Comparing the Effects of Multimedia Education and Peer Education on Perceived Stress in Cancer Patients Undergoing Chemotherapy: A Parallel Randomized Clinical Trial
Determining the effect of multimedia Education and peer Education on perceived stress in cancer patients undergoing chemotherapy in the Omid Department of Imam Hossein Shahroud Hospital in 2023
Design
A clinical trial study with a control group, with parallel groups, without blinding, randomized, on 110 cancer patients undergoing chemotherapy, will use statistical consultant with SPSS software for randomization.
Settings and conduct
Online multimedia trainings and face-to-face peer group trainings will be implemented for cancer patients undergoing chemotherapy referred to Imam Hossein (AS) Shahroud Hospital. Trainings are given for four weeks every week on a specific topic.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being literate in reading and writing, understanding and speaking Persian language, ability to use a smartphone, access to ITA internal messengers, confirmation of cognitive status based on Mini-Cog, Exclusion criteria: having education related to medicine, neurological disorders and Psychosis based on the self-report of patients, people in other similar research projects, non-response of people in the multimedia training intervention group during follow-ups for two weeks, non-participation in two face-to-face peer training sessions, participation in educational programs Extracurricular
Intervention groups
The intervention group includes cancer patients undergoing chemotherapy who receive the intervention of multimedia education and peer education for four weeks online and face-to-face according to their placement in the intervention group. The control group includes cancer patients undergoing chemotherapy who only receive routine training at the treatment center during this period.
Main outcome variables
Perceived Stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191127045524N3
Registration date:2023-09-13, 1402/06/22
Registration timing:prospective
Last update:2023-09-13, 1402/06/22
Update count:0
Registration date
2023-09-13, 1402/06/22
Registrant information
Name
Amirheidar Bakhshiarab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3222 4816
Email address
bakhshiarab@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of Multimedia Education and Peer Education on Perceived Stress in Cancer Patients Undergoing Chemotherapy: A Parallel Randomized Clinical Trial
Public title
The effect of multimedia training and peer training on perceived Stress
Purpose
Education/Guidance
Inclusion/Exclusion 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.
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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Shahroud University of Medical Sciences
Street address
7th Square, Research and Technology, Shahroud University of Medical Science, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2023-08-30, 1402/06/08
Ethics committee reference number
IR.SHMU.REC.1402.099
Health conditions studied
1
Description of health condition studied
Cancer and Chemotherapy
ICD-10 code
Z51.1
ICD-10 code description
Encounter for antineoplastic chemotherapy and immunotherapy
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein (AS) Shahroud Hospital
Full name of responsible person
Amirheidar Bakhshiarab
Street address
7th Square, Research and Technology, Shahroud University of Medical Science, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3222 4816
Email
amirheidari770@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
7th Square, Research and Technology, Shahroud University Medical Science, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3222 4816
Email
amirheidari770@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Amirheidar Bakhshiarab
Position
Faculty of Shahroud University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
7th Square, Research and Technology, Shahroud University Medical Science, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3222 4816
Email
amirheidari770@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Amiheidar Bakhshiarab
Position
Faculty of Shahroud University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
7th Square, Research and Technology, Shahroud University Medical Science, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3222 4816
Email
amirheidari770@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Amirheidar Bakhshiarab
Position
Faculty of Shahroud University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
7th Square, Research and Technology, Shahroud University Medical Science, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3222 4816
Email
amirheidari770@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
En Access starts 6 months after results are published
To whom data/document is available
Researchers and students of academic and scientific institutions
Under which criteria data/document could be used
Raw data for correlation studies
From where data/document is obtainable
Amirheidar Bakhshiarab
amirheidari770@gmail.com
What processes are involved for a request to access data/document
Clear explanation of the reason for the need to access data and provide data after two weeks