Protocol summary

Summary
1): The aim of this study was to determine the impact of first phase cardiac rehabilitation program on anxiety, depression and stress in elder coronary patients. 2): This is a semi-experimental clinical trial on 70 elder coronary patients admitted to the CCU wards Afshar Hospital and patients will be divided randomly into experimental (n=35) and control (n=35) groups. Data collection were demographic questionnaire and DASS-21 Score. 3): The experimental group will be participated in four educational sessions of cardiac rehabilitation program, which included familiarity with risk factors of heart disease, nutrition and drugs recommendations, stress, anxiety and depression reduction methods and exercises training and The control group will be received only ward routine program. 4)Inclusion criteria: aged ≥60 years, coronary artery disease is confirmed by cardiologist. Exclusion criteria: presence of mental and psychologic diseases, Physical limitation or orthopedic including rheumatologic diseases, A history of confusion and forgetfulness, dementia, medications for mental disorders. 5) The primary outcome of the study : rate of depression, anxiety and stress before and after cardiac rehabilitation

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022726794N1
Registration date: 2017-01-12, 1395/10/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-12, 1395/10/23
Registrant information
Name
Javad Teimouri
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 3620 0916
Email address
javad-teimouri@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of phase I cardiac rehabilitation program on the rate of anxiety, depression and stress in elder coronary patient
Public title
The effect of cardiac rehabilitation on anxiety, depression and stress in elders with Coronary Artery Disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: aged ≥60 years, ability to understand and speak Persian, coronary artery disease is confirmed by cardiologist. Exclusion criteria: presence of mental and psychologic diseases, Physical limitation or orthopedic including rheumatologic diseases, A history of confusion and forgetfulness, dementia, medications for mental disorders.
Age
From 60 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Not 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
Ethics committee of Yazd University of Medical Sciences and Health Services
Street address
Ethics committee of Yazd University of Medical Sciences and Health Services, Bahonar square,Yazd
City
Yazd
Postal code
8916978477
Approval date
2016-06-22, 1395/04/02
Ethics committee reference number
IR.SSU.REC.1395.58

Health conditions studied

1

Description of health condition studied
Depression,Anxiety,Stress
ICD-10 code
F32.0,F32.
ICD-10 code description
Mild depressive episode,Moderate depressive episode,Other depressive episodes,Specific (isolated) phobias,Other phobic anxiety disorders,Panic disorder [episodic paroxysmal anxiety],Mixed anxiety and depressive disorder,Acute stress reaction,Post-traumati

Primary outcomes

1

Description
Depression
Timepoint
pre intervention- 2month post intervention
Method of measurement
DASS-21 Questionnaire

2

Description
Anxiety
Timepoint
pre intervention- 2month post intervention
Method of measurement
DASS-21 Questionnaire

3

Description
Stress
Timepoint
pre intervention- 2month post intervention
Method of measurement
DASS-21 Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: the experimental group in addition to receiving usual care, will participate in phase 1cardiac rehabilitation program. Phase 1 cardiac rehabilitation program included self care and self management education,nutrition recommendations, stress reduction methods and exercises that instructed by researcher in 4 parts of 20 minutes
Category
Rehabilitation

2

Description
Intervention 2 : There will be no intervention for control group . Current treatment
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afshar Hospital
Full name of responsible person
Teimouri Javad
Street address
Yazd School of Nursing & Midwifery, Bu Ali St., Timsar Falahi Ave., Safaeyeh, Yazd, Iran
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Deputy of research and technology
Street address
Bahonar square, Shahid Sadoughi University of Medical Sciences and Health Services,Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences and Health Services
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
Shahid Sadoughi University of Medical Sciences Yazd, School of Nursing & Midwifery
Full name of responsible person
Teimouri Javad
Position
Elderly Nursing Master Science Student
Other areas of specialty/work
Street address
Yazd School of Nursing & Midwifery, Bu Ali St., Timsar Falahi Ave., Safaeyeh, Yazd, Iran
City
Yazd
Postal code
8919848968
Phone
+98 35 3824 1751
Fax
Email
javad-teimouri@ssu.ac.ir javadteimouri1369@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences , School of Nursing & Midwifery
Full name of responsible person
Kalani Zohre
Position
Master of Science in Medical Surgical Nursing
Other areas of specialty/work
Street address
Yazd School of Nursing & Midwifery, Bu Ali St., Timsar Falahi Ave., Safaeyeh, Yazd, Iran
City
Yazd
Postal code
8919848968
Phone
+98 35 3824 1751
Fax
Email
kalani_z @yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences , School of Nursing & Midwifery
Full name of responsible person
Teimouri Javad
Position
Elderly Nursing Master Science Student
Other areas of specialty/work
Street address
Yazd School of Nursing & Midwifery, Bu Ali St., Timsar Falahi Ave., Safaeyeh, Yazd, Iran
City
Yazd
Postal code
8919848968
Phone
+98 35 3824 1751
Fax
Email
javad-teimouri@ssu.ac.irjavadteimouri1369@yahoo.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
Loading...