Determining the effect of self-care training by feedback-based method on health anxiety in patients with coronary artery disorders
Design
A clinical trial with a control group with an investigation of the dependent variable of health anxiety and a double-blind and randomized through time block method on 50 patients.
Settings and conduct
Place of study: Heart department of Hazrat Rasool Hospital, Firdous city.
Study population: hospitalized patients with coronary artery disorders.
Type of blinding: No blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
diagnosis of coronary artery disease; Age:18 - 65 years; Having literacy at least reading and writing; independent in performing self-care activities; Willingness to cooperate in the study.
Non-inclusion criteria:
having a debilitating disease; having a history of mental disorders; Participation in other educational programs in this field
Intervention groups
Intervention group: in addition to the department's routine training, self-care training is also carried out in a feedback-oriented way in this group.
Control group: only the department's routine training, such as pamphlets, etc., will be received by these patients.
Main outcome variables
health anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230523058264N1
Registration date:2023-07-11, 1402/04/20
Registration timing:retrospective
Last update:2023-07-11, 1402/04/20
Update count:0
Registration date
2023-07-11, 1402/04/20
Registrant information
Name
Mansoore Barati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3273 1261
Email address
baratim.136563@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-27, 1401/05/05
Expected recruitment end date
2022-09-27, 1401/07/05
Actual recruitment start date
2022-08-16, 1401/05/25
Actual recruitment end date
2022-11-11, 1401/08/20
Trial completion date
empty
Scientific title
The effect of self-care training based on Teach Back method on Health Anxiety in patients with coronary artery disease
Public title
The effect of self-care training on the health anxiety of coronary artery patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of coronary artery disease
Age of 18 - 65 years old
Having literacy of at least reading and writing
Independent in performing self-care activities
Not being part of the health team (the patient himself and his family)
Failure to participate in other educational programs in this field
Willingness to cooperate in the study
Exclusion criteria:
Having a debilitating disease
Having a history of mental disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of one-week time blocks, so that every week according to this sequence, patients will be placed in the intervention or control group to prevent information dissemination. Sampling will be done every week until Monday.
For example: if this week is determined for the intervention group (by chance with the statistical software), all the patients will be considered in the intervention group. Sampling will be done from Saturday to Monday and no new sampling will be done until next Saturday. This group will be taught every other day.
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 Birjand University of Medical Sciences
Street address
Beheshti 7 Blvd
City
Ferdows
Province
South Khorasan
Postal code
9771885784
Approval date
2022-07-05, 1401/04/14
Ethics committee reference number
IR.BUMS.REC.1401.146
Health conditions studied
1
Description of health condition studied
CAD
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Health anxiety score in Salkofakis questionnaire
Timepoint
Before the intervention, two weeks after the intervention
Method of measurement
health anxiety questionnaire of Salkofakis 1 et al. (2002)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: feedback-based self-care training on coronary artery disease was given during one week and three sessions, which were held on a daily basis, and the health anxiety questionnaire was filled before and two weeks after the intervention. This training continues until the patient fully understands. The list is completed by the research assistant to ensure complete understanding).
Category
N/A
2
Description
Control group: The control group is only given routine training and the questionnaire is completed in two stages (first and two weeks later). Determination of intervention and control group is completely random based on spss software
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool hospital
Full name of responsible person
Mansoore Barati
Street address
Emam Reza Boulevard
City
Ferdous
Province
South Khorasan
Postal code
9771885784
Phone
+98 56 3162 7800
Email
Baratim.136563@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. ahmad Nasiri
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
9771885784
Phone
+98 56 3238 1426
Email
baratim.136563@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mansoore Barati
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Beheshti 7 Boulevard
City
Ferdows
Province
South Khorasan
Postal code
9771885784
Phone
+98 56 3273 1261
Email
Baratim.136563@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mansoore Barati
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Beheshti 7 Boulevard
City
Ferdows
Province
South Khorasan
Postal code
9771885784
Phone
+98 56 3273 1261
Email
Baratim.136563@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mansoore Barati
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
9771885784
Phone
+98 56 3238 1426
Email
Baratim.136563@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data can be shared after anonymizing the patients
When the data will become available and for how long
Six months after paper publish
To whom data/document is available
Researchers working at the university
Under which criteria data/document could be used
When need to use content and data
From where data/document is obtainable
Postal address and email address and contact number
What processes are involved for a request to access data/document
With any of the above methods, they can use the documents in less than a day