The Effect of Cardiac Pain Management and Cardiopulmonary Resuscitation Trainings on Self-control, Depression and Anxiety in the Spouses of the Patients with Myocardial Infraction Admitted to the Hospitals Affiliated to Shiraz University of Medical Sciences
Goal of the study: to investigate the effect of cardiac pain management and cardiopulmonary resuscitation trainings on self-control, depression, stress and anxiety in the spouses of the patients suffering from myocardial infraction who admitted to Coronary Care Units of the hospitals affiliated to Shiraz University of Medical Sciences. Design: This is an interventional study. Sampling methods: participants (N=84) were randomly assigned into case and control groups (two groups of 42 each). Setting and conduct: after obtaining informed consent, Depression, Anxiety and Stress Scale and Rotter's Internal-External Locus of Control Scale were completed by participants before the intervention. Inclusion criteria: included ability to understand the information presented (which is confirmed by researcher) and not participating in similar training programs simultaneously or since 6 months before the study. Exclusion criteria: included unwillingness to participate in the study and any debilitating psychiatric diseases such as psychosis. Intervention: the participants in the case group attended workshops including theoretical and cardiopulmonary resuscitation practical trainings. One month later, the researcher met the participants of the case group at their home, reviewed the trainings and answered all their questions regarding the trainings they received. The questionnaires were completed again by the participants of the case group immediately after and one month after the intervention; while the participants of the control group completed them only one month after the intervention. The study lasts for five months in both groups. Primary outcome measures included: self-control, depression, stress and anxiety in the spouses of the patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310128124N2
Registration date:2014-07-03, 1393/04/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-03, 1393/04/12
Registrant information
Name
Zahra Molazem
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
molazem@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cardiac Pain Management and Cardiopulmonary Resuscitation Trainings on Self-control, Depression and Anxiety in the Spouses of the Patients with Myocardial Infraction Admitted to the Hospitals Affiliated to Shiraz University of Medical Sciences
Public title
The Effect of Cardiac Pain Management and Cardiopulmonary Resuscitation Trainings on Self-control, Depression and Anxiety in the Spouses of the Patients with Myocardial Infraction Admitted to the Hospitals Affiliated to Shiraz University of Medical Sciences
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included ability to understand the information presented (which is confirmed by researcher) and not participating in similar training programs simultaneously or since 6 months before the study. Exclusion criteria included unwillingness to participate in the study and any debilitating psychiatric diseases such as psychosis
Age
From 40 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
84
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences Shiraz, Zand Blvd.
City
Shiraz
Postal code
Approval date
2013-08-19, 1392/05/28
Ethics committee reference number
CT-92-6680
Health conditions studied
1
Description of health condition studied
Decreased self-control
ICD-10 code
F60.3
ICD-10 code description
Emotionally unstable personality disorder
2
Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
3
Description of health condition studied
Anxiety and Depression
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder
Primary outcomes
1
Description
Stress
Timepoint
Before, immediately after and one month after the intervention
Method of measurement
Depression, Anxiety and Stress Scale
2
Description
Anxiety
Timepoint
Before, immediately after and one month after the intervention
Method of measurement
Depression, Anxiety and Stress Scale
3
Description
Depression
Timepoint
Before, immediately after and one month after the intervention
Method of measurement
Depression, Anxiety and Stress Scale
4
Description
Self-control
Timepoint
Before, immediately after and one month after the intervention
Method of measurement
Rotter's Internal-External Locus of Control Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention included holding workshops comprising theoretical and individual cardiopulmonary resuscitation practical trainings for the participants of the case group, telephone follow-ups and visiting the patients at their home.
Category
Prevention
2
Description
Without any intervention on the control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Heart Hospital
Full name of responsible person
Azam Zare
Street address
Sibooyeh Blvd., Shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Ms.Hosseini
Street address
Zand st., Shiraz
City
Shiraz
3
Recruitment center
Name of recruitment center
Nemazee Hospital
Full name of responsible person
Ms. Gholami
Street address
Nemazee Square, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs
Full name of responsible person
Dr. Basir Hashemi
Street address
Central building of Shiraz University of Medical Sciences, Zand st.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, Vice Chancellor for Research Affairs
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
Zahra Molazem
Position
Ph.D
Other areas of specialty/work
Street address
Fatemeh Collage of Nursing and Midwifery (P.B.U.H), Nemazee square
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
molazem@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
Zahra Molazem
Position
Ph.D
Other areas of specialty/work
Street address
Fatemeh Collage of Nursing and Midwifery (P.B.U.H), Nemazee square
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
molazem@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Molazem
Position
Ph.D
Other areas of specialty/work
Street address
Fatemeh Collage of Nursing and Midwifery (P.B.U.H), Nemazee Square
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
molazem@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)