Protocol summary

Summary
The aim of this study was to examine the effect of cardiac rehabilitation on anxiety and depression in patients after coronary artery bypass grafting. inclusion criteria were: 40-70 years of age, scheduled for Coronary artery Bypass Graft Surgery by a cardiologist. The exclusion criteria were: history of mental illness; previous participation in cardiac rehabilitation programs. For this randomized controlled trial, 80 patients who met the inclusion criteria were recruited and randomly assigned to case and control groups.Data collection tools was demographic questionnaire,Beck Depression Inventory and Spielberger Anxiety Questionnaire. Depression was measured using Beck’s Depression Inventory and anxiety was measured using Spielberger Anxiety Questionnaire at three points in time: on discharge from the hospital, immediately after the intervention, and 2 months after cardiac rehabilitation. After measuring anxiety and depression in both groups upon discharge, the experimental group participated in 8 cardiac rehabilitation sessions over a 4-week period. The control group received only the routine follow-up care. At the end of rehabilitation, anxiety and depression was measured in patients in both groups.In third stage (2 months after cardiac rehabilitation) again anxiety and depression was measured in patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203262812N8
Registration date: 2012-03-31, 1391/01/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-03-31, 1391/01/12
Registrant information
Name
Farkhondeh Sharif
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1212 2401
Email address
fsharif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2009-02-04, 1387/11/16
Expected recruitment end date
2009-09-10, 1388/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cardiac Rehabilitation on Anxiety and Depression in Patients Undergoing Cardiac Bypass Graft Surgery in Iran
Public title
cardiac rehabilitation after Coronary Artery Bypass Graft Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria were: 40-70 years of age; an ejection fraction ratio of over 40%; scheduled for Coronary Artery Bypass Graft Surgery by a cardiologist; ability to read; write; perform the exercises in the rehabilitation program and attend rehabilitation sessions. The exclusion criteria were: history of mental illness; previous participation in cardiac rehabilitation programs; death or recurrence of illness and hospitalization; disorder or disability that interfered with the patient’s ability to do the rehabilitation exercises; history of cardiac surgery; urgent need for surgery; history of coronary artery bypass Surgery accompanied with other operations such as valve transplantation. taking major trangulizor and anti-anxiety medications.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Central building, Zand St.
City
Shiraz
Postal code
Approval date
2008-11-21, 1387/09/01
Ethics committee reference number
CT88

Health conditions studied

1

Description of health condition studied
Depression and Anxiety
ICD-10 code
F30 و 39
ICD-10 code description
mood(affective)disorder

Primary outcomes

1

Description
Depression
Timepoint
immediately and two months after intervention
Method of measurement
Depression y Questionnaire

2

Description
Anxiety
Timepoint
immediately and two months after intervention
Method of measurement
Anxiety Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group participated in 8 cardiac rehabilitation sessions over a 4-week period (intervention1).
Category
Rehabilitation

2

Description
Control Group received only the routine follow-up care (intervention 2).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Mottahari Clinic
Full name of responsible person
Dr Farkhondeh Sharif
Street address
Zand street, Shiraz University of Medical Sciences,next to red cresent
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
DrGholamreza Hatam
Street address
Shiraz University of Medical Sciences,University Central Building,Zand street, beside red cross
City
Shiraz
Grant name
Grant code / Reference number
CT88
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences,
Full name of responsible person
Farkhondeh Sharif
Position
Ph.D
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, ZAND Street, University central building, Next to Red Cresent
City
Shiraz
Postal code
71345-1359
Phone
+98 71 1212 2401
Fax
Email
fsharif@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farkhondeh sharif
Position
Ph.D
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Central Building,
City
Shiraz
Postal code
71345-1359
Phone
+98 71 1212 2401
Fax
Email
FSHARIF@SUMS.AC.IR
Web page address

Person responsible for updating data

Contact

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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