In a randomized clinical trial 66 patients who were referred to Ahvaz Golestan Hospital and candidated for head and neck M.R.I were selected.Aim of this study is to determine state and trait anxiety and compare them in intervention and control group. Participants should have the ability to communicate verbal Persian conversation and in case of dementia and the presence of major psychiatric disorders,they were excluded. A Eshpil Berg questionnaire for measuring level of anxiety was used and filled out by patients in 2 times. The first time when patients referred to M.R.I that represents the basic anxiety and the second time after intervention, before M.R.I. For the experimental group, after the questionnaire was completed in the first phase, psychological preparation was carried out for the patients. Information such as time of located in the MRI machine, the voice device, duration and amount of wait time for MRI. After that, their anxiety, information, and beliefs about M.R.I were assessed, the intervention was carried out in three areas: Information control, Cognitive and Behavioral control.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120920739N4
Registration date:2016-12-31, 1395/10/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-31, 1395/10/11
Registrant information
Name
Forouzan Behroozina
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
behrouzian-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psychological preparation on the level anxiety before head and neck M.R.I in outpatients referred to Ahvaz Golestan hospital
Public title
The effect of psychological preparation on the level anxiety before M.R.I
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 16-65 years؛ the language Farsi؛ the ability to communicate verbally؛ with no history of previous head and neck M.R.I;without inclusion M.R.I; a consent to enter the scheme.
Exclusion criteria: the risk of dementia؛ mental retardation؛ distinctive physical problems that interfere consultation; history of major psychiatric disorders؛ that the patients is not cooperative.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients based on 4-of permutation blocks randomly divided into two equal groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd.
City
Ahvaz
Postal code
Approval date
2016-07-09, 1395/04/19
Ethics committee reference number
IRAJUMS.REC.1395.216
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
ّF40,F41,F
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
State Anxiety
Timepoint
Before Intervention - After Intervention
Method of measurement
Eshpil Berger Questionnaire
2
Description
Trait Anxiety
Timepoint
Before Intervention - After Intervention
Method of measurement
Eshpil Berger Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: A Spielberg questionnaire for measuring level of anxiety was used and filled out by patients in 2 times. The first time when patients referred to the M.R.I. that represents the basic anxiety and the second time after intervention and before M.R.After the questionnaire was completed in the first phase, psychological preparation was carried out for the patients before M.R.I. After their anxiety, information, and beliefs about M.R.I conduction were assessed, the intervention was carried out in three areas: Information control, Cognitive and Behavioral control (advantage of M.R.I and its positive point)
Category
Behavior
2
Description
To gauge the length of time it takes for cases, intervention is carried out regular information placed at the disposal of the control group and the intervention does not take place.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fouroozan Behrouzian
Street address
Golestan hospital, Golestan Blvd.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Forouzan Behrouzian
Street address
Golestan Hospital, Golestan Blvd
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Frouzan Behrouzian
Position
Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
fbehrouzian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mehrnaz Jalalian Larki
Position
Resident
Other areas of specialty/work
Street address
Ahvaz Golestan hospital, Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 619163115117
Fax
Email
jalalian.m@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mehrnaz Jalalian Larki
Position
Resident
Other areas of specialty/work
Street address
Ahvaz Golestan hospital, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 619163115117
Fax
Email
jalalian.m@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)