<?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>IRCT20201027049164N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-15</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparison between the effectiveness of auriculotherapy and counseling based on spiritual therapy enhanced by cognitive-behavioral techniques on the pattern of substance usage among women under the supervision of women’s counseling center in Kerman, 2021</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between the effectiveness of auriculotherapy and counseling based on spiritual therapy enhanced by cognitive-behavioral techniques on the pattern of substance usage among women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59436</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The samples will be selected in an available way and then using a simple random method by numbering people from 1 to 105 and entering the numbers into the statistical software (R). With this software, people will be divided into three groups of 35 people. It should be noted that all participants in all three groups will be addicted to drugs and all three groups will use methadone maintenance treatment. 35 people will be assigned from counseling, uriculotherapy and control groups.In the control group, in order to blind, while sticking labels on parts of the ear, the labels were gently touched to prevent any bias and also the researcher will be physically present with the people for 20 minutes but no intervention will be done. There is also blindness for people who do data analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pattern of drug use.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Counseling with a spiritual therapy approach enhanced by the protocol of spiritual therapy Richard and Berlin (2006) in the counseling group at the Women's Counseling Center in Kerman and by a researcher who has previously approved the authority to perform counseling by the relevant specialist. They will find that this number will be divided into 5 groups of 7 people. The consultation will take place in the form of 7 sessions of 90 minutes (once a week) as a group in a quiet place with appropriate lighting. Intervention 2: Intervention group 2: In the uriculotherapy group in the period without menstruation, one session per week (for 3 weeks) and a total of 6 sessions in two months in the points of my sand, nicotine, long point (lung), which includes long 1 and long 2, the thalamic point, sensory point, cerebral point, allergy point and liver point (liver) will be stimulated using a hand probe for 15 seconds and then Seyed Vakaria will be attached to the points. It is recommended to press each point for one minute. Do this every hour for one minute, except at bedtime. Do this for a week. The next week, the sidewalls will be reattached and the steps will be done again. Intervention 3: Control group: There will be no intervention in this 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>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 release schedule is not yet known</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Esmaeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Science,Medical University Campus,Haft-Bagh Highway,Kerman,Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>76169-13555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>fateme.esmaeili1374b@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masumeh Ghazanfarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman University of Medical Science,Medical University Campus,Haft-Bagh Highway,Kerman,Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5856</telephone>
        <email>M.ghazanfarpour@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a female gender
Treated with a methadone maintenance dose
Minimum literacy reading and writing
Having a personal desire and conscious satisfaction to participate in the study
Absence of severe physical illness (absence of severe underlying illness)
Lack of any significant psychiatric disorders of anxiety and depression and significant psychiatric neurological symptoms
Do not use any drugs that affect memory and cognitive function
Believing in Islam
Absence of severe cognitive disorders (Alzheimer's and dementia)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use substances such as methadone to quit addiction at the same time
Absence of more than two sessions in counseling sessions
Having any severe underlying disease
Do not use a methadone maintenance dose
Reluctance to continue participating in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z63.72</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alcoholism and drug addiction in family</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 group 1: Counseling with a spiritual therapy approach enhanced by the protocol of spiritual therapy Richard and Berlin (2006) in the counseling group at the Women's Counseling Center in Kerman and by a researcher who has previously approved the authority to perform counseling by the relevant specialist. They will find that this number will be divided into 5 groups of 7 people. The consultation will take place in the form of 7 sessions of 90 minutes (once a week) as a group in a quiet place with appropriate lighting.</i_keyword>
      <i_keyword>Intervention group 2: In the uriculotherapy group in the period without menstruation, one session per week (for 3 weeks) and a total of 6 sessions in two months in the points of my sand, nicotine, long point (lung), which includes long 1 and long 2, the thalamic point, sensory point, cerebral point, allergy point and liver point (liver) will be stimulated using a hand probe for 15 seconds and then Seyed Vakaria will be attached to the points. It is recommended to press each point for one minute. Do this every hour for one minute, except at bedtime. Do this for a week. The next week, the sidewalls will be reattached and the steps will be done again.</i_keyword>
      <i_keyword>Control group: There will be no intervention in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pattern of drug use. Timepoint: ذeginning of the study (before the intervention) and at the end of the intervention. Method of measurement: Drug use pattern 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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-18</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology.,ebne-e-Sina St.,Jahad Blvd.,Kerman,Iran Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
