The effect of the first phase of cardiac rehabilitation programs on illness perception and Hospital anxiety and depression in patients with acute coronary syndrom
Anxiety and Depression following cardiac events is associated with higher mortality and illness perception appears to be on important psychosocial factor in acute recovery from cardiac event, but little is known about whether this can be reduced through treatment including cardiac rehabilitation. The purpose of this study was to assess the effects of phase 1 cardiac rehabilitation on illness perception and Hospital anxiety and depression among acute coronary syndrome patients. This is a semi-experimental clinical trial on 90 first ACS patients admitted to the CCU and Post CCU wards which have been sampled simply and randomized divided in to experimental (n=45) and control (n=45) groups . The control group received only hospitals routine program, while the experimental group in addition to receiving usual care, will participate in phase 1cardiac rehabilitation program. Phase 1cardiac 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. The data gathering tools were demographic and disease related questionnaires, Persian version of Illness perception questionnaire (IPQ) and Hospital Anxiety Depression Score (HADS). Data were collected to baseline and 5 days following ACS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112314443N4
Registration date:2012-06-12, 1391/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-12, 1391/03/23
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the first phase of cardiac rehabilitation programs on illness perception and Hospital anxiety and depression in patients with acute coronary syndrom
Public title
The impact of cardiac rehabilitation programs first phase on illness perception and Hospital anxiety and depression in patients with acute coronary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis is confirmed by medical experts and the results of diagnostic test; mental illness are not known and not taking drugs that affect mental; Have the ability to understand conversations in Persian; Have at least read and writer; Be admitted for the first time.
Exclusion criteria: the patient dies during the study; Stage of disease is acute and severe; Lack of patient cooperation in data collection.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
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
Tehran University of Medical Sciences
Street address
Tehran - Keshavarz Blvd - University of Central Organization
City
Tehran
Postal code
Approval date
2012-01-21, 1390/11/01
Ethics committee reference number
15169
Health conditions studied
1
Description of health condition studied
Acute coronary syndrom
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified
Primary outcomes
1
Description
Illness perception
Timepoint
before and after intervention
Method of measurement
Illness Perception Questioaire
Secondary outcomes
1
Description
Hospital Anxiety Depression
Timepoint
before and after intervention
Method of measurement
Hospital Anxiety Depression Score
Intervention groups
1
Description
The control group received only hospitals routine program includes brief information about the disease and treatment program
Category
Rehabilitation
2
Description
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital - cardiac care unit، Post cardiac care unit
Full name of responsible person
sedigheh arefi
Street address
Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
2
Recruitment center
Name of recruitment center
shariati hospital - cardiac care unit ، Post cardiac care unit
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
University Research Assistant, Dr Photoohi
Street address
Ghods street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
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
Tehran University of Medical Science
Full name of responsible person
Masoumeh Zakerimoghadam
Position
MS./Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Masoumeh Zakerimoghadam
Position
MS./Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Masoumeh Zakerimoghadam
Position
MS./Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)