This study is a randomized single-blinded, controlled clinical trial, aimed to compare orientation program and educational pamphlet on anxiety in patients who need to undergo MRI. This study will be carried out on 90 patients referred to the MRI center of 22-Bahman Hospital according to inclusion criteria. Randomization will be done using sealed envelopes. In Intervention group 1, Pamphlet about the definition MRI, preparation before the procedure, explanations about all the steps before, during and after the MRI, ways to reduce anxiety during the procedure and explaining the potential risks and benefits of MRI are given to patients in a simple and understandable way. In Intervention group 2, educational content similar to Intervention group 1 will be provided by researcher to every patient through face-to-face education. The patients will be given enough time to express their feelings and ask any questions they might have. At the end, the patients will be familiarized with MRI room and MRI machine. The control group only will receive routine care and they complete Spielberger Anxiety and demographic questionnaires. Patients’ anxiety prior to MRI will be reaffirmed using Spielberger anxiety questionnaire. All patients in intervention groups will complete demographic and Spielberger Anxiety questionnaires before and after the intervention. The main outcome will be level of anxiety.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016061228404N1
Registration date:2017-04-02, 1396/01/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-02, 1396/01/13
Registrant information
Name
Habib Shareinia
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57229878
Email address
shareinia.h@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Gonabad University of Medical Sciences
Expected recruitment start date
2016-05-12, 1395/02/23
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare orientation program and educational pamphlet on anxiety in patients who need to undergo MRI
Public title
The effect of orientation program and educational pamphlet on anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: need for MRI; age over 18 years; having no history of previous MRI; not use any kinds of hypnotics and sedatives; not having been hospitalized. Exclusion criteria:having history of known psychiatric disorders; being addict to any kinds of drugs
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done using sealed envelopes
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
Postal code
05157223028
Approval date
2016-05-11, 1395/02/22
Ethics committee reference number
IR.GMU.REC.1395.31
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Anxiety state
Primary outcomes
1
Description
Anxiety
Timepoint
Before and After training
Method of measurement
Spielberger's State-Trait Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In Intervention group 1, Pamphlet about the definition MRI, preparation before the procedure, explanations about all the steps before, during and after the MRI, ways to reduce anxiety during the procedure and explaining the potential risks and benefits of MRI are given to patients in a simple and understandable way.
Category
Prevention
2
Description
In Intervention group 2, educational content similar to Intervention group 1 will be provided by researcher to every patient through face-to-face education. The patients will be given enough time to express their feelings and ask any questions they might have. At the end, the patients will be familiarized with MRI room and MRI machine.