Effect of new planning care on back pain and vascular complication after coronary angiography in the post angiography ward of Rasht (heshmat Teaching hospital), 2010
The aim of this study is to assess the effect of new planning care on back pain and vascular complications after cardiac catheterization. A total of 126 patients who have undergone a nonemergency diagnostic cardiac catheterization via the femoral artery are randomly assigned into intervention or control group. The patients in the intervention group are positioned at the supine position during the first hour, at the position with head of the bed elevated by 30-45 degrees during the second hour, and at the position with head of the bed elevated by 45 degrees during the third hour, at the right and left lateral positions, equally. At the fourth hour, the patients are allowed to be out of bed after a while sitting on the edge of the bed. The sand bags are taken away two hours later. The patients in the control group will receive routine care included bed rest for 8–10 hours with immobilizing the affected leg during bed rest as well as application of a 5 kg sandbag for four hours. Primary outcome measures are incidence of vascular complications and low back pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010194971N1
Registration date:2010-12-24, 1389/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-24, 1389/10/03
Registrant information
Name
Mohamadtaghi Moghadabnia
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 2088
Email address
moghadamnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Guilan University of Medical Sciences
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-02-04, 1389/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of new planning care on back pain and vascular complication after coronary angiography in the post angiography ward of Rasht (heshmat Teaching hospital), 2010
Public title
Effect of new planning care on back pain and vascular complication after coronary angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: No known coagulation abnormality, femoral approach for the procedure, age between 18-80 years, usage of the arterial sheath 6-F size, single puncture of the femoral artery, signing written informed consent
Exclusion criteria: diastolic or systolic blood pressure higher than 110 and 190 mmHg, presence of low back pain, presence of any complications developing during cardiac catheterization, arrhythmias, unconsciousness, deep vein thrombosis before the procedure
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
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
Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences, opposite of Alzahra Hospital., Namjoo ave, Rasht, Guilan, Iran
City
Rasht
Postal code
Approval date
2010-09-28, 1389/07/06
Ethics committee reference number
10229
Health conditions studied
1
Description of health condition studied
back pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Vascular complication
Timepoint
Points included the time immediately after coming to the post catheterization ward, at 1 h(any30 minute), 2 h, 3 h(any30 minute), 4 h,6h.10h after cardiac catheterization and finally the next morning.
Method of measurement
The borders of hematoma measures by the ruler with Centimeter and bleeding measures by balance with Milliliter.Insignificant bleeding defines as blood loss estimated as less than 100 mL and Insignificant haematoma absence of haematoma, or a haematoma less than or equal to 5 cm in width. Significant bleeding defines as blood loss estimate as equal or greater than 100 mL. Significant hematoma also considering when a haematoma occlude width equal to or greater than 5 cm.
2
Description
Back pain
Timepoint
Points included the time immediately after coming to the post catheterization ward, at 1 h, 2 h, 3 h, 4 h, 6h, and 10 h after cardiac catheterization and finally the next morning morning
Method of measurement
visual analogue scales (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients are positioned at the supine position during the first hour, at the position with head of the bed elevated by 30-45 degrees during the second hour, and at the position with head of the bed elevated by 45 degrees during the third hour, at the right and left lateral positions, equally. At the fourth hour, the patients are allowed to be out of bed after a while sitting on the edge of the bed. The sand bags are taken away two hours later.
Category
Prevention
2
Description
Control group: The patients will receive routine care included bed rest for 8–10 hours with immobilizing the affected leg during bed rest as well as application of a 5 kg sandbag for four hours.