<?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>IRCT20210719051944N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-31</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>the effect of virtually designed resilience improvement program on outcomes of chronic pain patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of virtually designed resilience improvement program on outcomes of chronic pain patients referred to Shiraz University of Medical Sciences affiliated clinics</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57624</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, at first all of the required patients (105 people) will be selected  based on inclusion criteria, using the convenience sampling method based on referring to the office of pain fellowship physicians, internal medicine, neurologists, neurosurgeons and rheumatology subspecialty ( Located in Shiraz University of Medical Sciences affiliated clinics). The selected individuals will then be randomly divided into three groups (two control groups and one intervention group). 35 patients are assigned to each group. To do this,  "Random Allocation Software" will be used. In this way, a number is assigned to each selected person from the available sampling stage, then the information is entered into the software and finally, by randomly selecting the numbers by the software, it is determined  that whom will be in which group. In order to reduce potential bias, the randomization process will be performed by a person (researcher assisted) who is not involved in other stages of the research, Blinding description: The general introduction of the studied groups will be done, but participants will be unaware of  the allocation of study groups. When taking the pre-test and post-test, the assessor will not be informed of which group of data is being evaluated. The statistical analyst will not know which group the data belongs to when analyzing.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to routine care, a "virtualized resilience promotion program" will be implemented for patients in this group. the educational contents will be sent to them in the form of  modules through the WhatsApp application. According to the content of the program, it is expected that 6 educational modules will be designed weekly and the contents of each module (with 6-7 minute duration) will be sent to patients every other day at specific times. Patients will be able to access and use educational materials at all hours of the day and night. Depending on the content of the program, a few short tests will be designed during the intervention to increase the interaction of participants. After reading and completing a module by the patient, the next module will be provided to him at the appointed time. Intervention 2: Control group (1): these patients will receive routine care. Intervention 3: Control group (2): In addition to routine care, they receive the content of the "Virtual Program for Pain Recognition, Causes and Factors Affecting Pain and Its Treatments". the educational contents will be sent to them in through the WhatsApp application.</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:
Unidentifiable information of the participants that is related to the main and secondary outcomes of the study (Resilience, pain intensity, pain disability, psychological and social well-being).

When:
1-2 months after the publication of the study results

To whom:
Researchers working in academic and scientific institutions as well as people working in industry.

Conditions:
The use of the results of the study by mentioning the source is unrestricted.

Where to obtain:
Dr. Niloofar Pasiar, 07136474254
Dr. Maryam Shayegan, 07136474254
Hajar Haghshenas, 07136474254, haghshenah@gmail.com

How to obtain:
The requested information can be obtained through the mentioned e-mail address and within a maximum period of one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Niloofar Pasyar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi Square, School of Nursing and Midwifery</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۱۱۹ - ۷۱۹۳۶</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>pasyarn@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Maryam Shayegan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi Square, Nursing and Midwifery School</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۱۱۹ - ۷۱۹۳۶</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>m2620.shaygan@gmail</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age &gt;18 years
Diagnosis of chronic pain according to ICD-11 criteria (all types of non-cancerous chronic pain), according to the patient's report
Willingness to participate in the study
Literacy of reading, writing and speaking in Persian
Having a smart phone with WhatsApp social network and the ability to work with it
Internet access</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having other chronic physical diseases such as cancer and MS, according to the patient's own report
Known chronic mental illness, according to the patient's own report
Diagnosis of cancer or any other chronic disease (such as MS) during the study
Occurrence of adverse events for the patient's relatives (severe mental or physical illness) such as accident, divorce, death, etc. during the study
Unwillingness to continue participating during the study
Participate in psychotherapy programs or receive psychological counseling in the last 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic pain syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to routine care, a "virtualized resilience promotion program" will be implemented for patients in this group. the educational contents will be sent to them in the form of  modules through the WhatsApp application. According to the content of the program, it is expected that 6 educational modules will be designed weekly and the contents of each module (with 6-7 minute duration) will be sent to patients every other day at specific times. Patients will be able to access and use educational materials at all hours of the day and night. Depending on the content of the program, a few short tests will be designed during the intervention to increase the interaction of participants. After reading and completing a module by the patient, the next module will be provided to him at the appointed time.</i_keyword>
      <i_keyword>Control group (1): these patients will receive routine care.</i_keyword>
      <i_keyword>Control group (2): In addition to routine care, they receive the content of the "Virtual Program for Pain Recognition, Causes and Factors Affecting Pain and Its Treatments". the educational contents will be sent to them in through the WhatsApp application.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience level in CD- resilience questionnaire. Timepoint: before intervention, immediately and 3 mounts after intervention. Method of measurement: CD- resilience questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain intensity. Timepoint: before intervention, immediately and 3 mounts after intervention. Method of measurement: numeric rating scale.</sec_outcome>
      <sec_outcome>Pain disability. Timepoint: before intervention, immediately and 3 mounts after intervention. Method of measurement: pain disability index.</sec_outcome>
      <sec_outcome>Psychological wellbeing. Timepoint: before intervention, immediately and 3 mounts after intervention. Method of measurement: Ryff psychological wellbeing questionnaire (short form).</sec_outcome>
      <sec_outcome>Social wellbeing. Timepoint: before intervention, immediately and 3 mounts after intervention. Method of measurement: Keyes social wellbeing questionnaire (short form).</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-03</approval_date>
        <contact_name>Research Ethics committees of schools of nursing and midwifery, management and medical information s</contact_name>
        <contact_address>Namazi Square, School of nursing and midwifery Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
