In this randomized clinical trial to determine The effect of psychologic preparation to reduce anxiety associated with cardiac catheterization.Participants had no past psychiatry history and Previous angiography, they referred for angiography to Golestan Ahwaz Hospital at 2012, 40 were enrolled and randomly assigned into two groups; intervention group whom received psychological preparation and control group.. First step was completing demographic questionnaire and Hamilton Anxiety Scale the day before cardiac catheterization in both groups. Then psychological preparation(Information control, cognitive control and behavioral control) for cardiac catheterization was performed for intervention group. The Hamilton Anxiety Scale at 2 hours before and 4 hours after cardiac catheterization was completed for both and Their anxiety levels were measured. The primary outcome was anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101011071N1
Registration date:2014-02-13, 1392/11/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-13, 1392/11/24
Registrant information
Name
Saeed Ansari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 0590
Email address
ansari.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapur University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psychologic preparation to reduce anxiety associated with cardiac catheterization
Public title
The effect of psychologic preparation to reduce anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age 80-35 years; Speaking Farsi; Ability to communicate verbally; No history of previous cardiac catheterization.
Exclusion criteria: Dementia; Mental retardation; Severe physical difficulty; History of marked psychiatric disorder; Non cooperation.
Age
From 35 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jundishapur University of Medical Sciences
Street address
2nd floor, School of Medicine Ahvaz Jundishapur University of Medical Sciences, Golestan BLV, Ahvaz
City
Ahvaz
Postal code
15794 – 61357
Approval date
2012-08-11, 1391/05/21
Ethics committee reference number
ETH-562
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F40.9
ICD-10 code description
Phobic anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety level
Timepoint
24 hours before and 2 hours before and 4 hours after cardiac catheterization
Method of measurement
Hamilton Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
in Intervention group: 3 of the intervention include: 1) modifying patient information, 2) cognitive control treatment will be carried out (eg patients regarding the positive aspects of practice rather than an emphasis on the aspect of unpleasant n) 3) control behavior, such as relaxation training, distraction techniques
Category
Behavior
2
Description
Undisclosed content in the control group (properties of fruits and vegetables) for the study were placed in their possession.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Ahwaz Hospital
Full name of responsible person
Saeed Ansari
Street address
Department of Psychiatry, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Saeed Ansari
Street address
Department of Psychiatry, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Saeed Ansari Dezfouli
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Department of Psychiatry, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1374 3038
Fax
+98 37430380611
Email
DR.SAD60@YAHOO.COM/ANSADRI.S@AJUMS.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Forouzan Behrouzian
Position
psychiatrist
Other areas of specialty/work
Street address
Department of Psychiatry, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1374 3038
Fax
+98 37430380611
Email
Fbehrouzian@gmail.com/DR.SAD60@YAHOO.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
Saeed Ansari Dezfouli
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Department of Psychiatry, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1374 3038
Fax
+98 37430380611
Email
DR.SAD60@YAHOO.COM/ANSADRI.S@AJUMS.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)