Assessing the effect of local cold application over femoral sheath insertion site on low back pain and vascular complications of patients undergoing coronary angiography referred to Dr.Heshmat Educational and remedial center in Rasht in 2018-2019
determine Assessing the effect of local cold application over femoral sheath insertion site on low back pain and vascular complications of patients undergoing coronary angiography referred to Dr.Heshmat Educational and remedial center in Rasht
Design
This study is a randomized controlled clinical trial.The samples size is 110. Four random blocks were randomly allocated in two groups of intervention (cold pack) and control group, which is routine of the hospital (sand bag).
Settings and conduct
the study is conducted in patients undergoing coronary angiography referred to Dr.Heshmat Hospital in Rasht. Intervention group(cold pack)
after covered with clear dressing a cold pack during 2 hours Will be applied on the place.Control group(sand bag):which is routine of the hospital included the use of sand bags is 3-4 kg to 4 hours
Participants/Inclusion and exclusion criteria
The inclusion criteria:Signing written informed consent، Older than 18 years old Not sensitive to cold، No active bleeding in the femoral area ، Not experiencing lower back pain ، Ability to understand persian language، No disorders psychiatric and seeing or hearing and time and place orientation ،No history of treatment with thrombolytic drugs less than 6 monts، natural range of coagulation tests results،No use sedative duration 24 hourse
exclusion criteria : The occurrence of conditions that may lead to impairment in the care process، diastolic or systolic blood pressure higher than 110 and 190 mm Hg
Intervention groups
Intervention group(cold pack): immediately after covered with clear dressing، a cold pack with a temperature of 15 to 18 °C during 2 hours( any period for 20 minutes with 10 minute intervals) Will be applied on the place
Control group(sand bag): receive routine care included the use of sandbags is 3-4 kg to 4 hours
Main outcome variables
vascular complications and low back pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180701040297N1
Registration date:2019-01-24, 1397/11/04
Registration timing:registered_while_recruiting
Last update:2019-01-24, 1397/11/04
Update count:0
Registration date
2019-01-24, 1397/11/04
Registrant information
Name
Nazila Javadi-Pashaki
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 2088
Email address
n.javadi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-04-18, 1398/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of local cold application over femoral sheath insertion site on low back pain and vascular complications of patients undergoing coronary angiography referred to Dr.Heshmat Educational and remedial center in Rasht in 2018-2019
Public title
Assessing the effect of local cold application over femoral sheath insertion site on low back pain and vascular complications of patients undergoing coronary angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Signing written informed consent
Older than 18 years old
Perform angiography via femoral artery
Not sensitive to cold
No active bleeding in the femoral area during the procedure and before the catheter withdrawal
Not experiencing lower back pain before hospitalization
Ability to understand persian language
No psychiatric disorders
No any problems with seeing or hearing and proper time and place orientation
No history of treatment with thrombolytic drugs and bleeding disorder for less than 6 monts
Having a natural range of coagulation tests results in a pre-angiographic case
No use sedative duration 24 hourse
Exclusion criteria:
The occurrence of any conditions that may lead to impairment in the care process
diastolic or systolic blood pressure higher than 110 and 190 mm Hg
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Four random blocks were randomly allocated in two groups of intervention (cold pack) and control group, which is routine of the hospital (sand bag). At the beginning of the study, 41 random blocks are selected based on different patches. In this random block, a lacquer envelope They are placed in the heart research center of Dr. Heshmat Hospital in Rasht. On the basis of daily visits, after the study, the blocks are hidden from the envelope, and according to the corresponding block of the day, patients are assigned randomly in one of the intervention groups and the group.
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 Guilan University of Medical Sciences
Street address
Eastern Shahid Beheshti Boulvard, Vice Chancellor for research of Guilan University of Medical Sciences
City
Rasht
Province
Guilan
Postal code
93345-41938
Approval date
2018-12-16, 1397/09/25
Ethics committee reference number
IR.GUMS.REC.1397.340
Health conditions studied
1
Description of health condition studied
Angiography
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Vascular complication
Timepoint
Immediately after covered with clear dressing every 15 minute in first hour every 30 minute in the second hour and every hour to six hours
Method of measurement
A mount of bleeding is measured with weight of blood loaded gauze by balance with Milliliter. The borders of hematoma measures pulpable mass on angiography puncture site which measered by teransparent ruler and ecchgmosis any color change (blue purple)considered to be.
Secondary outcomes
1
Description
Back pain
Timepoint
Immediately after covered with clear dressing ،4،6 and 24 after angiography procedure
Method of measurement
Visual analogue scales (VAS)
Intervention groups
1
Description
Intervention group: The patients in the intervention group are، immediately after covered with clear dressing، a cold pack with a temperature of 15 to 18 °C during 2 hours( any period for 20 minutes with 10 minute intervals) Will be applied on the place
Category
Prevention
2
Description
Control group: The patients will receive routine care included the use of sandbags is 3-4 kg to 4 hours
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat Teaching Hospital
Full name of responsible person
Nazila Javadi
Street address
Dr. Heshmat Rasht Hospital, Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
n.javadip@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Deputy of Guilan University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Namjou St., shahid siadati .,Research and Technology Deputy of Guilan University of Medical Sciences