of this method is that the two study groups will have equal numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Stress. Condition 2: Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: After selecting each research unit, the demographic information questionnaire, Spielberger anxiety questionnaire and stress questionnaire (DASS-21) for both intervention and control groups will be completed by the researcher. Selected areas: My Sand / Heart / and Uterus (3 areas in total) are on both ears. The duration of applying pressure on each point is 30 seconds, a total of 3 minutes and the amount of pressure is 1 kg. Massage time: (The first massage with the applicator one hour before the start of treatment with misoprostol and the second massage with the applicator one hour after the start of treatment with misoprostol) There are 2 massages with the applicator. One hour before and after the first round of echocardiography with the applicator, the Spielberger Manifest Obvious Anxiety and Stress Questionnaire (DASS-21) will be completed. Then, one hour after starting the treatment with misoprostol, the second round of auricular therapy with the applicator will be performed by the researcher. Also, one hour before and one hour after the second round of uriculotherapy, the Spielberger Anxiety and Stress Questionnaire (DASS-21) will be filled out by the researcher. Intervention 2: Control group: Routine care is performed in the control group.</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:
The data will be shared after it becomes unidentifiable

When:
All researchers

To whom:
All researchers

Conditions:
All women have an abortion license from a forensic center

Where to obtain:
Email ghomioa982@mums.ac.ir Library of Mashhad School of Nursing to Mashhad, Daneshgah St.

How to obtain:
First, send a requested email and if you do not respond within a week, you can refer to the library of Mashhad School of Nursing.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahin Tafazzoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University St., School of Nursing - Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Tafazzolim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Tafazzoli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University St., School of Nursing - Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Tafazzolim@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-35 years
Minimum literacy Gestational
age less than 19 weeks
Willingness to participate in research and to have conscious satisfaction
Low risk pregnancies
Body mass index between 18.5 and 30
No history of treatment with Auriculotherapy during the last 6 months
No sores or any lesions on the ear
Contraindicated in Auriculotherapy Do not have a specific mental illness
.Do not have severe medical disorders
.No sores or any lesions (purulent papules, moles, skin inflammation) on the ear
Do not have a history of taking certain medications.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Dissatisfaction and cooperate
Emergency of the patient due to bleeding and going to the operating room before the intervention
Disposal of products before the end of the intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.0</hc_code>
      <hc_code>F41.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute stress reaction</hc_keyword>
      <hc_keyword>Anxiety disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After selecting each research unit, the demographic information questionnaire, Spielberger anxiety questionnaire and stress questionnaire (DASS-21) for both intervention and control groups will be completed by the researcher. Selected areas: My Sand / Heart / and Uterus (3 areas in total) are on both ears. The duration of applying pressure on each point is 30 seconds, a total of 3 minutes and the amount of pressure is 1 kg. Massage time: (The first massage with the applicator one hour before the start of treatment with misoprostol and the second massage with the applicator one hour after the start of treatment with misoprostol) There are 2 massages with the applicator. One hour before and after the first round of echocardiography with the applicator, the Spielberger Manifest Obvious Anxiety and Stress Questionnaire (DASS-21) will be completed. Then, one hour after starting the treatment with misoprostol, the second round of auricular therapy with the applicator will be performed by the researcher. Also, one hour before and one hour after the second round of uriculotherapy, the Spielberger Anxiety and Stress Questionnaire (DASS-21) will be filled out by the researcher.</i_keyword>
      <i_keyword>Control group: Routine care is performed in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress score. Timepoint: One hour before the first intervention, one hour after the first intervention, one hour before the second intervention and one hour after the second intervention. Method of measurement: Stress Questionnaire (DASS-21).</prim_outcome>
      <prim_outcome>Anxiety score. Timepoint: One hour before the first intervention, one hour after the first intervention, one hour before the second intervention and one hour after the second intervention. Method of measurement: Spielberger Anxiety 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-02</approval_date>
        <contact_name>Ethics Committee of the School of Nursing and Midwifery, Mashhad University of Medical Sciences</contact_name>
        <contact_address>Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Crossroads, Ibn Sina St., School of Nursing and Midwifery Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
