The Effect of Psychological Educational intervention with progressive muscle relaxation on Depression ,Anxiety,stress, serum Cortisol and HB A1C level in Type 2 diabetic patients
Determining the Effectiveness of Psychological Education on Depression, Anxiety, Stress, Serum Cortisol Level and HBA1C Level in Type 2 Diabetic Patients
Design
People who have a case in diabetes clinic are randomly selected.
Settings and conduct
In Clinic of Diabetes in Rafsanjan City.Questionnaires were provided to two groups of patients and two to two days and performed Hba1c and cortisol tests.Hold the class for the case group, repeat the test and the questionnaire immediately and the next month for both groups.
Participants/Inclusion and exclusion criteria
Login to the study:
1. Type II diabetes mellitus
2 between 20-50 years
3. Minimum cycles
4. No participation in yoga classes, meditation, prayers, specific sports activities, lifestyle and adaptation strategies in the past six months.
5. Iranian 6. No accidents in the last 6 months. 7. No use of corticosteroids
Exit:
1. Apply to other Endocrine Disorders
2. Severe diabetes mellitus
3. Not attending two training sessions.
Intervention groups
The samples were randomly divided into test and control groups according to the entrance and exit criteria. Both groups completed a demographic questionnaire and a standardized questionnaire (DASS21) including depression, anxiety, stress. Before the beginning of the study, the endocrinologist and psychologist will be interviewed and examined by the psychologist. 12 training sessions will be held. After the training month, two questionnaires and Hba1c and cortisol tests are checked. In the control group, there is no training alone.
Main outcome variables
Mean score of depression, stress anxiety.Hb a1c، cortisol and ...
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180304038936N4
Registration date:2018-09-10, 1397/06/19
Registration timing:retrospective
Last update:2018-09-10, 1397/06/19
Update count:0
Registration date
2018-09-10, 1397/06/19
Registrant information
Name
Ahmadreza Sayadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
a.sayadi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-28, 1397/02/08
Expected recruitment end date
2018-07-30, 1397/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Psychological Educational intervention with progressive muscle relaxation on Depression ,Anxiety,stress, serum Cortisol and HB A1C level in Type 2 diabetic patients
Public title
The effect of Psychologicaleducation on diabetes, stress, anxiety and depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Registration of Type II Diabetes Mellitus in the medical records of the Diabetes Clinic
2.Lack of injecting insulin.
3.Having informed consent to participate in the study.
4.Not having a history of mental illness
5.Do not use herbal remedies that affect blood sugar levels.
6.Do Not Advanced Neuropathy.
7.Lack of history of physical illness simultaneously
8. At least one year of diabetes
9.Lack of alcohol and drug use
10. between 50-20 years
11.Minimum cycle education
12. Non-use of psychotropic drugs and cognitive therapies during the study
13.Non-attendance at yoga classes, meditation, pacifism, special sports activities, lifestyle and adaptation strategies in the past six months
14.Lack of hearing and speech problems
15.Patients undergoing treatment and without changes to the drug during the study period
16.Iranian nationality
17.No incident in the last 6 months
18.Do not use corticosteroids drugs
Exclusion criteria:
1.It is not participating in training classes
2.Dissatisfaction with continued collaboration during the study period
3.Depending on other endocrine disorders
4.Cancel the continuation of participation in the workshop
5.Changes in the general condition of the patient associated with changes in blood glucose levels
6.ComplicationsSevere diabetes mellitus
7.Not participating in two training sessions
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
30
Each person is included in the study as a separate sample.
Randomization (investigator's opinion)
Randomized
Randomization description
Of the cases in the Diabetes Clinic, 60 out of 5,000 randomly selected cases (women and men) were randomly selected based on entry and exit criteria, and divided randomly into two groups of control and control as random numbers.
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 Rafsanjan University of Medical Sciences
Street address
Office of Medical University Blvd Imam Ali
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.RUMS.REC.1397.019
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08.0
ICD-10 code description
Diabetes mellitus due to underlying condition with hyperosmolarity
Primary outcomes
1
Description
Study of Depression
Timepoint
Check the variables before, immediately after and three months after the intervention
Method of measurement
DASS21 questionnaire
2
Description
Check the amount of stress
Timepoint
Before intervention immediately after intervention, and three months after intervention
Method of measurement
DASS21 questionnaire
3
Description
Anxiety Survey
Timepoint
Before intervention immediately after intervention, and three months after intervention
Method of measurement
DASS21 questionnaire
4
Description
Study of HBA1c
Timepoint
Before intervention immediately after intervention, and three months after intervention
Method of measurement
blood test
5
Description
Cortisol levels
Timepoint
Before intervention immediately after intervention, and three months after intervention
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
For the intervention group, 12 sessions of psychological training, along with progressive muscle relaxation, are performed every twoSessions each week.
Category
Rehabilitation
2
Description
Control group: Complete the questionnaire and blood test. To be associated with posting the training sessions after the intervention in the intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes ClinicAli ibn Abi Talib.Rafsanjan
Full name of responsible person
Aezam Mirmahdi
Street address
Ali ibn Abi Talib Ayatollah Saeedi Square Taleghani Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717937455
Phone
+98 34 3428 0001
Email
aliebn@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Zare
Street address
Head office ofMedical university Blvd Imam Ali
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0086
Email
a.sayadi@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
90
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Aezam Mirmahdi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hospital Ali ibn Abi Talib Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717777363
Phone
+98 34 3433 0144
Email
aeza8690@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Aezam Mirmahdi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hospital Ali ibn Abi Talib Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717777363
Phone
+98 34 3428 0003
Email
a.sayadi@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Aezam Mirmahdi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hospital Ali ibn Abi Talib Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717777363
Phone
+98 34 3428 0003
Email
a.sayadi@rums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
How to do work and shareable results.
When the data will become available and for how long
Probably starting to access 3 months after printing results.
To whom data/document is available
Probably starting to access 3 months after printing results
Under which criteria data/document could be used
If the manufacturer needs documentation, it will be provided.
From where data/document is obtainable
I will be at the service of other people by email or telephone number.
What processes are involved for a request to access data/document