Comparative investigating the effect of relaxation and meditation techniques on quality of life in patients with coronary artery disease referred to the outpatient clinic
Comparison the effect of relaxation and meditation techniques on quality of life in patients with coronary artery disease
Design
Randomized, parallel group clinical trial
Settings and conduct
Study population are patients with coronary artery disease referred to outpatient clinics of Rafsanjan University of Medical Sciences. Sample size estimated 100 based on previous studies. Samples will allocated two groups of relaxation and meditation using random number table. Exercises will educated to patients by researcher. In relaxation group, patients undergo relaxation exercises twice a day (morning and night), each time for 15 minutes. In meditation group, patients undergo meditation exercises twice a day (morning and night), each time for 15 minutes.
Participants/Inclusion and exclusion criteria
Diagnosis of coronary artery disease (based on angiography), complete consciousness, history of admission to the CCU, ability to understand and speak persian and informed consent for participate in the study are inclusion criteria. History of mental illness, using of psychiatric drugs and heart failure in the last 6 weeks are exclusion criteria.
Intervention groups
Relaxation group: In this group, patients undergo relaxation exercises twice a day (morning and night), each time for 15 minutes.
Meditation group: In this group, patients undergo meditation exercises twice a day (morning and night), each time for 15 minutes.
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150519022320N14
Registration date:2018-10-28, 1397/08/06
Registration timing:registered_while_recruiting
Last update:2018-10-28, 1397/08/06
Update count:0
Registration date
2018-10-28, 1397/08/06
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigating the effect of relaxation and meditation techniques on quality of life in patients with coronary artery disease referred to the outpatient clinic
Public title
Comparative investigating the effect of relaxation and meditation techniques on quality of life in patients with coronary artery disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of coronary artery disease (based on angiography)
Complete consciousness
History of admission to the CCU.
Ability to understand and speak Persian
Informed consent for participate in study
Exclusion criteria:
History of mental illness
History of using psychiatric drugs
Heart failure in the last 6 weeks
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization based on random number table: In this method, first a list of patients will provide based on inclusion and exclusion criteria, then patients are divided into two groups of relaxation and meditation using random number table.
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
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-06-27, 1397/04/06
Ethics committee reference number
IR.RUMS.REC.1397.071
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease
Primary outcomes
1
Description
Mean score of quality of life
Timepoint
Before the intervention, one month after the intervention, two months after the intervention
Method of measurement
Minnesota quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Relaxation : In this group, patients undergo relaxation exercises twice a day (morning and night), each time for 15 minutes.
Category
Lifestyle
2
Description
Meditation: In this group, patients undergo meditation exercises twice a day (morning and night), each time for 15 minutes.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart clinic
Full name of responsible person
Mahboobeh Kafizadeh
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
kafizadehm@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
vcrt@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
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Ravari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
Ravary4776@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Ravari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
Ravary4776@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayebeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
t.mirzaei@rums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available