<?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>IRCT20240429061588N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-01</date_registration>
      <primary_sponsor>Pardis International University</primary_sponsor>
      <public_title>The effect of virtual reality in the treatment of addiction</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of aversive therapy using virtual reality on drug craving, depression and self-efficacy in patients under methadone maintenance treatment `</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>99</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76498</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After the purposeful selection of samples, the randomization of the division of groups is done using Random allocation software and based on the table of random numbers. Also, the website (https://www.sealedenvelope.com) is a useful site for generating a random sequence for randomization of It is a block type; And it will be comparable.</study_design>
      <phase>3</phase>
      <hc_freetext>Substance Use disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 33 study intervention participants are justified for a period of 12 weeks not to change their normal physical and nutritional activities during this period of study. Patients are evaluated once a week by a free urine addiction test and the patients' non-slip test by a trained expert. is controlled.This intervention can be done with virtual reality glasses. Therefore, its tools are a three-dimensional display similar to the combination of large glasses with a hat. There are two very small monitors in it that cover a wide field of viewThe visualization for this intervention in this software is not adapted and has an atmosphere that reminds of the conditions for consuming morphine, heroin, or hashish, and is covered with old clothes and sitting and messy dishes that create a feeling of numbness and discomfort. It induces the person and the possibility and conditions of abstinence and staying away from substances are embedded in it.The main character who is a patient of addiction, by choosing the right and folding clothes, arranging the room, has a clean house, he knows that he has done abstinence, and also by destroying the tools of use, he adds to the score of the user, if the patient is towards drug use and touching the tools with the intention of use. Broad misses the chance to score from it. And the troubling images of Trustak will also see the condition of a patient with severe addiction and its side effects, which is disgusting and will receive strange and scary sounds . Intervention 2: Intervention group: The second intervention: 33 addiction patients who receive psychological counseling during the study period, the discussions are conducted by a counselor. The psychological counselor is a senior psychology expert who has completed MMT methadone therapy, CBT and schema therapy. Intervention 3: Intervention group: Intervention group: Third intervention: 33 patients using methadone with a routine dose in maintenance treatment are subjected to methadone intervention.</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:
All materials related to the research and documents that can be published in the form of a full article will be published in the open ACCESS journal, only the names of the participants in the research will be avoided.

When:
Information and processing will be available in magazines from January 2025

To whom:
All people interested in the science of addiction and virtual reality

Conditions:
This study can be used with the aim of preventing the waste of time and money resources on addiction treatment and virtual reality and metaverse projects that are not yet complete or have not been completed. During the pilot implementation of this plan, the shortcomings and problems in the implementation are identified and investigated so that the next study plan can be completed. The pilot of this study is a very good option to evaluate the performance of the system, because this type of study can be implemented at a faster rate and at a lower cost in the future.

Where to obtain:
Contact the Correspondents via email

How to obtain:
The request is sent to the responsible author via e-mail. After consulting with the professor or the first person of the article, the author provides the authorized data

Comments:
Hoping to prevent and treat addiction</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Sadat Ghoreishi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kargarnejad Hospital ,Ghotb ravandi BLv.Kashan Town</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973446</zip>
        <telephone>+98 31 5558 9212</telephone>
        <email>z.ghoreishi@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Nasim Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No30,Ahmadi Sakha Ave, Ghazvin Ave,TEHRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1337875761</zip>
        <telephone>+98 21 2237 9431</telephone>
        <email>drsadeghi6@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Clients should visit the clinic at least once a week
Age 25 to 55 years
Clients are on a fixed dose of methadone maintenance treatment for at least 3 months or more
Clients are willing to participate in the project and complete the treatment consent form
Have at least reading and writing literacy
Have the ability to speak and communicate
Absence of severe vision and hearing problems
Absence of severe and frequent headaches
No history of mental illness, epilepsy and malignant diseases
Do not have any type of phobia
Do not suffer from the symptoms of stimulant use and drug poisoning
Not under the treatment of a psychiatrist for all kinds of cognitive and psychosomatic disorders</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to cooperate at any stage of the plan
Urine test for morphine, amphetamine and hashish is checked three times for each person during the study, and if the test is positive, the person is excluded from the study.
Having psychotic symptoms
Pregnant women
Use of special psychiatric or neurological drugs affecting cognition, such as antipsychotics</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 - Devices</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 33 study intervention participants are justified for a period of 12 weeks not to change their normal physical and nutritional activities during this period of study. Patients are evaluated once a week by a free urine addiction test and the patients' non-slip test by a trained expert. is controlled.This intervention can be done with virtual reality glasses. Therefore, its tools are a three-dimensional display similar to the combination of large glasses with a hat. There are two very small monitors in it that cover a wide field of viewThe visualization for this intervention in this software is not adapted and has an atmosphere that reminds of the conditions for consuming morphine, heroin, or hashish, and is covered with old clothes and sitting and messy dishes that create a feeling of numbness and discomfort. It induces the person and the possibility and conditions of abstinence and staying away from substances are embedded in it.The main character who is a patient of addiction, by choosing the right and folding clothes, arranging the room, has a clean house, he knows that he has done abstinence, and also by destroying the tools of use, he adds to the score of the user, if the patient is towards drug use and touching the tools with the intention of use. Broad misses the chance to score from it. And the troubling images of Trustak will also see the condition of a patient with severe addiction and its side effects, which is disgusting and will receive strange and scary sounds .</i_keyword>
      <i_keyword>Intervention group: The second intervention: 33 addiction patients who receive psychological counseling during the study period, the discussions are conducted by a counselor. The psychological counselor is a senior psychology expert who has completed MMT methadone therapy, CBT and schema therapy.</i_keyword>
      <i_keyword>Intervention group: Intervention group: Third intervention: 33 patients using methadone with a routine dose in maintenance treatment are subjected to methadone intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>DDQ momentary consumption craving measurement - in the consumption craving questionnaire, the number 0 indicates the absence of an experience or feeling and the number 5 indicates the maximum presence of an experience or feeling. Timepoint: 12 weeks. Method of measurement: All people who enter the study, in addition to the demographic questionnaire, the momentary craving measurement questionnaire (DDQ); Bramson addiction withdrawal self-efficacy questionnaire; Beck depression questionnaire; They are completed and measured once before entering the study and once after 12 weeks of study.                                The virtual reality intervention was done once a week for about 6 minutes for the people who entered this part of the study; And the exams and the process of increasing or decreasing the points are finally checked and compared. In this way, the score of each person subjected to instrumental intervention is known at the end of each week, and it is announced to them.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>It has no variable consequences. Timepoint: They are completed and evaluated once before entering the study and once after 12 weeks of the study. Method of measurement: Beck Depression Inventory (BDI) This questionnaire, which contains 21 questions, was created by Beck et al. in order to measure the feedback and symptoms of depressed patients. The drug was designed and used by Bramson (1999), it consists of 16 questions. According to Bramson's instructions regarding how to score, the answers were determined in the form of seven options and using a Likert scale (one point for each scale) as follows: 1-definitely no 2-probably no 3-maybe no 4- I can't say 5-Maybe yes 6-Possibly yes 7-Definitely yes The score range of this questionnaire was between 16 and 112.Scores are measured and compared once before the start of the study and once after 12 weeks.</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>All the financial resources of this research were independently provided by the researcher Dr. Nasim Sadeghi. International Pardis University is non-profit and has not accepted any fees.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-07</approval_date>
        <contact_name>Ethics Committee in Research Faculty of Medicine and Dentistry - Kashan University of Medical Scienc</contact_name>
        <contact_address>Ghotb ravandi Blv, Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
