<?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>IRCT20191127045524N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-13</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The effect of multimedia training and peer training on perceived Stress</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effects of Multimedia Education and Peer Education on Perceived Stress in Cancer Patients Undergoing Chemotherapy: A Parallel Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72556</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sequence of random allocation will be done by the statistical consultant with the help of Spss software. Patients will be randomly placed in three groups A (multimedia training), B (peer training) and C (control) based on the order determined by the software, and the sampling process will be done consecutively until the end of sampling. took Individuals are assigned to the desired group in the order of their entry into the study and randomly through randomized blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cancer and Chemotherapy.</hc_freetext>
      <i_freetext>Intervention group: The number of 3 patients who had a history of successful treatment with chemotherapy and were selected as peers in consultation with the medical personnel of the relevant department and after obtaining informed consent from the individuals and during three one-hour sessions, two of which were training sessions. necessary in the field of disease recognition, chemotherapy nursing care, nutrition care, drug therapy care and important training and necessary nursing care in cancer and chemotherapy by trained nurses and with the guidance of specialized nursing personnel in this field, In the training room of the chemotherapy department of the hospital environment, training will be provided and finally a meeting will be held with the aim of measuring the level of preparation of peers. Also, during the meeting, these people will be emphasized that the training will only be given to the people who have been introduced to They will do it according to random allocation and during this period they will be monitored and controlled by the specified nurses of the relevant department and after confirming their complete preparation they will be introduced to the people of the peer education intervention group in a meeting and then The steps of the intervention will be conducted under the supervision of a trained nurse during 4 sessions, a one-hour session every week, and at the end of the sessions, the level of their learning will be measured by the question and answer method (at the end, the training related to each session is attached). and each person will be excluded from the study if he does not participate in the meetings and does not respond for two consecutive weeks, which is determined according to the activity and inactivity form attached at the end) and then after one week from the last The perceived stress questionnaire session will be completed again. Also, the trainings of the multimedia training group are also provided by videos prepared by nurses specializing in cancer patients in the form of 10-15 minute videos, as well as providing educational and care materials in the field of cancer and chemotherapy on a weekly and coordinated basis. A specific day with peer group training in the group created for 4 weeks will be sent to individuals through internal messengers (at the end, the training related to each session is attached, and each person, in case of not participating in the sessions and not responding) for two consecutive weeks, which is determined according to the activity and inactivity form attached at the end, will be removed from the study) and then after one week from the last sent item, the perceived stress questionnaire will be completed again. In the control group, patients will be given routine training including educational pamphlets and training given by nurses during the treatment period. During these 4 weeks of follow-up of people to participate in peer training sessions and also to observe multimedia training, a trained nurse will follow up on this through phone calls..</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:
Part of the patient's demographic information is shared after people have not been identified. All information related to measuring worry and blood pressure in patients can be shared after people have not been identified.

When:
En Access starts 6 months after results are published

To whom:
Researchers and students of academic and scientific institutions

Conditions:
Raw data for correlation studies

Where to obtain:
Amirheidar Bakhshiarab 
amirheidari770@gmail.com

How to obtain:
Clear explanation of the reason for the need to access data and provide data after two weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirheidar Bakhshiarab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Square, Research and Technology, Shahroud University Medical Science, Shahroud Town</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 3222 4816</telephone>
        <email>amirheidari770@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amiheidar Bakhshiarab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Square, Research and Technology, Shahroud University Medical Science, Shahroud Town</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 3222 4816</telephone>
        <email>amirheidari770@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having literacy in reading and writing
Understanding and speaking in Persian language
Confirmation of cognitive status based on Mini-Cog
Ability to use a smartphone.
Ability to use a smartphone, access to Eita internal messengers.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having education related to medicine
Nervous and mental disorders based on patients' self-report
People present in other similar research projects
Non-response of the people present in the multimedia training intervention group during follow-ups for two weeks
Failure to participate in two face-to-face peer training sessions
Participation in extracurricular educational programs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z51.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for antineoplastic chemotherapy and immunotherapy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The number of 3 patients who had a history of successful treatment with chemotherapy and were selected as peers in consultation with the medical personnel of the relevant department and after obtaining informed consent from the individuals and during three one-hour sessions, two of which were training sessions. necessary in the field of disease recognition, chemotherapy nursing care, nutrition care, drug therapy care and important training and necessary nursing care in cancer and chemotherapy by trained nurses and with the guidance of specialized nursing personnel in this field, In the training room of the chemotherapy department of the hospital environment, training will be provided and finally a meeting will be held with the aim of measuring the level of preparation of peers. Also, during the meeting, these people will be emphasized that the training will only be given to the people who have been introduced to They will do it according to random allocation and during this period they will be monitored and controlled by the specified nurses of the relevant department and after confirming their complete preparation they will be introduced to the people of the peer education intervention group in a meeting and then The steps of the intervention will be conducted under the supervision of a trained nurse during 4 sessions, a one-hour session every week, and at the end of the sessions, the level of their learning will be measured by the question and answer method (at the end, the training related to each session is attached). and each person will be excluded from the study if he does not participate in the meetings and does not respond for two consecutive weeks, which is determined according to the activity and inactivity form attached at the end) and then after one week from the last The perceived stress questionnaire session will be completed again. Also, the trainings of the multimedia training group are also provided by videos prepared by nurses specializing in cancer patients in the form of 10-15 minute videos, as well as providing educational and care materials in the field of cancer and chemotherapy on a weekly and coordinated basis. A specific day with peer group training in the group created for 4 weeks will be sent to individuals through internal messengers (at the end, the training related to each session is attached, and each person, in case of not participating in the sessions and not responding) for two consecutive weeks, which is determined according to the activity and inactivity form attached at the end, will be removed from the study) and then after one week from the last sent item, the perceived stress questionnaire will be completed again. In the control group, patients will be given routine training including educational pamphlets and training given by nurses during the treatment period. During these 4 weeks of follow-up of people to participate in peer training sessions and also to observe multimedia training, a trained nurse will follow up on this through phone calls.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived stress score in Cohen's questionnaire. Timepoint: At the beginning of the study (before the intervention) and 4 weeks after the intervention. Method of measurement: Cohen's Perceived Stress Questionnaire. The lowest score is 0 and the highest score is 56. A higher score indicates greater perceived stress.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-30</approval_date>
        <contact_name>Ethics Committee in Research of Shahroud University of Medical Sciences</contact_name>
        <contact_address>7th Square, Research and Technology, Shahroud University of Medical Science, Shahroud Town Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
