The aim of this randomized controlled trial was to examine the effectiveness of self-efficacy- based intervention on self-care level among diabetic adolescents. The study was conducted in the Children’s Hospital of Rasht. The study population,aged between 11 and 20, consisted of 50 eligible adolescents suffering from Type I Diabetes and referred to the clinic. Using a Randomized Block Design, which consisted of both genders who assigned into the experimental and control groups. After signing an informed consent , the participants filled out questionnaires specifically designed for these adolescents regarding demographic data, self-efficacy and self-care . Before the implementation of the desired intervention, the researcher determined the mean score of self-efficacy and self-care. The participants in the experimental group received intervention designed to enhance self-efficacy based on Bandura’s theory. The intervention consisted of 6 sessions (2 hours) each week, for two weeks in addition to the routine care. In two episodes, immediately after the completion of the intervention and three months later, all participants filled out the questionnaire again. Additionally, the researcher measured and recorded glycosylated hemoglobin (HbA1c) before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201055499N2
Registration date:2013-08-02, 1392/05/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-02, 1392/05/11
Registrant information
Name
Seyedeh Noushaz MirHaghjou
Name of organization / entity
Nursing and Midwifery Faculty, Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 6046
Email address
n_haghjou@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Office of the Vice Chancellor for Research , Guilan University of Medical Sciences
Expected recruitment start date
2012-01-02, 1390/10/12
Expected recruitment end date
2012-08-10, 1391/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of self-efficacy-based intervention on self-care level in diabetic adolescents
Public title
The effectiveness of self-efficacy-based intervention on self-care level in diabetic adolescents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 11 and 20 ; being single; diabetic diagnosis at least for past two months.
Exclusion criteria: having hemoglobinopathy, anemia, reticulocytosis and uremia during study
Age
From 11 years old to 20 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
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 vice chancellor for research , Guilan University of Medical Sciences
Street address
Vice chancellor for research , Opposite of Alzahra hospital, Shahid Siadati street, Namjoo Avenue, Rasht Rasht Guilan Iran, Islamic Republic Of 68164-41446
Prior to the intervention,Immediately and after the intervention and after three months
Method of measurement
Diabetic adolescents self-care questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Case group: After signing an informed consent, the participants filled out questionnaires specifically designed for these adolescents regarding demographic data, self-efficacy and self-care in relation to their diagnoses, in the presence of the researcher. Before the implementation of the desired intervention, the researcher determined the mean score of self-efficacy and self-care. The participants in the experimental group received intervention designed to enhance self-efficacy based on Bandura’s theory. The intervention involved three sessions each week-each session lasting 2 hours-for the total duration of two weeks, in addition to the routine care. Intervention was directed at self-efficacy enhancement according to Bandura's theory. The intervention involved preparing the appropriate practice conditions, using other patients' successful experiences, and getting and building on feedback. In two episodes, immediately after the completion of the intervention and three months later, all participants filled out the questionnaire again. Additionally, the researcher measured and recorded glycosylated hemoglobin (HbA1c) before and after the intervention.
Category
Other
2
Description
Control group: researcher did not any intervention in this group. Both groups received routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Hospital
Full name of responsible person
Seyedeh Noshaz Mirhaghjoo
Street address
Children’s Hospital, Across from the Azodi Stadium, Namjoo Avenue, Rasht
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Office of the Vice chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Dr Abdolrasol Sobhani
Street address
Alzahra Hospital, Shahid Siadati Street, Namjoo Avenue, Rasht, Guilan, The Islamic Republic of Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Office of the Vice chancellor for research, Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti Nursing and Midwifery College
Full name of responsible person
Seyedeh Noshaz Mirhaghjou
Position
Vice chancellor for education
Other areas of specialty/work
Street address
Shahid Beheshti Nursing and Midwifery College, Daneshjoo Boulevard, Shahid Beheshti Highway, Rasht, Guilan, The Islamic Republic of Iran
City
Rasht
Postal code
41469-39814
Phone
+98 13 1555 6046
Fax
Email
n_haghjou@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Nursing and Midwifery College
Full name of responsible person
Seyedeh Noshaz Mirhaghjou
Position
Vice chancellor for education
Other areas of specialty/work
Street address
Shahid Beheshti Nursing and Midwifery College, Daneshjoo Boulevard, Shahid Beheshti Highway, Rasht, Guilan, The Islamic Republic of Iran
City
Rasht
Postal code
39814-41469
Phone
+98 13 1555 6046
Fax
+98 13 1555 0097
Email
n_haghjou@gums.ac.ir; n.haghjou@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti Nursing and Midwifery College
Full name of responsible person
Seyedeh Noshaz Mirhaghjou
Position
Vice chancellor for education
Other areas of specialty/work
Street address
Shahid Beheshti Nursing and Midwifery College, Daneshjoo Boulevard, Shahid Beheshti Highway, Rasht, Guilan, The Islamic Republic of Iran
City
Rasht
Postal code
39814-41469
Phone
+98 13 1555 6046
Fax
+98 13 1555 0097
Email
n_haghjou@gums.ac.ir; n.haghjou@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)