The aim of this study was to evaluate the effect of coping skills training on self-efficacy, depression, anxiety, stress and quality of life of adolescents with diabetes type 1. A randomized controlled trial was carried out in the diabetic clinic in Emam Reaz Institute affiliated to Shiraz University of Medical Sciences. The adolescents with diabetes type 1 (n = 100) were included in two groups: a coping skills training group (n = 50) and a control group (n = 50). Coping skills training was done in intervention groups for eight sessions, twice a week for 4 weeks. Self-efficacy, depression, anxiety, stress and quality of life were assessed in both groups at baseline and 8 weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050113690N4
Registration date:2015-05-16, 1394/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Masoume Rambod
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4258
Email address
rambodm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-08-22, 1393/05/31
Expected recruitment end date
2015-05-01, 1394/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of coping skills training on diabetic adolescences self-efficacy, depression, anxiety, stress and quality of life
Public title
Effect of coping skills training on diabetic
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria of this study will be having diabetes type І, being 12-18 years old, having been diagnosed of diabetes for at least the previous 3 months, and being oriented and alert. The exclusion criteria of this study would be included training in six months ago or current participation in any coping skills training.
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)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University of Medical Sciences
Street address
71345-1978, 7th floor, shiraz university of medical sciences, beside the Red-Crescent building, Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2014-05-23, 1393/03/02
Ethics committee reference number
93-01-86-7217
Health conditions studied
1
Description of health condition studied
diabetes type 1
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Self-efficacy
Timepoint
First day of study and 8th week
Method of measurement
General self-efficacy
Secondary outcomes
1
Description
Depression, anxiety, and stress
Timepoint
First day and 8th week
Method of measurement
Depression, Anxiety, and Stress Scales (DASS)
2
Description
Quality of life
Timepoint
First day of study and 8th week
Method of measurement
War & Sherbon SF- 36
Intervention groups
1
Description
Intervention: Coping skills training (CST) was performed by lecture, question and discussion, and role playing. In the lecturer, power points were prepared. The intervention was performed by a MS of pediatric nursing who has been experiencing in the field of diabetes for 15 years.
The contents CST were as follow:
Session 1, “Introduction”: at the first session, the interventionist introduces herself to the participants and then subjects introduce themselves. Then the content of the CST was given to them.
Session 2, “Recognizing the disease”: In this session, information about diabetes disease, etiology, symptom, and treatment were given to the adolescents.
Session 3, “Principles of self-care”: In this session, teaching about effect of disease on adolescents, and self-care (nutrition, physical activity, prevention of infection, vaccination, drug, and . . .) were given.
Session 4, “Stress management”: In this session, the subjects expressed their feelings about diabetes, symptoms, complication, and their fear and anxiety. Moreover, information about stress’ psych-somatic symptoms, factors which increasing stress, and strategies to decrease it and methods of increasing self-esteem were described for subjects.
Session 5, “Coping strategies”: in this session, interventionist described about coping and effective and ineffective coping strategies.
Session 6: “Relaxation Techniques”: in this session the importance of relaxation techniques in decreasing stress and improving coping were discussed. Interventionist trained the subjects to do breathing exercises and muscle relaxation, two times a day (9AM and 5 PM).
Session 7, “Problem Solving”: In this session, the interventionist explained the concept of problem, problem solving, problem-solving stages and the significance of problem solving in managing and coping with stress.
Session 8, “Assessment” In this session, the CST and the interventionist are evaluated. Moreover, answers to adolescents’ questions were given.
Category
Behavior
2
Description
control: The participant in control group received the routine care of clinic without any interventions.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetic clinic in Emam Reaz Institute affiliated to Shiraz University of Medical Sciences
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Skandari
Street address
71345-1978,7th floor, Shiraz University of Medical Sciences, beside the Red-Crescent building, Zand Ave, Shiraz.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shiraz 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
Shiraz University of Medical Sciencese
Full name of responsible person
Masoume Rambod
Position
MS and PhD Candidate
Other areas of specialty/work
Street address
Nursing and Midwifery of Shiraz University of Medical Sciences, Namazee Sque, Zand Street, Shiraz
City
Shiraz
Postal code
Phone
00
Fax
Email
rambodma@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Edraki
Position
MS
Other areas of specialty/work
Street address
Nursing and Midwifery of Shiraz University of Medical Sciences, Namazee Sque, Zand Street, Shiraz
City
Shiraz
Postal code
Phone
00
Fax
Email
mitraedraki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoume Rambod
Position
Other areas of specialty/work
Street address
Nursing and Midwifery University, Namazee Sque, Zand Street, Shiraz
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)