Evaluation of the effects of mindfulness meditation on glycemic control and mental health in patients with diabetes type II , Imam Ali City Comprehensive Health Center , 2018
The Effect of Mindfulness Based Stress Management on Glycemic Control and Mental Health in Patients with type 2 Diabetes Mellitus
Design
randomized controlled clinical trial
Settings and conduct
This study will be carried out on patients with diabetes mellitus type 2 referred to Imam Ali’s comprehensive health care center (Isfahan city) in 2019
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diabetes Mellitus with the approval of a physician, having a health record in the health center, Age between 30-59 years, HbA1c ranged between 7-9%, History of diabetes for at least 6 months, informed consent. Exclusion criteria: acute psychological disorders, Chronic diseases such as cancer or any other serious medical condition, pregnancy and lactation, alcohol and substance abuse, end organ damage caused by diabetes, psychological treatment in the past year.
Intervention groups
The intervention group will be taught 8 sessions (each session 2 hours) once a week, by an expert psychologist and will then perform home exercises for 4 weeks and report the homework weekly. The control group is under the routine care of the health system.
Main outcome variables
Anxiety, Depression and Stress score
Glycemic indexes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190813044527N1
Registration date:2020-01-29, 1398/11/09
Registration timing:retrospective
Last update:2020-01-29, 1398/11/09
Update count:0
Registration date
2020-01-29, 1398/11/09
Registrant information
Name
omid nikkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3833 2114
Email address
omid.nik71@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2018-12-22, 1397/10/01
Trial completion date
2019-04-19, 1398/01/30
Scientific title
Evaluation of the effects of mindfulness meditation on glycemic control and mental health in patients with diabetes type II , Imam Ali City Comprehensive Health Center , 2018
Public title
The Effect of Mindfulness Based Stress Management on Glycemic Control and Mental Health in Patients with Diabetes Mellitus
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes Mellitus with the approval of a physician
having a health record in the health center
Age between 30-59 years
HbA1c ranged between 7-9%
History of diabetes for at least 6 months
informed consent
Exclusion criteria:
acute psychological disorders
Chronic diseases such as cancer or any other serious medical condition
pregnancy and lactation
alcohol and substance abuse
end organ damage caused by diabetes
psychological treatment in the past year
Age
From 30 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Actual sample size reached:
108
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 108 diabetic patients with inclusion criteria will be selected by convenient sampling from the Imam Ali Comprehensive Health care Center in Isfahan. All participants will be invited to an introduction session, and a code will be assigned to each patient in front of their name and contact number. These codes will be randomly divided into two groups of 54 people using random allocation software v. 2.0 developed by Mahmood Saghaei and downloaded for free from Google. Then, based on the resulting list and contact numbers provided during the introduction session, we will contact with the intervention group patients, and the necessary coordination will be done.
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2018-12-12, 1397/09/21
Ethics committee reference number
IR.MUI.MED.REC.1397.165
Health conditions studied
1
Description of health condition studied
DIABETES
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Anxiety, Depression and Stress
Timepoint
Beginning of the study and 13 weeks after the intervention
Method of measurement
DASS21 questionnaire
2
Description
Fasting Blood Sugar
Timepoint
Beginning of the study and 13 weeks after the intervention
Method of measurement
fasting venous blood sample
3
Description
HbA1c
Timepoint
Beginning of the study and 13 weeks after the intervention
Method of measurement
fasting venous blood sample
Secondary outcomes
1
Description
sleep quality
Timepoint
before and 13 weeks after the intervention
Method of measurement
Pittsburgh Sleep Quality questionnaire
Intervention groups
1
Description
Intervention group: Eight 2-hour sessions once a week are taught by an expert psychologist, followed by 4 weeks homework which will be weekly reported by the patient. The topics of these sessions include explanations of mindfulness, physical activity and yoga exercises, receiving feedback and answering the questions, breathing exercises, and sleep hygiene education.
Category
Other
2
Description
Control group: This group is under routine care based on national guidelines for diabetes mellitus management
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Urban Comprehensive Health Care Center
Full name of responsible person
Dr Anahita Babak
Street address
West Toosi St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81649 69459
Phone
+98 31 3661 7371
Email
babakanahita@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo Javanmard
Street address
Vice-Chancellery for Research and Technology, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8092
Fax
+98 31 3669 2174
Email
sh.haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Anahita Babak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences , Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8112
Email
babakanahita@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Anahita Babak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8112
Email
babakanahita@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Anahita Babak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8112
Email
babakanahita@yahoo.com
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
Whole data will be available
When the data will become available and for how long
Immediately after publishing manuscript
To whom data/document is available
To whom is in need to this data
Under which criteria data/document could be used
Email to Dr Anahita Babak, Email: babakanahita@yahoo.com
From where data/document is obtainable
Dr Anahita Babak Email: babakanahita@yahoo.com
What processes are involved for a request to access data/document