An investigation of local forearm heating on the pain intensity and hemorrhage of patients undergoing cardiac catheterization via radial artery at the time of withdrawal sheath: A pilot study
Determining of the effect of local forearm heating on the pain intensity and hemorrhage of patients Undergoing Cardiac Catheterization via Radial Artery at the Time of Withdrawal Sheath
Design
This study was designed as a phase 2 clinical trial with a control group of 50 patients in each group, in a double-blind, randomized manner, which CREATE A RANDOMISATION LIST program was used for randomization.
Settings and conduct
This study was conducted on 100 patients who are candidates for angiography and coronary angioplasty through the radial artery in the angiography department of Ayatollah Rouhani Hospital in Babol. For blinding, the sheaths were removed by people other than the present researcher and for data analysis, the studied groups were marked with alphabet labels.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 65 years, indication of cardiac catheterization, non-emergency of cardiac catheterization. Exclusion criteria: history of previous catheterization through the radial artery, more than 3 catheter changes during the procedure, more than 3 attempts to puncture the artery
Intervention groups
In the intervention group, local heating of the hand with the Warm Touch device is performed for 3 minutes with hot air that has a temperature of 35-45 degrees centigrade from a distance of 20-30 cm. In the control group, the sheath is removed without any intervention.
Main outcome variables
Pain intensity; Bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220521054951N1
Registration date:2022-11-17, 1401/08/26
Registration timing:retrospective
Last update:2022-11-17, 1401/08/26
Update count:0
Registration date
2022-11-17, 1401/08/26
Registrant information
Name
Atefeh Shamsian
Name of organization / entity
Shahid Rajaie Cardiovascular, Medical & Research Center
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8301
Email address
shamsian1986@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-20, 1400/12/29
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An investigation of local forearm heating on the pain intensity and hemorrhage of patients undergoing cardiac catheterization via radial artery at the time of withdrawal sheath: A pilot study
Public title
An investigation of Local Forearm Heating on the Pain Intensity and hemorrhage of Patients Undergoing Cardiac Catheterization via Radial Artery at the Time of Withdrawal Sheath
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ability and willingness to cooperate with the researcher
ability to speak and understand Persian language
age of 18 to 65 years
indication of cardiac catheterization through the radial artery
no emergency for cardiac catheterization
no history of paralysis and hemiparesis
no surgery on the hand
no History of peripheral vascular diseases (diabetes) or peripheral neuropathy
no mastectomy
no vascular fistula in patients with kidney diseases
Exclusion criteria:
Patients who have undergone more than one radial artery catheterization
patients who have had catheter replacement more than 3 times
patients who have been punctured more than 3 times
Age
From 18 years old to 65 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
After block randomization with a size of 6, the patients are divided into two groups of 30 intervention and control (by CREATE A RANDOMISATION LIST computer program).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Rajaei Cardiology Research Training Center
Street address
Tehran - Wali Asr St. (Aj) - next to Mellat Park - Niayesh Corner of Shahid Rajaei Cardiovascular Training, Research and Treatment Center
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2022-07-15, 1401/04/24
Ethics committee reference number
IR.RHC.REC.1401.049
Health conditions studied
1
Description of health condition studied
Patients undergoing cardiac catheterization through the radial artery
ICD-10 code
Y84.0
ICD-10 code description
Cardiac catheterization as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Pain intensity
Timepoint
When leaving the sheet and an hour after that
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Hemorrage
Timepoint
When leaving the sheet and an hour after that
Method of measurement
view
Intervention groups
1
Description
Intervention group: Local heating of the forearm for 3 minutes by the Warm Touch device, COVIDEN-2013), before removing the arterial sheath.