Protocol summary

Summary
The purpose of this study is The effectiveness of group mindfulness training on reducing symptoms of psychopathology and electrocardiographic changes in patients with coronary heart disease. in this study participated 22 men suffering from coronary heart disease that Not taking any psychiatric drug, with age range between 30 to 60-year and Third Degree Level up that were selected to the consecutive sampling and were assigned randomly into an experimental group and a control group. .group mindfulness training Was formed 8 sessions (4 weeks, each week 2 session being 2 hours) for experimental group. anxiety, depression, hostility, and electrocardiographic changes were compared in the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012103011323N1
Registration date: 2013-01-28, 1391/11/09
Registration timing: na

Last update:
Update count: 0
Registration date
2013-01-28, 1391/11/09
Registrant information
Name
Mahsa Jahangirpour
Name of organization / entity
University of Guilan
Country
Iran (Islamic Republic of)
Phone
+98 13 2622 2708
Email address
mjahangirpour@yahoo.com
Recruitment status
Not enough for processing
Funding source
Faculty of Literature and Humanities, University of Guilan, Guilan Province
Expected recruitment start date
2011-07-05, 1390/04/14
Expected recruitment end date
2011-06-11, 1390/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of group mindfulness training on reducing symptoms of psychopathology and electrocardiographic changes in patients with coronary heart disease
Public title
Effect of mindfulness in reducing depression, anxiety and aggression in patients with heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
( Inclusion criteria: Gender: Male; having symptoms of coronary heart disease based on Cardiac Doctor checkup And angiographic results ; age range between 30 to 60-year; Third Degree Level up. Exclusion criteria: patients with neurological and physical problems such as Kidney disease coupled with heart disease; patients in addition with heart disease facing Chronic pain from Reins, rheumatism Etc; Patients were used from psychiatric drugs simultaneously)
Age
From 30 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 22
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
Heshmat Hospital In Rasht
Street address
Heshmat Hospital, Dr Heshmat Crossroads, Beheshti Highway, Rasht City, Guilan Province
City
Rasht
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
From the Master's thesis

Health conditions studied

1

Description of health condition studied
Coronary heart disease
ICD-10 code
I25.9
ICD-10 code description
Ischaemic heart disease (chronic) NOS

Primary outcomes

1

Description
Dipression
Timepoint
Before intervention and one month after intervention
Method of measurement
Beck Depression Inventory Form 13 question.

2

Description
anxiety
Timepoint
before intervention and one month after intervention
Method of measurement
Spielberger Trait Anxiety Inventory state

3

Description
Hostility
Timepoint
Before intervention and one month after intervention
Method of measurement
Hostility measures Check List-90 revised (SCL-90-R),

Secondary outcomes

1

Description
Electrocardiographic changes
Timepoint
Before intervention and one month after intervention
Method of measurement
Electrocardiography

Intervention groups

1

Description
Experimental group Received 8 sessions training of Mindfulness (4 weeks, each week 2 session being 2 hours) that offered Group training.
Category
Rehabilitation

2

Description
The control group did not receive mindfulness training. they Only complete pre-test and post-test (questionnaire survey).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Heshmat Hospital In Rasht
Full name of responsible person
Dr. Arsalan Salari
Street address
Heshmat Hospital, Dr Heshmat Crossroads, Beheshti Highway, Rasht City, Guilan Province
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr.Arsalan Salari
Street address
Guilan University of Medical Sciences,Six Kilometers From Rasht To Tehran Streets, Guilan Province
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Heshmat Hospital In Raht
Full name of responsible person
Mahsa jahangirpour
Position
MS In Psychology
Other areas of specialty/work
Street address
Second Floor, The First Block, Houses The Corporate, Khalil Abad, Rudbar City, Guilan Province
City
Rudbar
Postal code
Phone
+98 13 2622 2708
Fax
Email
Mjahangirpour@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Departman of Cardiovascular, Heshmat Hospital In Rasht
Full name of responsible person
Arsalan Salari
Position
Cardiovascular Specialty
Other areas of specialty/work
Street address
Heshmat Hospital, Dr Heshmat Crossroads, Beheshti Highway, Rasht City, Guilan Province
City
Rasht
Postal code
Phone
+98 911 348 6964
Fax
Email
A.salari55@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University Of Guilan
Full name of responsible person
Mahsa jahangirpour
Position
MS in Psychology
Other areas of specialty/work
Street address
Second Floor, The First Block, Houses The Corporate, Khalil Abad, RudbarCity, Guilan Province
City
Rudbar
Postal code
Phone
+98 13 2622 2708
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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