Coronary Artery Disease
Conditions
Keywords
Transradial angiography, TR band, cold application, pain management, comfort level
Brief summary
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.
Detailed description
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.
Interventions
OTHERStandard Post-Procedural TR Band Care
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.
OTHERCold Application
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.
Sponsors
Bezmialem Vakif University
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Not applicable. The study was open-label.
Intervention model description
Participants were randomly allocated in a 1:1 ratio to one of two parallel groups. The control group received standard post-procedural TR Band care without cold application. The intervention group received standard care plus intermittent cold application to the wrist. Both groups were followed concurrently for up to 6 hours until TR Band removal.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Receiving care in the coronary ICU during the study period * Underwent elective transradial coronary angiography * Age ≥ 18 years * Haemodynamically stable * Conscious and able to communicate, without paresis * Baseline pain score ≥ 3 at ICU admission (0 hour) on the Numerical Rating Scale (0-10) * No pre-existing hematoma or ecchymosis at the puncture site * Platelet count within the institutional reference range * TR Band used for haemostasis after the procedure
Exclusion criteria
* Femoral or brachial arterial access used for coronary angiography * Local infection or skin lesion at the puncture site * Known coagulopathy, documented coagulation disorder, or active bleeding * Undergoing an emergency procedure * Loss of consciousness or inability to communicate * Baseline pain score \< 3 at ICU admission (0 hour) on the Numerical Rating Scale (0-10)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity at the radial access site (NRS, 0-10) | Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours) | 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. |
| Hematoma occurrence | Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours) | 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. |
| Hematoma size | Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours) | 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. |
| Ecchymosis occurrence | Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours) | Presence of ecchymosis at the radial access site assessed hourly by visual inspection (yes/no). |
| Bleeding occurrence | Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours) | Presence of bleeding at the radial access site assessed hourly (yes/no). |
| Bleeding amount | At ICU admission (baseline) and at TR band removal (up to 6 hours) | Volume of bleeding quantified in milliliters when present. |
| Patient comfort (EPCS) | At ICU admission (baseline) and at TR band removal (up to 6 hours) | 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. |
| Oedema occurrence at the radial access site | Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours) | Presence of oedema at the puncture site assessed hourly by visual inspection and clinical examination (yes/no). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TR Band dwell time | From ICU admission after the procedure until TR band removal (up to 6 hours) | Duration of TR Band placement, calculated as the interval between ICU admission and TR Band removal, measured in hours. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORŞeymanur Gökce ÇIŞAN
Adnan Menderes Bulvarı (Vatan Cad.) P.K. 34093 Fatih / İstanbul
PRINCIPAL_INVESTIGATORGülsün Özdemir Aydın, PhD
Istanbul University Faculty of Nursing
STUDY_CHAIRTürkinaz Aştı, Professor
Esentepe Mahallesi, Silahtarağa Caddesi No:189 (İğdaş Genel Müdürlüğü Karşısı) Eyüpsultan / İSTANBUL
Outcome results
None listed