<?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>IRCT20181023041426N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-11</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of  Educational Intervention Based on Roy's Adaptation model on the Psychosocial Adjustment of patients with Permanent Pacemaker</public_title>
      <acronym>PSAKH</acronym>
      <scientific_title>Effectiveness of  Educational Intervention Based on Roy's Adaptation model on the Psychosocial Adjustment of patients with Permanent Pacemaker</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34695</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Other design features: The Study is Based on the ROY Adaptation   Model, which is a nursing compatibility model.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Psychosocial Adjustment.</hc_freetext>
      <i_freetext>Intervention group: Patients with Pacemakers. The intervention will be conducted in accordance with a training protocol prepared by the care team (Researcher Nurse, relevant Physician, and Psychologist). The theoretical and practical program with lecture notes and lectures, with the help of slides and short films, include: (teaching patients about: heart function, definition of an Arrhythmia, Pacemaker function and physical risk factors And non-physical with illness and Pacemaker - in Psychological problems such as depression - Anxiety - Disturbance in the body of mind - decentralization - isolation and ... also social problems such as job loss - communicating with family and others - Participating in communities - adapting to the social environment ...) in 4 training sessions of 40 minutes and during 2 weeks in the conference hall Shaheed Madani Hospital will be offered. Meanwhile, after the end of the sessions, they will be in constant contact with the patients once a month (for one month) and their questions will be answered about their situation..</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 participants' data are shareable in the study. However, the outcomes of the study are more relevant

When:
Access is available 6 months after the results are published.

To whom:
Scientific and academic Nursing  researchers from Medical Sciences have access to the documentation.

Conditions:
Any Analysis is allowed by the Professor. Use for research and research in Nursing and Medical Sciences is allowed. The requirements for sending Nursing and Medical Science groups can be provided.

Where to obtain:
Khorram Abad University of Medical Sciences - Boroujerd Road 4 - Pardis University Campus - Faculty of Nursing - Dr. Tahereh Toloabi
Mailbox: 381351698
Telex: 33120140-066
E-mail: Tolabi.t@lums.ac.ir
College Education: 33120155-066- 33120166-066 - Internal 403 and  403

How to obtain:
First, Contact by email with Dr. Tolabi  office to get permission to access the next document if Dr. Tolabi's permission is granted. Documentation will be sent by him or by Elham Nassiri's student.

Comments:
This Study is based on Nursing Models. It is widely used in studies that are supposed to work on patients based on Nursing Models or to work on adaptation in chronic patients.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham  Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West  Sarve  Ave , Ostandari  Street ,kheirabad</address>
        <city>khoramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6813953495</zip>
        <telephone>+98 66 3342 4365</telephone>
        <email>nasirielham55@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr .Tahere Tolabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kamalwand 4 km of Boroujerd Road</address>
        <city>Khorab abad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381351698</zip>
        <telephone>+98 66 3312 0155</telephone>
        <email>Tolabi.t@lums.ac.ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Patients who have Permanent Pace maker in their bodies   .
2. One month after the pacemaker has been used in the patient's body.
3. the   patient should express his consent to participate in the training program .
4. Patient  should be introduced by the doctor to participate in the research
5. A person can understand Give the subject.
6. Age between 20-70 years
7. Lack of serious disabling illness, such as COPD - Blindness - Cancer .
8. Lack of any psychological problem
9. Lack of any hearing impairment - Vision - Speech
10. To Know Farsi language
11. Having a  mobile  or  phone</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Not having Patient's tendency  to assist in research.
2. Unfavorable physical condition
3. Participating in any kind of effective workshop on the level of compatibility
4. Use of drugs that affect fluency</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>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients with Pacemakers. The intervention will be conducted in accordance with a training protocol prepared by the care team (Researcher Nurse, relevant Physician, and Psychologist). The theoretical and practical program with lecture notes and lectures, with the help of slides and short films, include: (teaching patients about: heart function, definition of an Arrhythmia, Pacemaker function and physical risk factors And non-physical with illness and Pacemaker - in Psychological problems such as depression - Anxiety - Disturbance in the body of mind - decentralization - isolation and ... also social problems such as job loss - communicating with family and others - Participating in communities - adapting to the social environment ...) in 4 training sessions of 40 minutes and during 2 weeks in the conference hall Shaheed Madani Hospital will be offered. Meanwhile, after the end of the sessions, they will be in constant contact with the patients once a month (for one month) and their questions will be answered about their situation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychosicial Adjustment. Timepoint: The Demographic Characteristics and the form of examination and recognition on the first session and the Psychosocial Adjustment  to Illness   Scale   immediately After the intervention, one month and three months later After the intervention, will be completed by questioning the patient through the researcher's assistance (four times the questionnaire will be completed). Method of measurement: Including Demographic Specification Form - Standard Questionnaire on Knowledge of ROY - Psychosocial   Adjustment  to Illness   Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Compatibility time. Timepoint: Beginning of the study (before the intervention) -Immediately after the intervention - one month after the intervention - three months after the intervention. Method of measurement: Psychosocial   Adjustment  to Illness   Scale.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-23</approval_date>
        <contact_name>Ethics Committee of Khorramabad University of Medical Sciences</contact_name>
        <contact_address>Khorram Abad Mole Student, Shahid Anooshirvan Rezaei Square, Medical Sciences University Khoram abad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
