Effect of Self-Care Education on Quality of life among Patients with Permanent Pacemakers at Rajaie Cardiovascular, Medical and Research Center in 2012
Inclusion criteria:
All patients who are candidate for permanent pacemaker implantation
:Exclusion criteria
Patients with known psychiatric disorders; Patients with chronic diseases (epilepsy, stroke, cancer, ...); Patients with known physical disabilities (deaf, blind); History of major surgery (heart, brain, hip,...); Prolonged hospitalization; No consent for the study; Pacemaker implantation in other centers; Mental disorders; Patients who experience complications during procedure; Age less than 16 years; Patients who have no access to audiovisual devices to watch the educational movie
Patients in need for permanent pacemaker implantation are randomly assigned into two intervention group (n=40) and control group (n=40). Only patients in the intervention group are received self-care education by movie and pamphlet. Quality of life questionnaire for cardiac patients (Macnew) and self care questionnaire (designed by the study investigators) are completed for all patients before study and one month after device implantation. All data are analyzed by SPSS
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302211965N6
Registration date:2013-05-11, 1392/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-11, 1392/02/21
Registrant information
Name
Majid Haghjoo
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2163
Email address
majid.haghjoo@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self care Education on Quality of life among patients with permanent pacemaker
Public title
Self care Education and quality of life among patients with permanent pacemaker.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who are candidate for permanent pacemaker implantation
Exclusion criteria:
Patients with known psychiatric disorders; Patients with chronic diseases (epilepsy, stroke, cancer, ...); Patients with known physical disabilities (deaf, blind); History of major surgery (heart, brain, hip,...); Prolonged hospitalization; No consent for the study; Pacemaker implantation in other centers; Mental disorders; Patients who experience complications during procedure; Age less than 16 years; Patients who have no access to audiovisual devices to watch the educational movie
Age
From 16 years old to 90 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)
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, Tehran university of medical sciences
Street address
Tehran university of medical sciences
City
Tehran
Postal code
Approval date
2013-02-18, 1391/11/30
Ethics committee reference number
118546
Health conditions studied
1
Description of health condition studied
Arrhythmia
ICD-10 code
I30-I52
ICD-10 code description
Other forms of heart disease
Primary outcomes
1
Description
Quality of life
Timepoint
before intervention and 1 month after intervention
Method of measurement
MACNEW HEART DISEASE HEALTH-RELATED QUALITY OF LIFE QUESTIONNAIRE
Secondary outcomes
empty
Intervention groups
1
Description
Patients in need for permanent pacemaker implantation are randomly assigned into two intervention group and control group. Only patients in the intervention group are received self-care education by movie and pamphlet about the heart function, pacemaker function, and pre- and postoperative care. Quality of life questionnaire for cardiac patients (Macnew) and self care questionnaire (designed by the study investigators) are completed for all patients before study and one month after device implantation.
Category
Other
2
Description
nothing intervention do in control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular medical and research center, tehran university of medical sciences, Tehran, Ir
Full name of responsible person
Dr. majid haghjoo
Street address
valiaser st, niayesh highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. majid haghjoo
Street address
valiaser st, niayaesh highway
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 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
Rajaie Cardiovascular Medical and Research Center, Tehran university of medical sciences, Tehran, Ir
Full name of responsible person
Dr. Majid Haghjoo
Position
Associate Professor
Other areas of specialty/work
Street address
valiaser st, niayesh highway
City
Tehran
Postal code
Phone
+98 21 2392 2163
Fax
Email
Majid.haghjoo@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular medical and research center, tehran university of medical sciences, Tehran, Ir
Full name of responsible person
Dr. majid haghjoo
Position
Associated professor
Other areas of specialty/work
Street address
valiaser st, niayesh highway
City
Tehran
Postal code
Phone
+98 21 2392 2163
Fax
Email
Majid.haghjoo@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rajaie Cardiovascular medical and research center, tehran university of medical sciences, Tehran, Ir
Full name of responsible person
Dr. majid haghjoo
Position
Associated professor
Other areas of specialty/work
Street address
valiaser st, niayesh highway
City
Tehran
Postal code
Phone
+98 21 2392 2163
Fax
Email
Majid.haghjoo@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)