Comparison of the efficacy of eye movement desensitization and reprocessing procedure and progressive counting technique on anxiety, depression, stress and quality of life in patients undergone coronary artery bypass graft surgery
comparison the efficacy of EMDR procedure and progressive counting technique on anxiety, depression, stress and quality of life in patients undergone coronary artery bypass graft surgery.
Design
60 eligible patients will be selected and randomly assigned to intervention groups including EMDR, PC, and control group. participants will be assigned to each groups after matching them based on their age and gender and designating numbers from 1 to 60. subsequently, using random number selection software each participants will be randomly assigned to one of the three groups.
Settings and conduct
patients will participate in the study who undergone Coronary artery bypass graft , followed by 4 to 6 weeks of recuperation period will be eligible for rehabilitation and will be referred to the heart rehabilitation center of Tehran Heart Center Hospital for completing rehabilitation.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Samples include patients undergone Coronary artery bypass graft surgery, followed by 4 to 6 weeks of recuperation period will be eligible for rehabilitation, the cut off point of 24 and above in IES- Revised, and not having received any kind of psychological intervention or counseling.
Exclusion criteria are: Having sustained angina pectoris, acute phase of myocardial infarction and unstable arrhythmia Education less than diploma
Intervention groups
EMDR :A traumatic memory related to CABG procedure will be selected and reviewed simultaneously by tracing the hand movement of the therapist thereby inducing exposure.
Progressive Counting: A traumatic memory related to CABG procedure will be selected and reviewed simultaneously with progressive counting by the therapist counting from 1 to 100 thereby inducing exposure.
Control group: no intervention
Main outcome variables
Emotional signs (anxiety, stress, depression), QOL
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180707040373N1
Registration date:2018-07-17, 1397/04/26
Registration timing:registered_while_recruiting
Last update:2018-07-17, 1397/04/26
Update count:0
Registration date
2018-07-17, 1397/04/26
Registrant information
Name
Mohammad Reza Abdoli Bidhendi
Name of organization / entity
Semnan University
Country
Iran (Islamic Republic of)
Phone
+98 21 6643 8583
Email address
mrbidhendi@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-11, 1397/04/20
Expected recruitment end date
2018-09-11, 1397/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of eye movement desensitization and reprocessing procedure and progressive counting technique on anxiety, depression, stress and quality of life in patients undergone coronary artery bypass graft surgery
Public title
The impact of eye movement desensitization and reprocessing and progressive counting on CABG
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The sample population included patients undergone coronary artery bypass graft surgery who were candidates for cardiac rehabilitation 4 to 6 weeks after surgery.
Patients undergone coronary artery bypass grafting that score 24 and above on impact of events scale- revised
Not receiving any psychological treatment or counseling before intervention period
Exclusion criteria:
Having sustained angina pectoris, acute phase of myocardial infarction and unstable arrhythmia
Education less than diploma
Not receiving any psychological treatment or counseling during the intervention period
Age
From 30 months old to 60 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research participants will be selected using a random sampling method. Participants will be assigned to each groups after matching them based on their age and gender and designating each one of them numbers from 1 to 60. Subsequently, using the Random Number Selection software each participant will be randomly assigned to one of the groups.
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 Semnan University of Medical Science
Street address
Mahdishahr ;Education and psychology faculty of semnan university
City
Semnan
Province
Semnan
Postal code
3564111156
Approval date
2018-06-12, 1397/03/22
Ethics committee reference number
IR.SEMUMS.REC.1397.006
Health conditions studied
1
Description of health condition studied
coronary artery bypass graft surgery
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease
Primary outcomes
1
Description
Emotional signs
Timepoint
Before and after of Intervention
Method of measurement
Depression Anxiety Stress Scales (DASS-21)
2
Description
Quality Of Life
Timepoint
Before and after of Intervention
Method of measurement
World Health Organization's Quality Of Life questionnaire (WHOQOL-BREF)
3
Description
Signs of Post Traumatic Stress
Timepoint
Before and after of Intervention
Method of measurement
Impact of Event Scale - Revised
Secondary outcomes
empty
Intervention groups
1
Description
The present study includes 2 types of intervention: 1) Eye Movement Desensitization and Reprocessing; 2) Progressive Counting; and 3) a control group.First, a pretest will be obtained from all 3 groups. Then, intervention that include 6 sessions will be carried out in the 2 experimental groups. Finally, a post test will be taken from all 3 groups. Subsequently, after six months a follow up evaluation will be taken from all three groups.
Category
Treatment - Other
2
Description
Intervention group: Intervention group 2, progressive counting. Progressive counting is a new method of resolving trauma. In this method, the therapist uses progressive counting (1 to 10, then 1 to 20, and so to 100), and at the same time asks client to do the imagination on a traumatic event from the beginning to the end to treat his/her traumatic memory.
Category
Treatment - Other
3
Description
Control group: No intervention, only as control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Nazila Shah Mansouri
Street address
North Kargar-Ave , Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
n.shahmansouri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University- Faculty of psychology and education
Full name of responsible person
Dr. Parvin Rafieinia
Street address
Mahdishahr, faculty of psychology and education,Semnan University
City
Mahdishahr
Province
Semnan
Postal code
356411156
Phone
+98 23 3362 4250
Email
p_rafieinia@semnan.ac.ir
Web page address
http://psy.semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University- Faculty of psychology and education
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of psychology and education- Semnan University
Full name of responsible person
Mohammad Reza Abdoli Bidhendi
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 15, Vahid-e- gharbi alley, Kokab st., Sattarkhan st., Tehran
City
Tehran
Province
Tehran
Postal code
1441993813
Phone
+98 21 6643 8583
Email
mrbidhendi@semnan.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Parvin Rafieinia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mahdishahr, Faculty of psychology and education, Semnan University
City
Semnan
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 4250
Email
p_rafieinia@semnan.ac.ir
Web page address
http://psy.semnan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Mohammad Reza Abdoli Bidhendi
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mahdishahr, Faculty of psychology and education, Semnan University
City
Semnan
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 4250
Email
mrbidhendi@semnan.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
Not applicable
Title and more details about the data/document
Research findings will be published in scientific journals.
When the data will become available and for how long
The documentation and research results are likely to be published in 2018-2019.
To whom data/document is available
The full research document will be available in Semnan University, faculty of Psychology and education. Research results will be available to researchers as an article and book.
Under which criteria data/document could be used
Using the results of the study, mentioning the number of participants in the study, the type of population and the research sample, as well as mentioning the interventions allowed.
From where data/document is obtainable
Semnan University, faculty of psychology and education, Information and Documentation Center of Iran (IranDoc) Or sending a message to researcher: mrbidhendi@yahoo.com
What processes are involved for a request to access data/document
Visiting the Irandoc center or Semnan University Library Or one week after sending email to the writer