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The impact of resiliency skills on self-efficacy in patients with type II diabetes

Protocol summary

Summary
This study is a randomized clinical trial on 150 patients with type II diabetes were referred to Motahari Clinic in Shiraz . Patients were selected through convenience sampling. Then randomly divided into two groups of intervention and control. Resilience Scale (CD-RISC) and self diabetes (DMSES), before the intervention, immediately after and one month after the intervention in both groups were completed. Program in the experimental group: Six sessions for a month and a half, two hours was carried out. Training topics include: Self-awareness, coping skills with negative mood and depression, anger management skills, stress management and problem solving skills. Patients in the control group received routine training. Inclusion criteria: Diagnosis of type II diabetes by an endocrinologist, aged 30 to 80 years, resiliency score less than 52, the middle and lower self-efficacy, residing in Shiraz. Exclusion criteria: Presence of mental disorders and mental retardation, lack of participation in more than two sessions, attend the same classes Educational

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022726790N1
Registration date: 2017-03-03, 1395/12/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-03, 1395/12/13
Registrant information
Name
Zahra Asadabadi por
Name of organization / entity
Fatemeh School of Nursing & Midwifery Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 71 4440 7001
Email address
stud2400052808@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of resiliency skills on self-efficacy in patients with type II diabetes
Public title
Resilience impact on diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of type II diabetes by an endocrinologist, aged 30 to 80 years, resiliency score less than 52, the middle and lower self-efficacy, residing in Shiraz. Exclusion criteria: Presence of mental disorders and mental retardation, lack of participation in more than two sessions, attend the same classes Educational
Age
From 30 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the method of randomization (table of random numbers) have been selected.

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Motahari Clinic, Namaz Square, Shiraz
City
Shiraz
Postal code
Approval date
2016-01-10, 1394/10/20
Ethics committee reference number
IR.SUMS.REC.1394.172

Health conditions studied

1

Description of health condition studied
Type II diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Self- efficacy
Timepoint
Before intervention, immediately after the intervention, one month after the intervention.
Method of measurement
Diabetes Management Self- efficacy Scale

Secondary outcomes

1

Description
Resilience
Timepoint
Before intervention, immediately after the intervention, one month after the intervention.
Method of measurement
Conner- Davidson Resilience scale

Intervention groups

1

Description
Program in the experimental group, Six sessions for a month and a half, two hours was carried out. Training topics include: Self-awareness, coping skills with negative mood and depression, anger management skills, stress management and problem solving skills
Category
Behavior

2

Description
The control group receive training routine
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic; Motahari Clinic;
Full name of responsible person
Phd Camellia Torabizadeh
Street address
Diabetes Clinic; Motahari Clinic; Namaz Square; Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Vice President of Research, Floor 7, Headquarters of Shiraz University of Medical Science, Zand Street, Shiraz
City
Shiraz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Fatemeh School of Nursing & Midwifery Shiraz
Full name of responsible person
Zahra Asadabadi por
Position
Nursing student
Other areas of specialty/work
Street address
Fatemeh School of Nursing & Midwifery Shiraz, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Postal code
73971-71734
Phone
+98 71 4440 7001
Fax
0
Email
Stud2400052808@sums.ac.ir
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemeh School of Nursing & Midwifery Shiraz
Full name of responsible person
Dr Camellia Torabizadeh
Position
PhD
Other areas of specialty/work
Street address
Fatemeh School of Nursing & Midwifery Shiraz, Zand Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
Torabik@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing Fatima
Full name of responsible person
Zahra Asadabadi por
Position
Nursing student
Other areas of specialty/work
Street address
Fatemeh School of Nursing & Midwifery Shiraz, Zand Street, Shiraz
City
Shiraz
Postal code
7397171734
Phone
+98 71 4440 7001
Fax
Email
Stud2400052808@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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