Protocol summary

Study aim
Determining the effect of EMDR on anxiety, depression ,stress and hemodynamic parameters in patients undergoing CABG.
Design
90 eligible patients included in the study through available sampling, after a thorough explanation of the objectives of the study and informed consent, They were by the randomly blocks method assigned into two groups of control (n = 45) and intervention (n = 45).
Settings and conduct
The present study aimed to evaluate the efficacy of EMDR on anxiety, depression,stress and hemodynamic parameters in patients undergoing CABG and will be referred to the Shahid Rajaei, Educational Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The sample population included patients undergone CABG who were candidates for surgery one week before intervention, Not receiving any psychological treatment or counseling before intervention period. Exclusion criteria: Having sustained stable angina, acute phase of myocardial infarction and unstable arrhythmia, Having Cognitive impairment , Visual disturbances and strabismus
Intervention groups
Intervention group: EMDR method will be done individually conduct for each patient in the consultation room within 2 sessions 30-45 minutes before the surgery . The patient following the rapid movements of the therapist's finger with rapid eye movement. The therapist's finger is about 30 cm far from the eyes of the subject and moved from right to left and vice versa in the patient's field of vision. This move included two rounds to the sides in one second, which is a cycle, and each 12-24 cycles are a set.The process is repeated to the extent that the levels of mental disorientation units are zero or minimized. In the final session, the Depression, Anxiety and Stress Questionnaire will be completed again. The control group :receive no intervention
Main outcome variables
Anxiety؛ Depression؛Stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171223038015N1
Registration date: 2020-02-29, 1398/12/10
Registration timing: retrospective

Last update: 2020-02-29, 1398/12/10
Update count: 0
Registration date
2020-02-29, 1398/12/10
Registrant information
Name
Fatemeh Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3457 0030
Email address
frahimi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2018-12-21, 1397/09/30
Scientific title
The effect of Eye Movement Desensitization and Reprocessing on anxiety, ,depression,stress and hemodynamic parameters in patients undergoing Coronary Artery Bypass Graft (CABG)
Public title
The effect of Eye Movement Desensitization and Reprocessing in patients undergoing Coronary Artery Bypass Graft (CABG)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Undergoing non-emergency open heart surgery for the first time one week before intervention Not receiving any psychological treatment or counseling before intervention period Patient's willingness to participate in the study
Exclusion criteria:
Having sustained stable angina, acute phase of myocardial infarction and unstable Arrhythmia Having Cognitive impairment Visual disturbances and strabismus
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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 Alborz University of Medical Sciences
Street address
No.9,North Yasaman St,East Pone Ave,Dara Town
City
karaj
Province
Alborz
Postal code
3197635141
Approval date
2017-07-24, 1396/05/02
Ethics committee reference number
Abzums.Rec.1396.72

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Depression
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety
Timepoint
Before and after the intervention and after CABG
Method of measurement
anxiety and depression scale (HADS)

2

Description
stress
Timepoint
Before and after the intervention and after CABG
Method of measurement
stress scale(DASS21)

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group": EMDR method will be done individually conduct for each patient in the consultation room within 2 sessions 30-45 minutes before the surgery . The patient following the rapid movements of the therapist's finger with rapid eye movement. The therapist's finger is about 30 cm far from the eyes of the subject and moved from right to left and vice versa in the patient's field of vision. This move included two rounds to the sides in one second, which is a cycle, and each 12-24 cycles are a set.The process is repeated to the extent that the levels of mental disorientation units are zero or minimized. In the final session, the Depression, Anxiety and Stress Questionnaire will be completed again.
Category
Treatment - Other

2

Description
Control group: receive no intervention and only complete depression, anxiety, and stress questionnaires in the first and last sessions of the study.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaei , Educational & Medical Center
Full name of responsible person
Fatemeh Rahimi
Street address
Shahid Rajaei St,Shahid Beheshti Ave,Shahid Rajaei Hospital
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Fax
+98 26 3455 4484
Email
frahimi110@gmail.com
Web page address
https://rajaei.abzums.ac.ir/Portal/Home/Default.aspx

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr Mohamad Noorisepehr
Street address
Shahid Rajaei St,Shahid Beheshti Ave,Shahid Rajaei Hospital
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Fax
+98 26 3455 4484
Email
frahimi110@gmail.com
Web page address
https://rajaei.abzums.ac.ir/Portal/Home/Default.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi
Position
Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
In Critical Care Nursing ( BScN,MScN) Clinical Research Development Unit
Street address
Shahid Rajaei St,Shahid Beheshti Ave,Shahid Rajaei Hospital
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 264570030
Fax
+98 26 3457 0030
Email
frahimi110@gmail.com
Web page address
https://rajaei.abzums.ac.ir/Portal/Home/Default.aspx

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi
Position
Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Rajaei St,Shahid Beheshti Ave,Shahid Rajaei Hospital
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Fax
+98 26 3455 4484
Email
frahimi110@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi
Position
Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Rajaei St,Shahid Beheshti Ave,Shahid Rajaei Hospital
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26034570030
Fax
+98 26 3455 4484
Email
frahimi110@gmail.com
Web page address
https://www.abzums.ac.ir/fa-IR/DouranPortal/1/page/

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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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