Protocol summary
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Study aim
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Determining the effect of Self-care education on Face-to-Face and Videoclip on self-efficacy and quality of life in adolescents with congenital heart disease
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Design
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Semi-experimental study with three groups (two groups of intervention and control group), with parallel groups, randomized, design of111 patients
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Settings and conduct
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The total number of samples will be 111 (37 individuals each), which will be included in the sampling among adolescents with heart disease in the selected hospital (Shahid Rajaee Cardiology Hospital). In the control group, the education group Face-to-face and training group will be clipped with video. The way of work is that before the implementation of educational methods, the pre-test will be taken from all three groups and two months after implementation of the training methods in the two intervention groups, the post-test will be taken from all three groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
18-21 year-old adolescents with congenital heart disease; Having Satisfaction; Have at least the ability to read and write; A home theater display device to see the educational video; Has not participated in similar educational programs. exclusion criteria: Cases of other chronic diseases.
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Intervention groups
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Intervention group1(Face-to-face education group): Face-to-face self-care education is one for each person in two sessions of 35 to 45 minutes and one week apart.
Intervention group2 (Educational video clip group): Educational video clip The study included a compact disc made by a researcher and media consultant.
Control group: receive routine hospital training.
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Main outcome variables
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Self-efficacy; Quality of life
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180417039341N1
Registration date:
2018-06-13, 1397/03/23
Registration timing:
registered_while_recruiting
Last update:
2020-06-21, 1399/04/01
Update count:
1
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Registration date
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2018-06-13, 1397/03/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-05-10, 1397/02/20
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Expected recruitment end date
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2018-07-11, 1397/04/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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To compare the effectiveness of self-care education in two methods, face to face and video educational, on the self-efficacy and quality of life in adolescents with congenital heart disease
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Public title
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Evaluation of self-care education on self-efficacy and quality of life in adolescents with congenital heart disease
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
18-21 year-old adolescents with congenital heart disease who have come to the clinic at least once a year.
The adolescents has the consent to participate in the study.
Have at least the ability to read and write.
At least 6 months have passed since the initial diagnosis of their illness.
A home theater display device to see the educational video.
Has not participated in similar educational programs (with the exception of the routine program) over the past year.
Exclusion criteria:
Hearing and vision impairment, and other chronic diseases.
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Age
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From 18 years old to 21 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
111
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-11-06, 1396/08/15
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Ethics committee reference number
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IR.IUMS.FMD.REC.1396.9311687003
Health conditions studied
1
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Description of health condition studied
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Congenital Heart Disease
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ICD-10 code
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Q24.9
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ICD-10 code description
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Congenital malformation of heart, unspecified
Primary outcomes
1
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Description
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Self-efficacy score in SHERER questionnaire
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Timepoint
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Measurement of self-efficacy at the beginning of the study (before intervention) and 2 months after face-to-face training and educational video clip
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Method of measurement
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SHERER Self-efficacy questionnaire
2
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Description
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Quality of Life Score in the WHO Quality of Life-BREF Questionnaire
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Timepoint
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Measurement of quality of life at the beginning of the study (before intervention) and 2 months after face-to-face training and video clip training
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Method of measurement
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WHO Quality of Life-BREF Quality of Life Questionnaire
Intervention groups
1
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Description
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First intervention group: Face to face education individually per person in two sessions of 35 to 45 minutes, intervals of one week about 1- Description of heart defect and treatment 2- Prevention of complications 3- Physical activities 4. Fertility and genetic health 5 Prevention and Pregnancy Program.
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Category
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Rehabilitation
2
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Description
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Second intervention group: Educational video clip In this study, a compact disc was developed by a researcher and assisted by a media consultant, which included educational content: a description of congenital heart disease and treatment in summary and simple language, along with moving pictures, teaching common complications And prevention of them in the form of lectures, the scope of physical activity in different patients, the education of reproductive health and appropriate prevention methods in the form of lectures
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Category
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Rehabilitation
3
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Description
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Control group: Get a routine hospital training program
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Individual data of the participants as well as the final results of self-efficacy and their quality of life in the study after unidentifiable individuals can be shared.
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When the data will become available and for how long
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Start the 6 month period after the results are printed
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To whom data/document is available
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All individuals can use the results of this research if necessary.
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Under which criteria data/document could be used
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Using the results of the research to raise the level of science and also use its results in conducting other research.
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From where data/document is obtainable
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Parisa hasannezhad:
Email: parisa.hasannezhad@yahoo.com
Address: Shaheed Rajaei Cardiovascular Medical and Research Center., Valiasr Ave., Niayesh Intersection., Tehran., Iran
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What processes are involved for a request to access data/document
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After registering the data, the applicant, upon request, sends the email to the researcher, and the purpose of the request is to explain the results and the results, and will be sent to them by email within the shortest possible time after the review by the researcher.
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Comments
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