The aim of this study was to investigate the effect of self-care program based on Orem's self-care model on quality of life in adolescents with type 1 diabetes referred to the 17 Shahrivar Hospital in Rasht.
Design
The present study is a quasi-experimental research with a control group and sampling will be done by convenience method.
Settings and conduct
The present study will be carried out in 17 Shahrivar hospital of Rasht. In this study, adolescents will be allocated into two groups of intervention and control and the intervention group will be provided with an educational program, while the control group will not receive. The quality of life in both groups will be measured after the intervention.
Participants/Inclusion and exclusion criteria
The inclusion criteria: all adolescents aged 11 to 18 years old admitted to17 Shahrivar Hospital in Rasht.
Exclusion criteria: existence of any psychological disorders in adolescents.
Intervention groups
There are two groups of intervention and control. In intervention group educational training base on Orem's theory provide and in control group educational training do not provide.
Main outcome variables
Quality of life in adolescents
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171008036651N3
Registration date:2019-03-05, 1397/12/14
Registration timing:prospective
Last update:2019-03-05, 1397/12/14
Update count:0
Registration date
2019-03-05, 1397/12/14
Registrant information
Name
Yasaman Yaghobi
Name of organization / entity
Guilan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 6046
Email address
yasamanyaghobi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-20, 1398/01/31
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the Impact of Orem’s Self-Care Model on the Quality of Life in Adolescent with Diabetes Type 1
Public title
Survey the Impact of Orem’s Self-Care Model on the Quality of Life in Adolescent with Diabetes Type 1
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic adolescents aged 11 to 18 years old who will be hospitalized in the 17-Shahrivar hospital of Rasht.
Exclusion criteria:
Psychological disorders in adolescents
Age
From 11 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
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
Ethica committee of Guilan University of Medical Sciences
Street address
Guilan University Of Medical Sciences, Iran Radiator Building, Imam Khomeini Blv, Rasht
City
Rasht
Province
Guilan
Postal code
3984141469
Approval date
2019-01-14, 1397/10/24
Ethics committee reference number
IR.GUMS.REC.1397.403
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08.10
ICD-10 code description
Diabetes mellitus due to underlying condition with ketoacidosis without coma
Primary outcomes
1
Description
Quality of life score in adolescents
Timepoint
The quality of life in adolescents will be measured immediately and two months after the intervention in the two groups.
Method of measurement
The quality of life in adolescents will be measured by the Weber quality of life questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, the Orem-based educational program will be presented by the researcher in six sessions and at the end of the training sessions and two months later, the quality of life will be measured.
Category
Lifestyle
2
Description
In the control group, the educational program will not be provided and the quality of life will be measured in the same way as the intervention group at the end of the training sessions and two months later.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Medical and Education Center
Full name of responsible person
Somaye Pouy
Street address
Yakhsazi Square, Hamidian Town, Rasht
City
Rasht
Province
Guilan
Postal code
4148835132
Phone
+98 13 3323 8307
Email
somayepouy@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Doctor Shadman Nemati
Street address
Guilan University Of Medical Sciences, Iran Radiator Building, Imam Khomeini Blv, Rasht
City
Rasht
Province
Guilan
Postal code
416351873
Phone
+98 13 3333 6394
Email
nemati@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Somaye Pouy
Position
Master of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yakhsazi Square, Hamidian Town, Rasht
City
Rasht
Province
Guilan
Postal code
4148835132
Phone
+98 13 3355 5056
Email
somayepouy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Doctor Yasaman Yaghobi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Nursing and Midwifery Faculty, Yakhsazi Square, Rasht
City
Rasht
Province
Guilan
Postal code
4148835132
Phone
+98 13 3355 5056
Email
yasamanyaghobi@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Somaye Pouy
Position
Master of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yakhsazi Square, Hamidian Town, Rasht.
City
Rasht
Province
Guilan
Postal code
4148835132
Phone
+98 13 3355 5056
Email
somayepouy@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of the information of the participants and do not starting sampling, we do not currently decide on the release of individual information.