aim: it is a randomized controlled trial to determine the effect of preparation package on anxiety and vital signs. inclusion criteria: elective coronary angiography for first time and willing to participation in the research, exclusion criteria: active bleeding during or after angiography and the need for cardiac and pulmonary resuscitation during angiography. participants: patients undergoing coronary angiography. sample: 100 patients undergoing coronary angiography will be randomly assigned into intervention and control groups. intervention: vital signs and then anxiety of the patients will measure in the day before angiography. the intervention group will receive a preparation package. vital signs and anxiety will measure in several time after preparation.the control group will received routine preparation.vital signs and anxiety of control group will measure in a similar pattern to the intervention group.the intervention group will receive a preparation package on the day of admission, that includes face to face education, delivering and explaining the content of the educational pamphlet, playing educational video about angiography process with verbal explanation and introduction angiography unit to patients. control group will receive routine preparation.
main outcome: change in vital signs and anxiety
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042313102N1
Registration date:2013-07-06, 1392/04/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-06, 1392/04/15
Registrant information
Name
Tayebeh Moradi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
t-moradi@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of preparation package on anxiety and vital signs of patients undergoing coronary angiography in Beheshti hospital in 2013
Public title
the effect of preparation package on anxiety and vital signs
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria:elective coronary angiography for first time؛ willing to participation in the research؛ be oriented؛ be able to read and understand persion؛ without unknown mental disorder؛ aged between 30-70
exclusion criteria: active bleeding during or after angiography؛ the need for cardiac and pulmonary resuscitation during angiography
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ehics commitee of Kashan University of medical sciences
Street address
Kashan University of Medical Science, Gotbe ravandi road, Kashan, Iran
City
Kashan
Postal code
Approval date
2013-05-18, 1392/02/28
Ethics committee reference number
پ/618/1/5/29
Health conditions studied
1
Description of health condition studied
angiography
ICD-10 code
I20.0
ICD-10 code description
Unstable angina
Primary outcomes
1
Description
anxiety
Timepoint
before intervention
Method of measurement
Spielberger anxiety Scale
2
Description
vital signs
Timepoint
before intervention
Method of measurement
using a heart monitor
Secondary outcomes
1
Description
change in anxiety
Timepoint
after intervention
Method of measurement
Spielberger anxiety Scale
2
Description
change in vital signs
Timepoint
after intervention
Method of measurement
using a heart monitor
Intervention groups
1
Description
the intervention group will receive a preparation package on the day of admission, that includes face to face education, delivering and explaining the content of the educational pamphlet, playing educational video about angiography process with verbal explanation and introduction angiography unit to patients.
Category
Behavior
2
Description
the control group will receive routine preparation.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital in kashan
Full name of responsible person
Street address
City
kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr. GolamAli Hamidi
Street address
Vice chancellor for research, Kashan University of Medical Sciences, Ghotbe ravandi Bolvard
City
kashan
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, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Tayebeh Morady
Position
Student in Master of Science in Nursing
Other areas of specialty/work
Street address
Medical-Surgical Nursing Department ,Faculty of nursing and Midwifery, Kashan University of Medical Sciences, Gotbe ravandi Bolvard
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
tmorady67@yahoo.comt-moradi@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Adib-Hajbaghery
Position
PHD
Other areas of specialty/work
Street address
Medical-Surgical Nursing Department, Faculty of nursing and Midwifery, Kashan University of Medical Sciences, Gotbe ravandi Bolvard
City
Kashan
Postal code
Phone
+98 36 1555 6633
Fax
Email
adib1344@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Tayebeh Moradi
Position
Student in Master of Science in Nursing
Other areas of specialty/work
Street address
Medical-Surgical Nursing Department ,Faculty of nursing and Midwifery, Kashan University of Medical Sciences, Gotbe ravandi Bolvard
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
tmorady67@yahoo.comt-moradi@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)