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The effectiveness of self-control training and communication skills on emotional regulation, perceived pain severity and self-care behaviors caused by nerve neuropathy in diabetic patients

Protocol summary

Study aim
The main goal of this study was to investigate the effectiveness of Self-Control Training and communication skills on emotional regulation, perceived pain Intensity and self-care behaviors caused by neuropathy in diabetic patients and sub goals based on variables separately by interventional methods
Design
The type of research was semi-experimental with pre-test and post-test with unequal control group. And in terms of data type, it was quantitative and methodologically, semi-experimental and purposeful, exploratory and in terms of outcome, was Applied
Settings and conduct
Individuals with diabetic neuropathy were selected at the Health Center of Mashhad, Shahid Ghodsi Health Center, self-control training and communication skills were performed on the basis of the above method in 10 sessions of 90 minutes and 15 from the experimental group, At the same time, 15 patients in the control group were pre-test. After doing the work, both post-test groups were taken. patients were provided with a researcher's own designs and the library was field-based
Participants/Inclusion and exclusion criteria
Conditions of entry; patients who have symptoms of neuropathy. patients with type 2 diabetes who have symptoms such as pain and paresthesia, pain in the limbs and leg burning during the night, patients with a duration of more than five years, people who are on the basis of a specific age found by the subject are present, conditions of non-entry; patients with type 1 diabetes, patients who have not filed a complaint at the Health Center patients not confirmed in the case of neuropathic symptoms
Intervention groups
15 subjects in experimental group that the effectiveness of self-control and communicative skills training was performed and 15 control subjects whose effectiveness was not performed.
Main outcome variables
Emotion regulation variables, perceived pain intensity and self-care behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171228038109N2
Registration date: 2018-06-10, 1397/03/20
Registration timing: retrospective

Last update: 2018-06-10, 1397/03/20
Update count: 0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Mahdi Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3869 1438
Email address
amirime@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-21, 1396/02/31
Expected recruitment end date
2017-07-04, 1396/04/13
Actual recruitment start date
2017-05-21, 1396/02/31
Actual recruitment end date
2017-07-04, 1396/04/13
Trial completion date
empty
Scientific title
The effectiveness of self-control training and communication skills on emotional regulation, perceived pain severity and self-care behaviors caused by nerve neuropathy in diabetic patients
Public title
The effect of self-control training and communication skills in nerve neuropathy of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been diagnosed with Neuropathy symptoms in the case Patients with type 2 diabetes most of the symptoms, such as nausea, paresthesia and pain in the limbs and needle fixation at night Patients of both sexes have a duration of more than five years Patients who are based on the age range specified by the subject Patients age 47 or older are allowed to enter the study because of diabetic neuropathy that occurs at an advanced age
Exclusion criteria:
Patients with type 1 diabetes Patients who do not have a ّfile at the Health center Patients whose symptoms of neuropathy have not been confirmed in the case Patients who are about 47 years of age or older are not allowed to enter the study because diabetic neuropathy does not occur at an early age
Age
From 47 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
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 Islamic Azad University, Science and Research Branch of Neyshabour
Street address
Research Area, Neyshabur, Razavi Khorasan Province
City
Neyshabur
Province
Razavi Khorasan
Postal code
9319797139
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
IR.IAV.NEYSHABUR.REC.1395.13

Health conditions studied

1

Description of health condition studied
Diabetic nerve neuropathy
ICD-10 code
E08.43
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy

Primary outcomes

1

Description
Emotion regulation, perceived pain intensity, self-care behaviors
Timepoint
The time interval at the beginning of the study on patients, pre-test (before intervention), 10 sessions 90 minutes and 30 days to post-test (after intervention)
Method of measurement
Emotion scoring score in the Graz Thrice disorders questionnaire, perceived pain intensity score in the McGill pain questionnaire, self-care behavior score questionnaire, self-care behavior questionnaire of Tubert and Glasgow diabetic patients

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: included 15 diabetic nerve neuropathy patients in Shahid Ghodsi Health Center in city of Mashhad. For 10 sessions of 90 minutes and for 1 month, self-control training and communication skills were performed on them
Category
Treatment - Devices

2

Description
Control group: The study included 15 diabetic neuropathic patients in Shahid Ghodsi Health Center in city of Mashhad. The effectiveness of self-control training and communication skills on these patients was not completed and only filled the questionnaires(Pre-test and post-test) at the same time as the intervention group, and there was an explanation for routine daily care in these patients.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center No.3 of Mashhad, Shahid Ghodsi Comprehensive Health Center
Full name of responsible person
Esmat Surgi
Street address
Next to the Blood Transfusion Organization, at the end of Sanabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 51 3844 0077
Email
behdasht3@mums.ac.ir
Web page address
http://behdasht3.mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khorasan Razavi Health Center
Full name of responsible person
Hamid Reza Bahrami
Street address
Health Center, End of Sanabad, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9185816212
Phone
+98 51 3841 5001
Fax
Email
health@mums.ac.ir
Web page address
http://health.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khorasan Razavi Health Center
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Health center number 3 of Mashhad city, Shahid Ghodsi Health Center
Full name of responsible person
Seyyedeh Mehri Boland Ashtian
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Next to the Blood Transfusion Organization, at the end of Sanabad, Mashhad
City
Mashhdd
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 513844007
Email
behdasht3@mums.ac.ir
Web page address
http://behdasht3.mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad Health Center No. 3, Shahid Ghodsi Health Center
Full name of responsible person
Maryam Keivan Jafari
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Next to the Blood Transfusion Organization, at the end of Sanabad, Mashhad
City
Mashhsd
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 513844007
Email
behdasht3@mums.ac.ir
Web page address
http://behdasht3.mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehdi Amiri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychology
Street address
Astan Qods Ave., Haramali Street, Avicenna Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51371127017
Email
sina@mums.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
Only part of the data, such as Information on the main outcome, or the like, can be shared
When the data will become available and for how long
Start the access period from 1398
To whom data/document is available
Data is available for Researchers working in Academia and Academia
Under which criteria data/document could be used
In Patients who develop diabetic neuropathy and type 2 diabetes, they are affected by conditions and symptoms that damage their nerve and the involvement of a nerve in a region. data Analysis was analyzed using descriptive statistics (mean and standard deviation) and inferential statistics (multivariate covariance test).
From where data/document is obtainable
Mashhad Health Center No. 3, to the website: http://behdasht3.mums.ac.ir, tel: 051337634007 Address: Boulevard Khayyam, Boulevard Ershad 8, St.Petersburg, on message 6, and Shaheed Ghodsi Health Center, at the end of Sanabad Street, along with the blood transfusion organization, the diabetes education unit, Mrs. Saydeh Mehri Alishi and Ms. Maryam Keivan Jafari. Address: End of Sanabad Street, next to the blood transfusion organization
What processes are involved for a request to access data/document
The Research and research done according to the Intervention method and test hypotheses that were performed during the specified period are made.from defense date to 31/4/1396
Comments
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