The effect of self-care education on anxiety, self-efficacy and depression in adolescents with diabetes
Design
Clinical trial with control and intervention group for 100 patients
Settings and conduct
Research environment Nephrology ward of Hazrat Ali Asghar Hospital
Non-random assignment to intervention and control groups
Participants/Inclusion and exclusion criteria
Admission requirements:
Definitive diagnosis of diabetes
Age 12 to 18 yearss
Non-entry conditions: Non-cooperation of adolescents
Intervention groups
Intervention group: includes 4 sessions that are held once a week (4 weeks). Each session lasts 60 minutes. The afternoon intervention is performed from 2 to 6 pm in order to prevent interference in the program in the adolescent school classes. Meetings were held in groups of 4-6 participants. Training is done through lectures (using PowerPoint), questions and answers, group discussions and role plays. Session 1: Teaching adolescents about the nature of diabetes, prognosis, complications of diabetes. The second session includes teaching methods of disease control and the importance of appropriate daily activities and medication and their side effects. The third session includes training in diet and exercise activities and controlling the complications of diabetes and the correct method of insulin injection and daily blood sugar control. Session 4 Reviewing the contents of past sessions and increasing self-confidence in performing self-care.In the control group, routine care is performed .
Main outcome variables
Anxiety, self-efficacy and depression
General information
Reason for update
Acronym
دیابت
IRCT registration information
IRCT registration number:IRCT20141216020344N9
Registration date:2022-03-05, 1400/12/14
Registration timing:prospective
Last update:2022-03-05, 1400/12/14
Update count:0
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Hamidreza Khoshnezhad Ebrahimi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7787 2189
Email address
khoshnezhad.hr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education on anxiety, self-efficacy and depression in adolescents with diabetes
Public title
The effect of self-care education on anxiety, self-efficacy and depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 12 to 18 years
Definitive diagnosis of diabetes
Exclusion criteria:
Lack of cooperation of adolescents
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-01-26, 1400/11/06
Ethics committee reference number
IR.IUMS.REC.1400.1019
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention and immediately after intervention and one month after intervention
Method of measurement
Beck Anxiety Questionnaire
2
Description
Self-efficacy
Timepoint
Before intervention and immediately after intervention and one month after intervention
Method of measurement
General self-efficacy questionnaire
3
Description
Depression
Timepoint
Before intervention and immediately after intervention and one month after intervention
Method of measurement
Beck Depression Standard Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: includes 4 sessions that are held once a week (4 weeks). Each session lasts 60 minutes. The afternoon intervention is performed from 2 to 6 pm in order to prevent interference in the program in the adolescent school classes. Meetings were held in groups of 4-6 participants. Training is done through lectures (using PowerPoint), questions and answers, group discussions and role plays. Session 1: Teaching adolescents about the nature of diabetes, prognosis, complications of diabetes. The second session includes teaching methods of disease control and the importance of appropriate daily activities and medication and their side effects. The third session includes training in diet and exercise activities and controlling the complications of diabetes and the correct method of insulin injection and daily blood sugar control. Session 4 Reviewing the contents of past sessions and increasing self-confidence in performing self-care
Category
N/A
2
Description
Control group: In the control group, routine care is performed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Ali Asghar Hospital in Tehran
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 912 622 3904
Email
khoshnezhad.hr@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Keyvani
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@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
Dr Hamidreza Khoshnezhad Ebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@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
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
Data is encrypted in order to make the identity of individuals unidentifiable and confidential
When the data will become available and for how long
From the end of sampling to 6 months after the publication of the article
To whom data/document is available
University Ethics Committee, Project Arbitration Committee, Article Arbitration Committee and other researchers
Under which criteria data/document could be used
Perform systematic review or meta-analysis by mentioning the document
From where data/document is obtainable
Dr Hamidreza Khoshnezhad Ebrahimi Email address:khoshnezhad.hr@iums.ac.ir
What processes are involved for a request to access data/document
After submitting the application via academic email, we will provide the information files to the individuals within a maximum of one week.