Determination of effect of ice bag on vital signs and femoral pain in patients with MI undergoing PCI
Design
This clinical trial has two groups ( intervention and control,) 30 patients in each group.
Settings and conduct
This study will be done in one of Kerman University of Medical Sciences hospital ( Shafa ).
Ice bag will be used for 20 minutes in the femoral area. Then the catheter will be removed, and the variables will be measured during and after the catheter removing.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with Myocardial infarction undergoing percutaneous
,coronary intervention, age over 18, having Iranian nationality
, alert, stability of Hemodynamic situation
Exclusion criteria:
Using sedative and analgesic drugs, emergency status and
dangerous arrhythmias, sensention to cold, having Raynaud's disease, mental and physical problems such as visual and auditory disorder, addiction to narcotic and alcohol
Intervention groups
In the intervention group, the ice bag will be used for 20 minutes in the femoral area. Then the catheter will be removed, pain and vital signs will be measured during and after the catheter removing.
Main outcome variables
-Pain
- vital sign
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151107024919N7
Registration date:2019-06-27, 1398/04/06
Registration timing:retrospective
Last update:2019-06-27, 1398/04/06
Update count:0
Registration date
2019-06-27, 1398/04/06
Registrant information
Name
Batoul Tirgari
Name of organization / entity
Kerman Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5207
Email address
b_tirgari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ice bag on vital signs and femoral region pain in patients with MI undergoing percutaneous coronary intervention
Public title
Application of ice bag on vital signs and reducing femoral region pain in patients with MI undergoing percutaneous coronary intervention
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Myocardial infarction undergoing percutaneous coronary intervention
Age over 18
Having Iranian nationality
Alert
Stability of Hemodynamic situation
Exclusion criteria:
Using sedative and analgesic drugs
Emergency status and dangerous arrhythmias
Sensention to cold
Having Raynaud's disease
Mental and physical problems such as visual and auditory disorder
Addiction to narcotic and alcohol
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method.
Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment.The block size is
determined by the researcher and should be a multiple of the number of groups (i.e., with two treatment groups, block size of either 4, 6, or 8)
The method used in this study is as follows: BABA"ABBA "AAB"BABA"BBAA" "BAAB "AAB "ABAB"BABA "AABB"BBAA"AABB "ABBA "BAAB"AABB"
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
No, 1, end of Shafa AVE., Shafa Educational Hospital
City
Kerman
Province
Kerman
Postal code
7618751151
Approval date
2018-12-10, 1397/09/19
Ethics committee reference number
IR.KMU.REC.1397.325
Health conditions studied
1
Description of health condition studied
Acute Myocardial Infarction
ICD-10 code
I21.9
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Pain
Timepoint
Before, during and after the exiting arterial catheterization
Method of measurement
Numerical Rating Scale for pain
2
Description
Vital signs
Timepoint
Before, during and after the arterial catheterization
Method of measurement
Monitor that is connected to the patient and thermometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ice bag (in the size of 15 x 10 cm and weight 250 grams, model BEYBY BASIC model NT_304 from the company Berlyan Toba) will use for 20 minutes in the femur area
Category
Other
2
Description
Control group: They will receive routine PCI care before, during and after removing cathter that would be include: immobilization and applying sand bag of affected site.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Batool tirgari
Street address
No. 1, End of Shafa Ave., Shafa Eduacational hospital.
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
b_tirgari@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/snm
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
No 2. Research and Technology Dept. ), Ibnsina Ave., Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3121 7213
Email
abpardakhty@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/vcrt
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?