The aim of this study is to determine the effect of multi-modal education on anxiety in patients undergoing coronary angiography. This study is double-blind clinical trial with a sample size of 120 patients undergoing coronary angiography referred to educational and treatment centers in Urmia, which were selected by a convenience sampling method and are divided into one of three intervention groups (30) or control group (30). Random assignment of subjects will be, through the 120 number written on a small slip of paper located within an envelope and Specified that number between 1-30 to the control group, 31-60 to the peer education, 61-90 to the video education group, 91-120 to multi-modal education group is assigned. The day before angiography after informed consent by patients and a random selection of numbers in the envelope and allocation of patients to the target group, spielberger anxiety questionnaire and demographic characteristics will be completed. In a Peer education group, the experiences of two people who have been angiography at the center is used to reduce patients anxiety. In video-traning group educational videos of real environment angiography of the center is displayed. In multi-modal education group Measures taken in both video and peer education will be provided. The control group will be received standard measures. On the morning of angiography anxiety of patients are assessed in intervention and control groups. Data will be analyzed by statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072429052N1
Registration date:2016-09-14, 1395/06/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-14, 1395/06/24
Registrant information
Name
Zahra Dalayi Milan
Name of organization / entity
Urmia medical sciences university
Country
Iran (Islamic Republic of)
Phone
+98 44 3384 3501
Email address
dalayi.z@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
The Office of the Vice Chancellor for Research, Urmia University of Medical Sciences
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2016-09-05, 1395/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multi-modal education on anxiety in patients undergoing coronary angiography
Public title
The effect of multi-modal education on anxiety in patients undergoing angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18-80 years; Can read and right; Not be healthcare provider; Lack of Previous angiography; Lack of Participation in the previous similar research project; Lack of mental illness and chronic physical and cognitive disorders; hearing and vision; Lack of using drugs and psychotropic substances; Lack of experience stressful events except current disease during the last 3 months. Exclusion criteria: Reception anti-anxiety medication over a week ago.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Blinding of study this means that, Both patients as well as researcher from which patients will be assigned to which group do not have any information.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Emergency district, Resalat Blvd, Urmia
City
Urmia
Postal code
5714783734
Approval date
2016-05-04, 1395/02/15
Ethics committee reference number
IR.umsu.rec.1395.21
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
A disorder characterized by the essential descriptive features of a generalized anxiety disorder (F41.1), a panic disorder (F41.0), or a combination of both, but arising as a consequence of an organic disorder
Primary outcomes
1
Description
Anxiety
Timepoint
before and after intervention
Method of measurement
Spielberger State anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
Multi-modal education: This program includes actions on both video and peer education that compilation is two 30-minute session in evening shift of the day before angiography is done in the hospital. In the first step video education offered, after taking 15 minutes rest, the second meeting of the peer education will be conducted under the supervision and coordination of the researcher.
Category
Behavior
2
Description
Peer education: This program is a 30-minute session in evening shift of the day before angiography is done in the hospital. Two people who have recently been at the center angiography and have a positive experience of this effort, after receiving the necessary training, about their feelings and experiences in the period before, during and after coronary angiography talk with 4-6-member groups of patients in order to reduce their anxiety.
Category
Behavior
3
Description
Video education: This program is a 30-minute session in evening shift of the day before angiography is done in the hospital. Educational video about actions before, during and after coronary angiography for 5 minutes and films made from the actual environment of the center for 15 minutes will be presented for patients.
Category
Behavior
4
Description
Control group: Routine training will be conducted in the control group