Effect of Cold Application on Pain, Ecchymosis, and Comfort After Transradial Coronary Angiography

NCT07797179 | Completed

• 1 other identifier: 2023/200
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Transradial angiography, TR band, cold application, pain management, comfort level

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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).

  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).

  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.

  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.

  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).

  Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours)

Secondary Outcomes (1)

• TR Band dwell time

  From ICU admission after the procedure until TR band removal (up to 6 hours)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants received routine post-procedural TR Band care, including standard hourly balloon deflation, monitoring for bleeding and vascular complications, and pain assessment. No cold application was performed.

Other: Standard Post-Procedural TR Band Care

Intervention Group (Cold Application)

EXPERIMENTAL

Participants received standard post-procedural TR Band care plus intermittent cold application: pre-frozen gel packs applied to the wrist for 15 minutes every hour until TR Band removal.

Other: Standard Post-Procedural TR Band Care; Other: Cold Application

Interventions

Standard Post-Procedural TR Band Care OTHER

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.

Also known as: Routine Post-Procedural TR Band Care

Control Group; Intervention Group (Cold Application)

Cold Application OTHER

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.

Intervention Group (Cold Application)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bezmialem Vakif University: lead
• Istanbul University: collaborator

Study Sites (1)

Bezmialem Vakif University Hospital - Coronary Intensive Care Unit

Istanbul, 34116, Turkey (Türkiye)

Location

Related Publications (8)

• Zhang J, Sun W, Wang T, Li J, Yu M. Effect of preoperative functional exercise on cephalic vein diameter, anastomotic blood flow, and postoperative complications in patients with arteriovenous internal fistuloplasty. J Pak Med Assoc. 2023 Mar;73(3):653-655. doi: 10.47391/JPMA.6224.

  PMID: 36932774 RESULT

• Turen S, Yilmaz RA, Yesiltepe N, Bektas I. Effect of the head of bed elevation on back pain after elective coronary angiography: A randomized controlled trial. Appl Nurs Res. 2022 Apr;64:151571. doi: 10.1016/j.apnr.2022.151571. Epub 2022 Mar 1.

  PMID: 35307131 RESULT

• Kheirabad MK, Mohebbi Z, Kalyani MN, Kojuri J. Vascular outcomes of early deflation of radial artery band following coronary angiography: A controlled clinical trial. J Vasc Nurs. 2023 Jun;41(2):56-61. doi: 10.1016/j.jvn.2023.04.001. Epub 2023 Apr 27.

  PMID: 37356871 RESULT

• Elsaman SEA. Association of position change and back massage and early ambulation with post-transfemoral coronary angiography complications. J Vasc Nurs. 2022 Sep;40(3):128-133. doi: 10.1016/j.jvn.2022.08.003. Epub 2022 Sep 11.

  PMID: 36414367 RESULT

• Mert Boga S, Oztekin SD. The effect of position change on vital signs, back pain and vascular complications following percutaneous coronary intervention. J Clin Nurs. 2019 Apr;28(7-8):1135-1147. doi: 10.1111/jocn.14704. Epub 2018 Nov 22.

  PMID: 30367542 RESULT

• Salleras-Duran L, Fuentes-Pumarola C, Fontova-Almato A, Roqueta-Vall-Llosera M, Camara-Liebana D, Ballester-Ferrando D. Pain and Satisfaction Perceptions of Ultrasound-Guided Versus Conventional Peripheral Intravenous Catheterization: A Randomized Controlled Trial. Pain Manag Nurs. 2024 Feb;25(1):e37-e44. doi: 10.1016/j.pmn.2023.07.010. Epub 2023 Aug 24.

  PMID: 37633742 RESULT

• Sugiharto F, Yusanti I, Sari WP, Yuliandani E, Kosasih CE, Trisyani Y, Priambodo AP, Nuraeni A, Anna A, Emaliyawati E, Mirwanti R. A Systematic Review of the Potential of Cold Compresses Therapy: Strategy for Preventing Hematoma and Alleviating Pain in Post Cardiac Catheterization Patients. J Pain Res. 2025 Jan 11;18:161-175. doi: 10.2147/JPR.S478280. eCollection 2025.

  PMID: 39822338 RESULT

• Çürük, G. N. (2017). The Effect of Ice-Bag Applied to Femoral Region of Individuals with Percutaneous Coronary Intervention on Local Vascular Complications and Low Back-Pain. IOSR Journal of Nursing and Health Science, 06(01), 136-144. https://doi.org/10.9790/1959-060105136144

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Coronary Artery Disease; Agnosia

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Şeymanur Gökce ÇIŞAN

  Adnan Menderes Bulvarı (Vatan Cad.) P.K. 34093 Fatih / İstanbul

  STUDY DIRECTOR

• Gülsün Özdemir Aydın, PhD

  Istanbul University Faculty of Nursing

  PRINCIPAL INVESTIGATOR

• Türkinaz Aştı, Professor

  Esentepe Mahallesi, Silahtarağa Caddesi No:189 (İğdaş Genel Müdürlüğü Karşısı) Eyüpsultan / İSTANBUL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. The study was open-label.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Head of Nursind Department

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: September 1, 2026
• Study Start: January 31, 2023
• Primary Completion: January 30, 2025
• Study Completion: February 28, 2025
• Last Updated: September 1, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months following publication of the study results and ending 5 years following publication.
• Access Criteria: Deidentified individual participant data and supporting information will be made available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the study investigators for scientific merit and compliance with ethical and institutional requirements. Approved researchers will be provided access to data relevant to the approved proposal upon reasonable request to the corresponding author. Data will be used only for the purposes specified in the approved proposal and will not contain information that could directly identify individual participants.

Locations

TU (1)