Determining the Effect of Multimedia Education on Uncertainty in Women with Breast Cancer.
Design
A randomized clinical trial was a single-blind clinical trial. A total of 60 patients were selected. Simple and objective sampling was done based on entry and exit criteria.
Settings and conduct
Before the uncertainty intervention, two groups of test and control are measured, then the educational DVD is provided to the test group. The uncertainty of both groups is determined 1 and 2 months after the end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patient's willingness to participate in the study، Confirmation of breast cancer by an oncologist، Awareness of the patient from his illness (the disease has not been hidden from him)، Age 30 to 60 years old، At least six months have passed since they became infected and treated for cancer، Literacy to read and write in Persian، Access to the computer and the ability to use it at the beginner، level (Open CD and access information)، The lack of cognitive and mental problems، The absence of a history of chronic underlying disease such as multiple sclerosis, AIDS, heart and respiratory failure، The patient is not in the stage 4.
Exit criteria:Unwillingness to continue cooperation in the study، Immigration of the patient، Patient death
Intervention groups
Samples will be available in the DVD Intervention Team with educational content and training on how to use it and two weeks to view it. During this time, the researcher will remind the participants with SMS. The telephone number will be provided to them in order to be able to contact the researcher in the event of a problem or a question. In the control group, no intervention will be performed and only the uncertainty of the samples will be measured.
Main outcome variables
Multi-media education is expected to reduce uncertainty in women with breast cancer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180406039206N1
Registration date:2018-05-26, 1397/03/05
Registration timing:retrospective
Last update:2018-05-26, 1397/03/05
Update count:0
Registration date
2018-05-26, 1397/03/05
Registrant information
Name
sara sadat hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 2862
Email address
hosseyni.s@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-16, 1396/08/25
Expected recruitment end date
2018-01-15, 1396/10/25
Actual recruitment start date
2017-11-16, 1396/08/25
Actual recruitment end date
2018-02-01, 1396/11/12
Trial completion date
empty
Scientific title
The effects of multimedia education on illness uncertainty in women with breast cancer
Public title
The effects of multimedia education on illness uncertainty in women with breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Awareness of the patient
Have been at least six months old and have been treated for cancer.
Literacy to read and write in Farsi
Access to the computer and the ability to use it at the beginner level (Open CD and access information)
Lack of history of chronic underlying chronic diseases such as multiple sclerosis, AIDS, heart and respiratory failure
Patient is not at the end of stage (stage 4).
Age 30 to 60 years
Lack of cognitive and mental problems
Confirmation of breast cancer by an oncologist
Exclusion criteria:
Unwillingness to continue cooperation in the study
Immigration of the patient
death of the patient
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
One-step cluster sampling will be done, so that from among the oncology clinics of Omid and Ghaem in Mashhad and Neyshabur, each center will first use the registers of patients referring to each center, a list of affected women Breast cancer will be prepared as a sampling frame for 60- 30 years, and then, using a simple random method, the research units will be selected from this list and DVD will be provided with multimedia tutorials along with the training required for patient delivery.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blindness of this study is a single blind blind blinded only after the study participants are kept blind to the study groups.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشگاه علوم پزشکی گناباد
Street address
خیابان امام خمینی ، دانشگاه علوم پزشکی گناباد
City
گناباد
Province
Razavi Khorasan
Postal code
64199-43175
Approval date
2017-09-26, 1396/07/04
Ethics committee reference number
GMU.REC.1396.66
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduce uncertainty and improve health.
Timepoint
Uncertainty measurements before intervention and 1 and 2 months after intervention.
Method of measurement
Uncertainty questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Samples will be included in the DVD intervention group with relevant educational content. Then, they will be given instructions on how to use this DVD and a two-week timetable for viewing the training program. During these two weeks, the researcher will remind participants to use the multimedia broadcast app. They will also provide a telephone number to contact the researcher in the event of a problem or a question.
Category
N/A
2
Description
Control group: In the control group, no intervention is performed by the researcher, and only the uncertainty of the samples will be measured.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان 22 بهمن نیشابور
Full name of responsible person
سارا سادات حسینی
Street address
شهرک قدس، بلوار قدس غربی، پلاک 203
City
نیشابور
Province
Razavi Khorasan
Postal code
939784959
Phone
+98 51 4261 2862
Email
hosseinisara345@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
علی محمد پور
Street address
گناباد، حاشیه جاده آسیایی، دانشگاه علوم پزشکی گناباد
City
gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3514
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
سارا سادات حسینی
Position
دانشجو
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
شهرک قدس، بلوار قدس غربی، پلاک ۲۰۳
City
نیشابور
Province
Razavi Khorasan
Postal code
9319784959
Phone
+98 51 4261 2862
Email
hosseinisara345@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
سارا سادات حسینی
Position
دانشجو
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
شهرک قدس، بلوار قدس غربی، پلاک ۲۰۳
City
نیشابوز
Province
Razavi Khorasan
Postal code
9319784959
Phone
+98 51 4261 2862
Email
hosseinisara345@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
سارا سادات حسینی
Position
دانشجو
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
شهرک قدس، بلوار قدس غربی، پلاک ۲۰۳
City
نیشابور
Province
Razavi Khorasan
Postal code
9319784959
Phone
+98 51 4261 2862
Email
hosseinisara345@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
The impact of multimedia education on uncertainty in women with cancer
When the data will become available and for how long
2018
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Research studies
From where data/document is obtainable
email_hosseinisara345@yahoo.com
What processes are involved for a request to access data/document