Determine and compare the effectiveness of cognitive behavior training by peer and nurse on anxiety in patients with type-2 diabetes
Design
Clinical trials, control group and two intervention groups, based on counseling, randomized.
Settings and conduct
This study was performed on type 2 diabetic patients referred to the diabetes clinic in Gachsaran city. Patients were randomly divided into three groups: control, nurse intervention, and intervention by peer group.
Participants/Inclusion and exclusion criteria
Entry Criteria:
Type 2 diabetes
Duration of more than one year
The patient's score, according to the Hamilton Saxa Anxiety Inventory, is above 25
Literacy reading and writing
Inclination to study and have enough time to participate in the study
Not having physical and mental disabilities
Not having medical and pharmaceutical education
Lack of company background in the same study
The ability of the patient to take care of yourself
Exit criteria:
Patient withdrawal from the company for further research
More absenteeism in educational classes
Failure to complete the data collection tool
Intervention groups
An interventional study is a type of clinical trial. Patients were divided into two groups of intervention and one control group. One of the intervention groups was trained by the nurse and other group members.
Before training, Hamilton's Sachs 'anxiety questionnaire was answered by both the experimental and control groups and one week after the intervention (teaching cognitive behavioral model), the Hamilton Sachs' anxiety questionnaire was again run on both groups. The control group also receives diabetes routine clinic care, and the two other groups of Hamilton anxiety inventory are also filled in.
Main outcome variables
َََAnxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190211042681N1
Registration date:2019-06-01, 1398/03/11
Registration timing:retrospective
Last update:2019-06-01, 1398/03/11
Update count:0
Registration date
2019-06-01, 1398/03/11
Registrant information
Name
Ali Niknam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3222 5945
Email address
ali.niknam@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2019-05-25, 1398/03/04
Actual recruitment start date
2019-03-02, 1397/12/11
Actual recruitment end date
2019-05-21, 1398/02/31
Trial completion date
2019-05-21, 1398/02/31
Scientific title
Comparison of the effectiveness of cognitive behavioral modeling by peer and nurse on anxiety in type 2 diabetic patients .
Public title
Comparison of the effectiveness of cognitive behavioral modeling by peer and nurse on anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes with a history of over one year.
According to the Hamilton Sachs Anxiety Inventory, the patients' score is higher than 25.
Exclusion criteria:
Lack of reading and writing skills.
Unwillingness to participate in the study and not having enough time to participate in the study.
Disabling physical and mental illness.
Have medical and pharmaceutical education.
Having a company background in the same study.
Inability of the patient to take care of himself.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected in an accessible sampling form, demographic information form and tools for key variables will be completed by interviewing everyone. Subjects were assigned to three groups using permutation blocking method: training by nurse (25), training by peer (25) and control group (25 people).
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 Yasouj University of Medical Sciences
Street address
Shahid Motahari Blvd.
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2019-02-16, 1397/11/27
Ethics committee reference number
IR.yums.REC.1397.140
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety Score Based on Hamilton's Anxiety Rating Scale
Timepoint
The anxiety level of the patients is measured before intervention and one week after intervention
Method of measurement
Hamilton's Anxiety Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Control group: The control group receives only routine training related to its illness, including self-care, nutrition, exercise, and drug training.
Category
Prevention
2
Description
Intervention group 1: Trained by 4 nurses who have been trained in cognitive-behavioral behavioral techniques by psychologists for 16 sessions, they are trained in methodological behavioral techniques. Before the intervention and one week after the intervention, the rate Their anxiety is measured by Hamilton's Anxiety Rating Scale.
Category
Behavior
3
Description
Intervention group: Intervention group 2: Trained by 4 diabetic patients as "peers" previously trained by a psychologist in the cognitive-behavioral model, trained for 16 sessions of methodological behavioral techniques. Before the intervention and One week after the intervention, their anxiety levels are measured by Hamilton's Anxiety Rating Scale.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Gachsaran City
Full name of responsible person
Parvin Masnoei
Street address
Diabetes Clinic,Blaadian Street, Valiasr Blvd
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7531993111
Phone
+98 74 3222 4711
Email
parvin.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Ali Mousavi Zadeh
Street address
Yasouj University of Medical Sciences,Shahid Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
Health.epid@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Shir Ali Kharamin
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
3rd floor, Faculty of Medicine, next to Imam Sajjad Hospital، Coastal street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
sapootang@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Shir Ali Kharamin
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
3rd floor, Faculty of Medicine, next to Imam Sajjad Hospital، Coastal street