Comparison of Effects of two Pharmacological and Non-pharmacological methods on the Vasospasm, Pain, and Anxiety of Patients undergoing Radial Angiography
The aim of the study is the comparative assessing of two pharmaceutical and nonpharmaceutical methods on vasospasm, pain, and anxiety of patients undergoing of radial angiography. The study is a clinical trial with the control group and random design. The main inclusion criteria are having the 15-65 years old and not existing critical situation and not using sedatives. The main exclusion criteria are appearing of serious complications during angiography and existing contradictions in getting pethidine. The sample size is 30 in each group and in all three groups is 90 (2 intervention groups and 1 control groups) that they will be allocated randomly by blocking method among three groups. The first random allocation will be done by lottery. Two interventions will be included the followings: in group 1 Benson relaxation technique will be educated and done during 15-20 minutes and in the group 2, the 25 mg pethidine was infused intravenously half an hour before angiography. At control group won’t be done any intervention. Assessment and intervention will be started the half an hour before angiography. The pain and anxiety outcomes will be assessed in half an hour before and in the end of angiography. Also during angiography, vasospasm, and pain will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071324312N2
Registration date:2017-10-15, 1396/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Fataneh Ghadirian Baharanchi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4311
Email address
ghadirian.fataneh@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Baqiyatallah University of Medical Sciences
Expected recruitment start date
2016-10-25, 1395/08/04
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effects of two Pharmacological and Non-pharmacological methods on the Vasospasm, Pain, and Anxiety of Patients undergoing Radial Angiography
Public title
The effects of Pharmacological and Non-pharmacological methods on the Radial Artery Spasm in Radial Angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Allen positive test; Age between 15-65 years; No previous history of radial angiography; Having no cognitive impairment before and after the intervention; Having no emergency condition; Having no extra anxiety in patient; Having satisfaction; lack of hearing impairment; Having at least reading and writing skills; No having used tranquilizers during the last 8 hours"
Exclusion criteria: A history of sedative medicine; History of neurological and respiratory problems; History of paralysis and paresthesia in patients; History of substance abuse or similar drugs such as oral methadone; The occurrence of any hematoma and radial arterial perforation during radial angiography; History of liver & kidney disorders
Age
From 14 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Nosrati Alley, South Sheykhbahaee St., Mollasadra St.,
City
Tehran
Postal code
14155-6427
Approval date
2016-10-16, 1395/07/25
Ethics committee reference number
IR.BMSU.REC.1395.94
Health conditions studied
1
Description of health condition studied
Vasospasm
ICD-10 code
I73.9
ICD-10 code description
Peripheral vascular disease, unspecified
Primary outcomes
1
Description
Radial Artery Spasm
Timepoint
During Angiography
Method of measurement
Radial Vasospasm Scale
Secondary outcomes
1
Description
Anxiety Score
Timepoint
Before relaxation intervention or pethidine injection and After angiography
Method of measurement
Beck Anxiety Inventory (BAI), Visual Analog Scale anxiety (VAS)
2
Description
Pain Severity
Timepoint
Before relaxation intervention or pethidine injection and After angiography
Method of measurement
Visual Analog Scale for pain
Intervention groups
1
Description
Intervention group 1: It will be administrated 25 mg blouse Pethidine to the research samples by intravenous injection in half an hour before angiography.
Category
Treatment - Drugs
2
Description
intervention group 2: It will do Benson relaxation method for 15-20 minutes at half an hour before angiography. The patient will be requested to loose and relax his/her muscles and while Breathing out of the nose and exhale through the mouth, repeat comforting words and think of other topics.
Category
Treatment - Other
3
Description
Control group: It will not do any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah (AJ) Hospital
Full name of responsible person
Yasser Moazami Goodarzi
Street address
Nosrati Alley, South Sheykhbahaee St., Mollasadra St.,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Alireza Alishiri
Street address
Nosrati Alley, South Sheykhbahaee St., Mollasadra St.,
City
Tehran
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, Baqiyatallah University of Medical Sciences