This randomized controlled experimental study aimed to examine the effect of cold application after transradial coronary angiography on pain, bruising (ecchymosis), and comfort levels in patients. The study was conducted in the coronary intensive care unit of a university hospital in Istanbul, Türkiye, between July 2023 and July 2024. A total of 104 adult patients who underwent transradial coronary angiography were randomly assigned to intervention (cold application) and control groups using a computer-based randomization method. In the intervention group, cold packs were applied to the wrist starting immediately after admission to the coronary intensive care unit. Cold application was performed for 15 minutes every hour until the TR band was removed and then every 2 hours for 15 minutes afterward. The control group received routine care without cold application. Pain levels were assessed hourly using the Numerical Rating Scale (NRS). Bruising was monitored by measuring hematoma size, and patient comfort was evaluated at two time points: at admission and when the TR band was removed, using the Early Postoperative Comfort Scale. The primary outcomes were pain, ecchymosis, and comfort levels. The secondary outcome was the duration of TR band placement. The study aimed to determine whether cold application helps reduce pain and bruising and improves comfort after transradial coronary angiography.
This randomized controlled experimental study aimed to determine the effect of cold application after transradial coronary angiography on patients' pain, bruising (ecchymosis), comfort levels, and the duration of TR band placement. The study was conducted in the coronary intensive care unit (ICU) of a university hospital in Istanbul, Türkiye, between July 2023 and July 2024. A total of 104 adult patients who underwent transradial coronary angiography and were monitored with a TR band for bleeding control were included. Patients were randomly assigned to intervention (cold application) and control groups using a computer-generated simple randomization method. In the intervention group, cold packs prepared by placing gel compresses in a freezer for 2-3 hours were applied to the wrist area. Cold application started immediately after admission to the coronary ICU and was performed for 15 minutes every hour until the TR band was removed. After the TR band was removed, cold application continued every 2 hours for 15 minutes. The control group received routine post-procedural care without cold application. Pain levels were assessed hourly using the Numerical Rating Scale (NRS). Bruising was monitored by measuring the hematoma size using a ruler and marking its borders on the skin to track changes. Patient comfort was evaluated twice: at ICU admission and when the TR band was removed, using the Early Postoperative Comfort Scale (EPCS). Laboratory values (aPTT, PT, hemoglobin, hematocrit, platelets) were collected from patients' routine clinical results before and after the procedure. The primary outcomes of the study were pain, ecchymosis, and comfort levels. The secondary outcome was the duration of TR band placement. The study hypotheses were as follows: Cold application after transradial coronary angiography is effective in reducing pain levels. Cold application reduces the development of ecchymosis. Cold application improves patient comfort. Cold application shortens the duration of TR band placement. The study aimed to provide evidence on the effectiveness of a simple, non-pharmacological intervention - cold application - to improve post-procedural comfort and reduce complications in patients undergoing transradial coronary angiography.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
104
Protocolized hemostasis management following transradial coronary angiography included TR Band balloon deflation by 2-3 mL every 15 minutes during the first hour, followed by deflation at 30-minute intervals until the balloon was fully emptied. If bleeding occurred, the withdrawn air was immediately reinjected to restore hemostasis. The TR Band was removed once bleeding had stopped, and a sterile gauze dressing was applied. Participants received routine monitoring for bleeding and vascular complications. No cold application was administered.
Gel cold packs, pre-frozen for 2-3 hours, were applied to the wrist at the transradial puncture site for 15 minutes every hour, beginning immediately after admission to the coronary intensive care unit and continuing until TR Band removal. Cold application was administered in addition to standard post-procedural TR Band care and did not extend beyond the 6-hour follow-up period.
Bezmialem Vakif University Hospital - Coronary Intensive Care Unit
Istanbul, Turkey (Türkiye)
Pain intensity at the radial access site (NRS, 0-10)
Pain scored using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst pain). Scores recorded at scheduled checks (hourly during TR band monitoring). Primary analysis will compare group differences in mean pain and change in pain from admission to TR band removal.
Time frame: Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours)
Hematoma occurrence
Presence of hematoma at the radial access site assessed hourly (yes/no); hematoma \>5 cm in diameter classified as a complication per Kristin Swain's checklist.
Time frame: Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours)
Hematoma size
Presence of hematoma at the radial access site assessed hourly (yes/no); hematoma \>5 cm in diameter classified as a complication per Kristin Swain's checklist.
Time frame: Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours)
Ecchymosis occurrence
Presence of ecchymosis at the radial access site assessed hourly by visual inspection (yes/no).
Time frame: Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours)
Bleeding occurrence
Presence of bleeding at the radial access site assessed hourly (yes/no).
Time frame: Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours)
Bleeding amount
Volume of bleeding quantified in milliliters when present.
Time frame: At ICU admission (baseline) and at TR band removal (up to 6 hours)
Patient comfort (EPCS)
Comfort evaluated with the Early Postoperative Comfort Scale (EPCS), a 24-item scale with each item scored 1-6 (higher scores indicate better comfort). Total scores range from 24 to 144. Primary analysis compares group differences and within-group change from ICU admission to TR band removal.
Time frame: At ICU admission (baseline) and at TR band removal (up to 6 hours)
Oedema occurrence at the radial access site
Presence of oedema at the puncture site assessed hourly by visual inspection and clinical examination (yes/no).
Time frame: Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours)
TR Band dwell time
Duration of TR Band placement, calculated as the interval between ICU admission and TR Band removal, measured in hours.
Time frame: From ICU admission after the procedure until TR band removal (up to 6 hours)
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