This randomized control clinical trial will be conducted on 62 cardiac catheterization patients in Vasei hospitals in Sabzevar. This study is planned to evaluate the effect of Guided Imagery on pain, anxiety and some hemodynamic factors in patients undergoing coronary angiography. the trail will be performed in 62 patients between 35 to 68 years of age Inclusion criteria: Aged between 35to 68 years; state anxiety scale less than 64 and the Trait Anxiety scale of less than 62; can be reading and writing Exclusion criteria: Reluctance to continue participating in the study; Death . After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 32 patients in experimental and 32 in control group. The necessary data will collected through a demographic information sheet, a hemodynamic variable sheet, the STAI anxiety questionnaire and a pain scale. Before the treatment, the participants in both groups will ask to fill out the demographic information sheet. In addition, they will require to answer the hemodynamic sheet both before and after the treatment, and the STAI questionnaire just after the treatment. The numerical pain scale will give to the subjects in both groups just after angiography procedure. The experimental group subjects will ask to listen to a Guided Imagery CD for 18 minutes one hour before the angiography procedure. Before the subjects of both groups will go the angiography room, their anxiety and hemodynamic will measure and record.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010916148N1
Registration date:2014-07-04, 1393/04/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-04, 1393/04/13
Registrant information
Name
Samira Foji
Name of organization / entity
Sabzevar University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 57 1265 4874
Email address
foji.s1@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2013-08-22, 1392/05/31
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Guided Imagery on pain, anxiety and some other hemodynamic factors in patients undergoing coronary angiography.
Public title
Effect of Guided Imagery on pain, anxiety and some other hemodynamic factors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age should be between 35 years to 68 years,The state anxiety scale less than 64 and the Trait Anxiety scale of less than 62,can be reading and writing.
Exclusion criteria :
Reluctance to continue participating in the study, death.
Age
From 35 years old to 68 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
School of Nursing and Midwifery، next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Approval date
2013-08-19, 1392/05/28
Ethics committee reference number
92.11.medsab.Rec
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention ، After intervention
Method of measurement
STAI Anxiety questionnaire
2
Description
Hemodynamic Factors
Timepoint
Both before and after the intervention
Method of measurement
Manometer
3
Description
Pain
Timepoint
After Angiography
Method of measurement
numerical pain scale
Secondary outcomes
empty
Intervention groups
1
Description
The experimental group subjects will ask to listen to a Guided Imagery CD for 18 minutes one hour before the angiography procedure and they will require to answer the hemodynamic sheet both before(morning of angiography, an hour before angiography) and after the Intervention, and the STAI questionnaire Before( an hour angiography) and after the Intervention. The numerical pain scale will give to the subjects in experimental groups just after angiography procedure.
Category
Behavior
2
Description
NO intervention in control group and thy will require to answer the hemodynamic sheet both before ( morning of angiography, an hour before angiography) and after the Intervention, and the STAI questionnaire Before( morning of angiography) and after the intervention. The numerical pain scale will give to the subjects in control groups just after angiography procedure
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Vasei Hospital
Full name of responsible person
Samira Foji
Street address
Vasei Hospital; Sabzevar
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Moosa Reza Tadayonfar
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Samira Foji
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 57 1226 4404
Fax
Email
samirafoji@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Moosa Reza Tadayonfar
Position
MSc./Member of Faculty
Other areas of specialty/work
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sbzevar
Postal code
Phone
+98 57 1226 4404
Fax
Email
mtadayonfar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Samira Foji
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
Fax
Email
samirafoji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)