Objectives: Diabetes is a chronic and lifelong disease and have many physical and psychological complications that affect the quality of life. This study aimed to determine the effectiveness of Mindfulness based stress reduction on quality of life in patients with type 2 diabetes.
Design: This quasi-experimental study has a pretest-posttest design with control group.
Participants including major eligibility criteria: The study population include 30 diabetic patients, randomly divided into two, the study and control groups. Type 2 diabetes was the main criterion for entering this study.
Setting and conduct: We used Waren & Sherbourne quality of life questionnaire (SF-36). Eight sessions of Mindfulness based stress reduction group training conducted in eight weeks for study group while the control group received no intervention. Both groups completed the (SF-36) before and after the intervention.
Intervention: Eight sessions of Mindfulness based stress reduction group training were conducted in eight weeks for study group while the control group received no intervention.
Measures: Quality of life was the main variable in this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100736572N2
Registration date:2017-10-16, 1396/07/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-16, 1396/07/24
Registrant information
Name
Hamid Kharatzadeh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1548
Email address
h_kharatzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of mindfulness based stress reduction on quality of life of patients with type 2 diabetes mellitus
Public title
Effect of mindfulness on quality of life of diabetic patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Having type 2 diabetes; More than 18 years old; No psychological intervention has been received since the diagnosis of the disease; The absence of an acute or chronic medical condition that causes problems in tolerating long sessions; No severe psychiatric illnesses, such as psychotic disorders; No substance abuse or addiction.
Exclusion criteria: Severe complications of diabetes leading to hospitalization; Missing more than two sessions; The occurrence of major stresses due to unforeseen events.
Age
From 18 years old to 110 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Koodakyar St, Tehran
City
Tehran
Postal code
Approval date
2016-08-16, 1395/05/26
Ethics committee reference number
IR.SBMU.MSP.REC.1395.184
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E-10,E-11,
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Quality of life
Timepoint
Pre and post test.
Method of measurement
Waren & Sherbourne quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group: Mindfulness based stress reduction.
Mindfulness based stress reduction is a training program using a variety of mindfulness practices, both formal and informal. Participants are required to practice mindfulness as homework for a total 45 minutes, 6 days each week during the course of the program.
Category
Other
2
Description
Control group: No action.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Diabetes Charity Center
Full name of responsible person
Mr. Ahmad Nilforoushan
Street address
Isfahan Diabetes Charity Center, Lahore Street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mrs. Memar
Street address
Shahid Beheshti University of Medical Sciences, Koodakyar St, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamid Kharatzadeh
Position
MSc
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Koodakyar St, Tehran
City
Tehran
Postal code
Phone
+98 21 2303 1548
Fax
Email
Hkharratzade@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Hasan Davazdah Emamy
Position
PhD
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Koodakyar St, Tehran
City
Tehran
Postal code
Phone
+98 21 2303 1548
Fax
Email
emami@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamid Kharatzadeh
Position
MCs
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Koodakyar St, Tehran
City
Tehran
Postal code
Phone
+98 21 2303 1548
Fax
Email
Hkharatzadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)