The aim of this study was to determine the effect of premedication on the perception of ''anxiety'','' pain ''and '' hemodynamic status'' in patients who underwent coronary angiography in Ganjavian Dezful Hospital in 1390. method: The study was designed as a randomized and single- blind trial and all patients gave written informed consent. Following consent a total of 102 patients who scheduled to undergo elective coronary angiography were randomized in to three equal groups (each group 34 patients) based on days of week. The inclusion criteria were Having coronary angiography for the first time; Patients aged 30-70 years; Having just coronary angiography without right heart catheterization; Having no history of invasive procedures before angiography such as Trans Esophageal Echocardiogram.The Exclusion criteria were: History of recent myocardial infarction( during last week); History of severe heart failure, Heart valves disease or congenital heart disease; Hemodynamic istability; History of severe anxiety.Patients sensitivity to pain was measured by pricking the heels with a needle at a distance 5 cm of them.The patients anxiety was measured 8 to 12 hours and half an hour before coronary angiography by VAS criteria.Hemodynamic status was recorded at the same time too.The first group( group A) received 4 mg intravenous Chlorpheniramine and 100mg IV Hydrocortizon, the second group (group B) received 5mg IV Diazepam and 100mg IV Hydrocortizon, the third group (group C) received 2mg IV Normalsalin solution and 100mg IV Hydrocortizon 30 to 60 minutes prior to procedure.Then the patients'' anxiety'' and'' pain'' were determined by asking a question during procedure and the level of'' anxiety'' and pain were measured by VAS criteria. The patients hemodynamic were recorded every 5 minutes for four times.The patients pain level was measured at arrival time to the ward and 2-4-6 after coronary angiography by VAS criteria.The hemodynamic status was recorded every 15 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012071010235N1
Registration date:2012-12-31, 1391/10/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-31, 1391/10/11
Registrant information
Name
Hamideh Mashalchi
Name of organization / entity
Ahvaz Jondishapor University of Medical Sciences,Ahvaz Jondishapor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 65 2235 6552
Email address
hamidehmashalchi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapor University of Medical Sciences and Vice chancellor for research, Arvand University of Medical Sciences
Expected recruitment start date
2012-05-30, 1391/03/10
Expected recruitment end date
2012-06-30, 1391/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of premedication on'' anxiety'','' pain'' and'' hemodynamic status'' of patients undergoing coronary angiography Ganjaviyan Hospital Dezful in 1390: a blind randomized clinical trial interpretations
Public title
The effect of premedication on'' anxiety'','' pain'' and'' vital signs'' of patients with coronary angiography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having coronary angiography for the first time ; Patients aged 30-70 years ; Having just coronary angiography without right heart catheterization ; Having no history of invasive procedures before angiography such as Trans'' Esophageal Echocardiogram''.
Exclusion criteria: History of recent myocardial infarction( during last week); History of severe heart failure, Heart valves disease or congenital heart disease; Hemodynamic'' istability'' ; History of severe anxiety.
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur of Medical Sciences ethics committee.
Street address
Research Vice-Chancellor of Ahvaz Jundishapur University of Medical Sciences, Golestan boulevard , university campus
City
Ahvaz
Postal code
6135715794
Approval date
2012-05-26, 1391/03/06
Ethics committee reference number
495-ETH
Health conditions studied
1
Description of health condition studied
cardiac catheterization
ICD-10 code
I20
ICD-10 code description
Angina pectoris
Primary outcomes
1
Description
Anxiaty severity
Timepoint
8-12 hours and half an hour before coronary angiography and during coronary angiography.
Method of measurement
Whether having anxiety by asking a question and anxiety level by VAS criteria.
2
Description
Pain severity
Timepoint
During Angiography and after in time of arrival and 2,4,6 hours after coronary angiography
Method of measurement
Whether Having pain by asking a question and pain level by VAS criteria.
3
Description
Hemodynamic status
Timepoint
8-12 hours and half an hour before coronary angiography and every 5 minutes during procedure then every 15 minutes after procedure.
Method of measurement
By Control pulse, respiration, temperature, systolic and diastolic blood pressure
Secondary outcomes
1
Description
Measure rate sensitivity to pain
Timepoint
One hour before injection of the premedication
Method of measurement
The heels with a needle at a distance 5 cm
Intervention groups
1
Description
In group A the hemodynamic status and anxiety level were recorded 8 to 12 hours and half an hour prior to coronary angiography, then they recieved 4mg IV Chlorpheniramine and 100mg IV Hydrocortizon, 0/5 to 1 hour before procedure as premedication. The anxiety level and pain level and hemodynamic status were recorded every 5 minutes during coronary angiography.The pain level was measured at arrival time to ward and 2-4-6 hours after procedure, and the hemodynamic status was recorded every 15 minutes.
Category
Treatment - Drugs
2
Description
In group B the hemodynamic status and anxiety level were recorded 8 to 12 hours and half an hour prior to coronary angiography, then they recieved 5mg IV Diazepam and 100mg IV Hydrocortizon, 0/5 to 1 hour before procedure as premedication. The anxiety level and pain level and hemodynamic status were recorded every 5 minutes during coronary angiography.The pain level was measured at arrival time to ward and 2-4-6 hours after procedure, and the hemodynamic status was recorded every 15 minutes.
Category
Treatment - Drugs
3
Description
In group C the hemodynamic status and anxiety level were recorded 8 to 12 hours and half an hour prior to coronary angiography, then they recieved 2mg IV Normalsalin and 100mg IV Hydrocortizon, 0/5 to 1 hour before procedure as premedication. The anxiety level and pain level and hemodynamic status were recorded every 5 minutes during coronary angiography.The pain level was measured at arrival time to ward and 2-4-6 hours after procedure, and the hemodynamic status was recorded every 15 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gangavian Hospital in Dezful
Full name of responsible person
Hamideh Mashalchi
Street address
Dezful, Andimeshk road
City
Dezful
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice-Chancellor of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Mostafa Feghhi
Street address
Research Vice-Chancellor of Ahvaz Jundishapur University of Medical Sciences, Golestan boulevard , university campus
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice-Chancellor of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Arvand International Division, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Javaheri
Street address
Arvand International Division, International Airport, Abadan
City
Abadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arvand International Division, Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
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
Medical and Health Services, Ahwaz Jondi Shapur - The International Arvand
Full name of responsible person
Fakharzadeh Leyla
Position
Master and member of the Faculty of Nursing
Other areas of specialty/work
Street address
Abadan, Taleghani Hospital, Nursing Abadan
City
Abadan
Postal code
post box517
Phone
00
Fax
+98 63 1333 5363
Email
Fakharzadehl@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical and Health Services, ''Ahwaz Jondi Shapur'' - the unit International Arvand
Full name of responsible person
Fakharzadeh Leyla
Position
Master and member of the Faculty of Nursing
Other areas of specialty/work
Street address
Abadan Faculty of Nursing,''Taleghani Hospital'','' Abadan''
City
Abadan
Postal code
post box517
Phone
00
Fax
+98 63 1333 5363
Email
Fakharzadehl@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapor University of Medical Sciences,''Ahvaz Jondishapor'' University of Medical Science
Full name of responsible person
Hamideh Mashalchi
Position
Nursing student
Other areas of specialty/work
Street address
Mahshahr, ''Phase 2'','' Roshdiyeh Blvd'','' Building Eram1''