<?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>IRCT20230930059559N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-20</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Remote Education based on Self-Efficacy Theory</public_title>
      <acronym>RESET</acronym>
      <scientific_title>Examining the effectiveness of a remote educational intervention based on self-efficacy theory in reducing job burnout among healthcare workers with occupational low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72869</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In the first phase, a cross-sectional study is conducted to describe the society, in which all people are examined. In the next phase, a sample of these people is selected and assigned to two intervention and control groups by a simple random method. For this purpose, first, the list of employees with personnel code and mobile number is received from the administrative affairs unit through the coordinator. The personnel code of all the selected people is written on the envelope and then placed in an opaque container. Then 88 envelopes are randomly selected from the container by a third party. The first envelope is considered for the intervention group, the second envelope for the control group, and so on until the 88th envelope, one for the intervention group and one for the control group. To ensure the concealment of the random allocation of the envelopes, the coordinator (outside the research team) blindly selects the envelopes from the non-transparent container, Blinding description: Researchers or outcome assessors are unaware of study group allocation. A person as a coordinator will assign the groups randomly based on the personnel code.</study_design>
      <phase>3</phase>
      <hc_freetext>Job burnout.</hc_freetext>
      <i_freetext>Intervention 1: Prior to implementing the intervention, an educational program is designed based on self-efficacy theory and pre-tested. For the pre-testing, the educational program will be provided to two health education specialists, two orthopedic specialists, and ten healthcare workers for content and execution assessment. If needed, feedback from individuals and experts will be incorporated into the program, and the final file will be prepared for presentation. The educational content includes a general section, ergonomic principles, back stretching and strengthening exercises, self-efficacy and ways to enhance it, job fatigue and its factors, coping strategies with job fatigue. In the next stage, the educational intervention will be delivered through social media for 5 days, with a duration of one hour per day for the target group. After the intervention ends, a weekly reminder message will be sent to individuals through social media or text messages. The impact of the educational program will be evaluated three months after the intervention. Intervention 2: Control group: Will not receive training. After the three-month follow-up and at the end of the project, the educational content 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All personal data of participants can be shared after de-identification.

When:
The access period starts immediately after the results are printed.

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

Conditions:
In the case of using the results of the study or designing an educational intervention in similar studies.

Where to obtain:
via the corresponding author's email. Seyedeh somayeh Kazemi (somayeh.kazemi7@gmail.com)

How to obtain:
Contact the corresponding author by email and send it within ten working days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh_Somayeh Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Km 18 of Khazarabad Road, Complex of University of Medical Sciences of the Prophet</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4847116548</zip>
        <telephone>+98 11 3354 3317</telephone>
        <email>so.kazemi@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh_Somayeh Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Km 18 of Khazarabad Road, Complex of University of Medical Sciences of the Prophet</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4847116548</zip>
        <telephone>+98 11 3354 3317</telephone>
        <email>so.kazemi@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male and female health workers
Having non-specific back pain related to work for 12 weeks or more (based on the diagnosis of a physical medicine specialist)
Internet access and online services</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any disease that prevents the person from participating in the study
Pregnancy
Having back pain with any pathological cause
Taking medicine to reduce back pain according to doctor's prescription</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>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Prior to implementing the intervention, an educational program is designed based on self-efficacy theory and pre-tested. For the pre-testing, the educational program will be provided to two health education specialists, two orthopedic specialists, and ten healthcare workers for content and execution assessment. If needed, feedback from individuals and experts will be incorporated into the program, and the final file will be prepared for presentation. The educational content includes a general section, ergonomic principles, back stretching and strengthening exercises, self-efficacy and ways to enhance it, job fatigue and its factors, coping strategies with job fatigue. In the next stage, the educational intervention will be delivered through social media for 5 days, with a duration of one hour per day for the target group. After the intervention ends, a weekly reminder message will be sent to individuals through social media or text messages. The impact of the educational program will be evaluated three months after the intervention.</i_keyword>
      <i_keyword>Control group: Will not receive training. After the three-month follow-up and at the end of the project, the educational content will be provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Job burnout. Timepoint: Baseline and 3-months follow up. Method of measurement: Maslach Burnout Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self-efficacy. Timepoint: Baseline and 3-month follow up. Method of measurement: General Self-Efficacy Scale-GSE.</sec_outcome>
      <sec_outcome>Low Back Pain. Timepoint: Baseline and 3-month follow up. Method of measurement: Visual Analogue 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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-18</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Moalem Square, Moalem Ave., Ayatollah Taleghani Ave., Research and Technology Deputy Building Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
