Protocol summary

Study aim
Determining the Effect of Two Methods of Group Training and Individual Training on Knowledge and Anxiety of Family Members of Candidates for Coronary Angiography
Design
This randomized clinical trial with parallel groups will be performed on 60 family members of the patient who are candidates for coronary angiography. Participants in this study will be divided into three groups by dice throwing.Intervention group 1: For group training, family members of patients are placed in 7 groups of 6 people.Intervention group 2: Individual training is given to each patient's family member.Intervention group 3: As a control group, no training will be received.
Settings and conduct
This randomized study was conducted to determine the effect of two methods of group training and individual training on knowledge and anxiety of family members of candidates for coronary artery angiography who referred to Amiralmomenin-e-Kordokhi Hospital.The participants in the study will be divided into three groups by dice throwing.Intervention group 1: For group training, family members of patients are placed in 7 groups of 6 people.Intervention group 2: Individual training is given to each patient's family member.Intervention group 3: As a control group, no training will be received.
Participants/Inclusion and exclusion criteria
including Criteria: Having a patient undergoing angiography at the time of the research،ّaged over 18 years excluding criteria: Having an experience of caring for the patient under angiography،Emergency Angiography
Intervention groups
Intervention group 1: For group training, family members of patients are placed in 7 groups of 6 people. Intervention group 2: Individual training is given to each patient's family member. Intervention group 3: As a control group, no training will be received.
Main outcome variables
Level of anxiety, level of awareness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190304042909N1
Registration date: 2019-06-08, 1398/03/18
Registration timing: registered_while_recruiting

Last update: 2019-06-08, 1398/03/18
Update count: 0
Registration date
2019-06-08, 1398/03/18
Registrant information
Name
Zahra Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 8465
Email address
z.heidari@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2019-12-31, 1398/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing two methods of group training and individual training on anxiety of family members of candidates for coronary angiography .
Public title
Comparing two methods of group training and individual training on anxiety of family members of candidates for coronary angiography .
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a patient undergoing angiography at the time of the research and referring to the patient's caregiver Having a blood relationship with the patient Ability to understand and understand Persian language
Exclusion criteria:
Having a history of caring for the patient under angiography Having known psychological illness Emergency Angiography Patient
Age
From 18 years old
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
Participants in the study will be divided into three groups of group training individual and control education by dice throwing.
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 Golestan University Of Medical Sciences
Street address
Golestan University Of Medical Science, Shast kolah Street
City
Gorgan
Province
Golestan
Postal code
4916746641
Approval date
2018-09-24, 1397/07/02
Ethics committee reference number
IR.GOUMS.REC.1396.159

Health conditions studied

1

Description of health condition studied
Anxiety of Family Members of Patients Candidate for Coronary Angiography
ICD-10 code
I20-I25
ICD-10 code description
Ischemic Heart Disease

Primary outcomes

1

Description
Anxiety level
Timepoint
Before training and after training
Method of measurement
spielberger anxiety questionnaire

2

Description
Awareness level
Timepoint
Before training and after training
Method of measurement
Knowledge measurement questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: For group training, family members of patients are placed in 7 groups of 6 people.
Category
Other

2

Description
Intervention group2:Individual training is given to each patient's family member
Category
Other

3

Description
Control group: No training will be received.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital, Kurdkooy City
Full name of responsible person
Mehdi Farzadmehr
Street address
Amir Al-Momenin Hospital، Jangal Street
City
Golestan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1721
Email
Farzadmehr87@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Street address
Golestan University Of Medical Science، Shast kolah Street
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1721
Email
Farzadmehr87@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Mehdi Farzadmehr
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golestan University Of Medical Science, Shast kolah Street
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1721
Email
Farzadmehr87@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mehdi Farzadmehr
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golestan University Of Medical Science- Shast kolah Street
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1721
Email
Farzadmehr87@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mahdi Farzadmehr
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golestan University Of Medical Science- Shast kolah Street
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1721
Email
Farzadmehr87@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...