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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General information
In order to prevent data leakage, intervention groups and controls will be selected in different weeks. In this way, the names of the three groups (face to face, video clip and control) will be written on the card and placed in envelopes in the package. These envelopes are placed in a box, and the researcher does not know which groups of subjects are under study in that week before choosing a card. Randomization tool was sealed. At the beginning of each week, the researcher, before exposing patients, removes one of the envelopes from the box, which patients will be included in the study week. This random selection will be repeated until the sample size reaches.
In order to prevent data leakage, intervention groups and controls will be selected in different weeks. In this way, the names of the three groups (face to face, video clip and control) will be written on the card and placed in envelopes in the package. These envelopes are placed in a box, and the researcher does not know which groups of subjects are under study in that week before choosing a card. Randomization tool was sealed. At the beginning of each week, the researcher, before exposing patients, removes one of the envelopes from the box, which patients will be included in the study week. This random selection will be repeated until the sample size reaches.
جهت جلوگیری از نشت اطلاعات، گروههای مداخله و کنترل در هفتههای مختلف انتخاب خواهند شد. در این روش نام سه گروه (چهره به چهره، ویدیو کلیپ و کنترل) بر روی کارت نوشته و در پاکتهای در بسته قرار داده خواهد شد. این پاکتها درون یک جعبه قرار داده میشود و پژوهشگر تا قبل از انتخاب کارت نمیداند که واحدهای مورد پژوهش در آن هفته در کدام گروه قرار میگیرند که در ابتدای هر هفته پژوهشگر پیش از مواجهه با بیماران با برداشتن یکی از پاکتها از جعبه مشخص میکند که بیمارانی که در آن هفته وارد مطالعه خواهند شد در کدام گروه قرار خواهند گرفت. این انتخاب شبه تصادفی تا رسیدن به حجم نمونه تکرار خواهد شد.
جهت جلوگیری از نشت اطلاعات، گروههای مداخله و کنترل در هفتههای مختلف انتخاب خواهند شد. در این روش نام سه گروه (چهره به چهره، ویدیو کلیپ و کنترل) بر روی کارت نوشته و در پاکتهای در بسته قرار داده خواهد شد. این پاکتها درون یک جعبه قرار داده میشود و پژوهشگر تا قبل از انتخاب کارت نمیداند که واحدهای مورد پژوهش در آن هفته در کدام گروه قرار میگیرند که در ابتدای هر هفته پژوهشگر پیش از مواجهه با بیماران با برداشتن یکی از پاکتها از جعبه مشخص میکند که بیمارانی که در آن هفته وارد مطالعه خواهند شد در کدام گروه قرار خواهند گرفت. این انتخاب شبه تصادفی تا رسیدن به حجم نمونه تکرار خواهد شد.
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Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Seyed Kazem Malekoti
Full name of responsible person - Persian: دکتر سید کاظم ملکوتی
Street address - English: Iran University of Medical Sciences., Shahid Hemmat Highway.,Tehran.,Iran
Street address - Persian: استان تهران، تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 86701
Fax:
Email: hassannejad.p@tak.iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Seyed Kazem Malekoti
Full name of responsible person - Persian: دکتر سید کاظم ملکوتی
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
Street address - Persian: استان تهران، تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 86701
Fax:
Email: hassannejad.p@tak.iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Seyed Kazem Malekoti Full name of responsible person - Persian: دکتر سید کاظم ملکوتی Street address - English: Iran University of Medical Sciences., Shahid Hemmat Highway.,Tehran.,IranHighway, Tehran, Iran Street address - Persian: استان تهران، تهران، بزرگراه همت، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 21 86701 Fax: Email: hassannejad.p@tak.iums.ac.ir Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parisa Hasannezhad
Full name of responsible person - Persian: پریسا حسن نژاد
Position - English: Masters Student of Pediatric Nursing
Position - Persian: دانشجوی کارشناسی ارشد پرستاری کودکان
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 118, Zamani Ave., Standard Square., Karaj., Iran
Street address - Persian: کرج، میدان استاندارد، کوچه زمانی، پلاک118
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3174714535
Phone: +98 21 2392 2477
Mobile: +98 935 894 3046
Fax:
Email: hassannejad.p@tak.iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parisa Hasannezhad
Full name of responsible person - Persian: پریسا حسن نژاد
Position - English: Masters Student of Pediatric Nursing
Position - Persian: دانشجوی کارشناسی ارشد پرستاری کودکان
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN
Street address - Persian: تهران، خیابان ولی عصر، بالاتر از میدان ونک، خیابان رشید یاسمی دانشکده پرستاری و مامایی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1996713883
Phone: +98 21 2392 2477
Mobile: +98 935 894 3046
Fax:
Email: hassannejad.p@tak.iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Parisa Hasannezhad Full name of responsible person - Persian: پریسا حسن نژاد Position - English: Masters Student of Pediatric Nursing Position - Persian: دانشجوی کارشناسی ارشد پرستاری کودکان Latest degree: bachelor Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 118School of Nursing & Midwifery, Zamani AveRashid Yasemi st., Standard SquareValiasr St., Karaj.Tehran, Iran1996713883, IRAN Street address - Persian: کرجتهران، خیابان ولی عصر، بالاتر از میدان استانداردونک، کوچه زمانی، پلاک118خیابان رشید یاسمی دانشکده پرستاری و مامایی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 31747145351996713883 Phone: +98 21 2392 2477 Mobile: +98 935 894 3046 Fax: Email: hassannejad.p@tak.iums.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parisa Hasannezhad
Full name of responsible person - Persian: پریسا حسن نژاد
Position - English: Masters Student of Pediatric Nursing
Position - Persian: دانشجوی کارشناسی ارشد پرستاری کودکان
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 118, Zamani Ave., Standard Square., Karaj., Iran
Street address - Persian: کرج، میدان استاندارد، کوچه زمانی، پلاک118
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3174714535
Phone: +98 21 2392 2477
Mobile: +98 935 894 3046
Fax:
Email: hassannejad.p@tak.iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parisa Hasannezhad
Full name of responsible person - Persian: پریسا حسن نژاد
Position - English: Masters Student of Pediatric Nursing
Position - Persian: دانشجوی کارشناسی ارشد پرستاری کودکان
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN
Street address - Persian: تهران، خیابان ولی عصر، بالاتر از میدان ونک، خیابان رشید یاسمی دانشکده پرستاری و مامایی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1996713883
Phone: +98 21 2392 2477
Mobile: +98 935 894 3046
Fax:
Email: hassannejad.p@tak.iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Parisa Hasannezhad Full name of responsible person - Persian: پریسا حسن نژاد Position - English: Masters Student of Pediatric Nursing Position - Persian: دانشجوی کارشناسی ارشد پرستاری کودکان Latest degree: bachelor Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 118School of Nursing & Midwifery, Zamani AveRashid Yasemi st., Standard SquareValiasr St., Karaj.Tehran, Iran1996713883, IRAN Street address - Persian: کرجتهران، خیابان ولی عصر، بالاتر از میدان استانداردونک، کوچه زمانی، پلاک118خیابان رشید یاسمی دانشکده پرستاری و مامایی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 31747145351996713883 Phone: +98 21 2392 2477 Mobile: +98 935 894 3046 Fax: Email: hassannejad.p@tak.iums.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parisa Hasannezhad
Full name of responsible person - Persian: پریسا حسن نژاد
Position - English: Masters Student of Pediatric Nursing
Position - Persian: دانشجوی کارشناسی ارشد پرستاری کودکان
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 118, Zamani Ave., Standard Square., Karaj., Iran
Street address - Persian: کرج، میدان استاندارد، کوچه زمانی، پلاک118
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3174714535
Phone: +98 21 2392 2477
Mobile: +98 935 894 3046
Fax:
Email: hassannejad.p@tak.iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parisa Hasannezhad
Full name of responsible person - Persian: پریسا حسن نژاد
Position - English: Masters Student of Pediatric Nursing
Position - Persian: دانشجوی کارشناسی ارشد پرستاری کودکان
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN
Street address - Persian: هران، خیابان ولی عصر، بالاتر از میدان ونک، خیابان رشید یاسمی دانشکده پرستاری و مامایی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1996713883
Phone: +98 21 2392 2477
Mobile: +98 935 894 3046
Fax:
Email: hassannejad.p@tak.iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Parisa Hasannezhad Full name of responsible person - Persian: پریسا حسن نژاد Position - English: Masters Student of Pediatric Nursing Position - Persian: دانشجوی کارشناسی ارشد پرستاری کودکان Latest degree: bachelor Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 118School of Nursing & Midwifery, Zamani AveRashid Yasemi st., Standard SquareValiasr St., Karaj.Tehran, Iran1996713883, IRAN Street address - Persian: کرجهران، خیابان ولی عصر، بالاتر از میدان استانداردونک، کوچه زمانی، پلاک118خیابان رشید یاسمی دانشکده پرستاری و مامایی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 31747145351996713883 Phone: +98 21 2392 2477 Mobile: +98 935 894 3046 Fax: Email: hassannejad.p@tak.iums.ac.ir Web page address:
Protocol summary
Study aim
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
Design
Semi-experimental study with three groups (two groups of intervention and control group), with parallel groups, randomized, design of111 patients
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Self-efficacy; Quality of life
General information
Reason for update
Acronym
IRCT registration information
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
Registration date
2018-06-13, 1397/03/23
Registrant information
Name
Parisa Hasannezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2477
Email address
hassannejad.p@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-10, 1397/02/20
Expected recruitment end date
2018-07-11, 1397/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of self-care education on self-efficacy and quality of life in adolescents with congenital heart disease
Purpose
Supportive
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 21 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
111
Randomization (investigator's opinion)
Not randomized
Randomization description
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 of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-11-06, 1396/08/15
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9311687003
Health conditions studied
1
Description of health condition studied
Congenital Heart Disease
ICD-10 code
Q24.9
ICD-10 code description
Congenital malformation of heart, unspecified
Primary outcomes
1
Description
Self-efficacy score in SHERER questionnaire
Timepoint
Measurement of self-efficacy at the beginning of the study (before intervention) and 2 months after face-to-face training and educational video clip
Method of measurement
SHERER Self-efficacy questionnaire
2
Description
Quality of Life Score in the WHO Quality of Life-BREF Questionnaire
Timepoint
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
Method of measurement
WHO Quality of Life-BREF Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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
Category
Rehabilitation
3
Description
Control group: Get a routine hospital training program
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajaei Cardiovascular Medical and Research Center
Full name of responsible person
Parisa Hassannezhad
Street address
Shaheed Rajaei Cardiovascular Medical and Research Center., Valiasr Ave., Niayesh Intersection., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
31747-14535
Phone
+98 21 2392 2477
Email
hassannejad.p@tak.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malekoti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
hassannejad.p@tak.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Parisa Hasannezhad
Position
Masters Student of Pediatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 2392 2477
Email
hassannejad.p@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Hasannezhad
Position
Masters Student of Pediatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 2392 2477
Email
hassannejad.p@tak.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Hasannezhad
Position
Masters Student of Pediatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran, 1996713883, IRAN
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 2392 2477
Email
hassannejad.p@tak.iums.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
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.
When the data will become available and for how long
Start the 6 month period after the results are printed
To whom data/document is available
All individuals can use the results of this research if necessary.
Under which criteria data/document could be used
Using the results of the research to raise the level of science and also use its results in conducting other research.
From where data/document is obtainable
Parisa hasannezhad:
Email: parisa.hasannezhad@yahoo.com
Address: Shaheed Rajaei Cardiovascular Medical and Research Center., Valiasr Ave., Niayesh Intersection., Tehran., Iran
What processes are involved for a request to access data/document
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.