<?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>IRCT20211121053121N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-26</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Roy Adaptation Model on the Quality of Life of People with Opioid Abuse under Methadone Maintenance Therapy</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Roy Adaptation Model on the Quality of Life of People with Opioid Abuse under Methadone Maintenance Therapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60127</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The present study is a single-blind clinical trial and includes two intervention and control groups. The whole study was conducted over a period of three months. The control group was evaluated in the first month and a half and the intervention group in the second month and a half, Randomization description: Samples were randomly divided into intervention and control groups with a random number table. So that the method of reading numbers by the researcher from top to bottom and even numbers were assigned to the intervention group and odd numbers to the control group, Blinding description: Patients in the intervention and control groups did not know the difference between routine interventions and interventions in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Quality of Life. Condition 2: Opioid Abuse. Condition 3: Methadone Maintenance Therapy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention was based on the Roy adaptation model in four areas: physiological, self-perception, role-playing and independence, and belonging based on observation, interview, and measurement by the researcher. After determining the maladaptation, the interventions in the framework of the nursing process were continued as follows: 1. Determining standard nursing diagnoses that include maladaptive behaviors and behaviors that may be maladaptive in the future. 2. Planning and setting goals, in which the goals were determined on a need-by-case basis. Then the necessary nursing care to achieve the desired goals was identified. Nursing care included interventions in which the primary, underlying, and residual stimuli were modified until the primary stimulus was in the direction of individual adjustment. 3. Execution, in which the researcher acted as an external moderator to expand the scope of individual adaptation and establish a consistent behavior. The researcher changed or adjusted stimuli and conditions, not persons, thus promoting the relationship of individuals with the environment and was effective in maintaining health. At this stage, based on the needs of patients, interventions were performed individually or in groups. 4. Evaluation, in which the researcher re-evaluates pre-defined goals and plans. At this stage, the researcher examined the amount of achievement of goals and determined the degree of adaptation in the areas of health and disease. Intervention 2: Control group: After the evaluation in the intervention group, if the interventions will be useful, the necessary training, recommendations and interventions will be provided to 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>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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Abbas Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing and Midwifery</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7504</telephone>
        <email>a_hoseini@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Abbas Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing and Midwifery</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7504</telephone>
        <email>a_hoseini@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be able to read and write
Do not have severe physical and mental illnesses
Have the interest and satisfaction to participate in this research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Try to quit opium less than twice
Has no history of using private or public addiction treatment centers</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z72.9</hc_code>
      <hc_code>F11.188</hc_code>
      <hc_code>T40.3X5D</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problem related to lifestyle, unspecified</hc_keyword>
      <hc_keyword>Opioid abuse with other opioid-induced disorder</hc_keyword>
      <hc_keyword>Adverse effect of methadone, subsequent encounter</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention was based on the Roy adaptation model in four areas: physiological, self-perception, role-playing and independence, and belonging based on observation, interview, and measurement by the researcher. After determining the maladaptation, the interventions in the framework of the nursing process were continued as follows: 1. Determining standard nursing diagnoses that include maladaptive behaviors and behaviors that may be maladaptive in the future. 2. Planning and setting goals, in which the goals were determined on a need-by-case basis. Then the necessary nursing care to achieve the desired goals was identified. Nursing care included interventions in which the primary, underlying, and residual stimuli were modified until the primary stimulus was in the direction of individual adjustment. 3. Execution, in which the researcher acted as an external moderator to expand the scope of individual adaptation and establish a consistent behavior. The researcher changed or adjusted stimuli and conditions, not persons, thus promoting the relationship of individuals with the environment and was effective in maintaining health. At this stage, based on the needs of patients, interventions were performed individually or in groups. 4. Evaluation, in which the researcher re-evaluates pre-defined goals and plans. At this stage, the researcher examined the amount of achievement of goals and determined the degree of adaptation in the areas of health and disease.</i_keyword>
      <i_keyword>Control group: After the evaluation in the intervention group, if the interventions will be useful, the necessary training, recommendations and interventions will be provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life in people with opioid abuse under methadone maintenance therapy. Timepoint: Before intervention and immediately after intervention. Method of measurement: Short Form (36) Health Survey.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-13</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing, Management and Rehabilitation Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
