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The effect of psychological preparation on level of anxiety associated with Coronary artery bypass grafting (CABG) before and after surgery in hospitalized patients of Ahvaz golestan hospital

Protocol summary

Summary
In this randomized controlled trial 112 patients who were hospitalized in coronary artery surgery department of Ahvaz Golestan Hospital were selected. According to random number table, patients were divided into two groups of control and intervention, that each group has 56 members. Aim of the study was explained to the patients, and then they were asked to fill out the consent form. After the inclusion and exclusion criteria were taken into account, the patients were randomly divided into an experimental and a control group. Inclusion criteria such as age of 18-80 years, participants should able to communicate, and can speak Farsi, and Exclusion criteria like having cognitive problem, and if they had history of major psychological disorder and cognitive problem, they were excluded. This study is open-label and categorize in 2-3 trial phase. Aim of this study is determining state and trait anxiety and compares them in intervention and control group. A Spielberg questionnaire for measuring level of anxiety was used and filled out by patients in 2 times. The first time when patients hospitalized to the coronary artery part that represents the basic anxiety and the second time, two days after surgery when they left the ICU. For the experimental group, after the questionnaire was completed in the first phase, psychological preparation was carried out for the patients. After their anxiety, information, and beliefs about heart surgery were assessed, the intervention was carried out in three areas: Information control, Cognitive and Behavioral control (special breath exercises, swallowing training, and distraction technique). The same time, pamphlets (properties of fruits and vegetables) gave to control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016031120739N3
Registration date: 2016-06-10, 1395/03/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-10, 1395/03/21
Registrant information
Name
Forouzan Behroozina
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
behrouzian-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-08-22, 1394/05/31
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psychological preparation on level of anxiety associated with Coronary artery bypass grafting (CABG) before and after surgery in hospitalized patients of Ahvaz golestan hospital
Public title
The effects of psychological preparation on the level of anxiety resulting from heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 80-18 years; Farsi language skills; ability to communicate verbally; consent to enter the scheme Exclusion criteria: Dementia; cognitive impairment (such as delirium); mental retardation; obvious physical problems that interference in consultation; history of major psychiatric disorders; stopping of cooperation from the patient and when the patient's anxiety is high that not to be able to cooperate.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was done by random number table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
Ir.ajums.REC.1394.21

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
ّF40,F41,F
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
State Anxiety
Timepoint
Before Intervention - After Intervention
Method of measurement
Questionnaire

2

Description
Trait Anxiety
Timepoint
Before Intervention - After Intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A Spielberg questionnaire for measuring level of anxiety was used and filled out by patients in 2 times. The first time when patients hospitalized to the coronary artery part that represents the basic anxiety and the second time, two days after surgery when left the ICU. For the experimental group, after the questionnaire was completed in the first phase, psychological preparation was carried out for the patients. After their anxiety, information, and beliefs about heart surgery were assessed, the intervention was carried out in three areas: Information control, Cognitive and Behavioral control (special breath exercises, swallowing training, and distraction technique)
Category
Behavior

2

Description
Control group: The length of time it takes for cases for intervention, And more neutral (properties of fruits and vegetables) that are pamphlets for studying the control groups are no longer used.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Golestan hospital
Full name of responsible person
Forouzan Behrouzian
Street address
Golestan Hospital, Golestan Blvd, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Forouzan Behrouzian
Street address
Ahvaz Golestan Hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Forouzan Behrouzian
Position
Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
fbehrouzian2@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Forouzan Behrouzian
Position
Assistant Professor
Other areas of specialty/work
Street address
Golestan Hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
fbehrouzian2@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Seyedeh Tahere Jazayeri
Position
Assistant
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
Drtaherehjazayeri@gmail.com
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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