Coronary Artery DiseaseNCT07797179
Effect of Cold Application on Pain, Ecchymosis, and Comfort After Transradial Coronary Angiography
A study testing Standard Post-Procedural TR Band Care and Cold Application in people with Coronary Artery Disease, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Standard Post-Procedural TR Band Care and Cold Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University Hospital - Coronary Intensive Care Unit
Istanbul, 34116
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Standard Post-Procedural TR Band Care, Cold Application
- Keywords
- Transradial angiography, TR band, cold application, pain management, comfort level
- Medical subject headings
- Coronary Artery Disease, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Post-Procedural TR Band CareOther
Also called Routine 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.
Cold ApplicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Post-Procedural TR Band Care; Other: Cold Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours)
Secondary outcomes (1)
TR Band dwell time
Duration of TR Band placement, calculated as the interval between ICU admission and TR Band removal, measured in hours.
Measured: From ICU admission after the procedure until TR band removal (up to 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start31 Jan 2023
- Primary completion30 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Türkinaz Aştı, Bezmialem Vakif University
- Investigators
- Şeymanur Gökce ÇIŞAN, Study director, Adnan Menderes Bulvarı (Vatan Cad.) P.K. 34093 Fatih / İstanbulGülsün Özdemir Aydın, PhD, Principal investigator, Istanbul University Faculty of NursingTürkinaz Aştı, Professor, Study chair, Esentepe Mahallesi, Silahtarağa Caddesi No:189 (İğdaş Genel Müdürlüğü Karşısı) Eyüpsultan / İSTANBUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797179
- Sponsor's protocol ID
- 2023/200
- Status last verified
- Oct 2025
- First submitted
- 18 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported results will be made available upon reasonable request to the corresponding author, following approval of a methodologically sound proposal, for the purpose of achieving the aims outlined in the approved proposal.
Publications
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.
PubMed 36932774Turen 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.
PubMed 35307131Kheirabad 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.
PubMed 37356871Elsaman 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.
PubMed 36414367Mert 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.
PubMed 30367542Salleras-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.
PubMed 37633742Sugiharto 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.
PubMed 39822338Çürük, 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cold Application on Pain, Ecchymosis, and Comfort After Transradial Coronary Angiography
- ClinicalTrials.gov ID
- NCT07797179
- Acronym / sponsor ID
- 2023/200
- Conditions
- Coronary Artery Disease
- Keywords
- Transradial angiography, TR band, cold application, pain management, comfort level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Standard Post-Procedural TR Band CareParticipants 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. |
| Intervention Group (Cold Application) | Experimental | Other: Standard Post-Procedural TR Band Care, Other: Cold ApplicationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Post-Procedural TR Band CareAlso: Routine Post-Procedural TR Band CareProtocolized 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. | Other | Control Group, Intervention Group (Cold Application) |
| Cold ApplicationGel 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. | Other | Intervention Group (Cold Application) |
Primary outcome
Pain intensity at the radial access site (NRS, 0-10)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At ICU admission (baseline) and at TR band removal (up to 6 hours)
Volume of bleeding quantified in milliliters when present.
Patient comfort (EPCS)
Time frame: 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
Time frame: 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).
1 secondary outcome
TR Band dwell time
Time frame: From ICU admission after the procedure until TR band removal (up to 6 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Results publication: PubMed 36932774Zhang 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.
- Results publication: PubMed 35307131Turen 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.
- Results publication: PubMed 37356871Kheirabad 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.
- Results publication: PubMed 36414367Elsaman 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.
- Results publication: PubMed 30367542Mert 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.
- Results publication: PubMed 37633742Salleras-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.
- Results publication: PubMed 39822338Sugiharto 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.
- Results publicationÇürük, 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
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported results will be made available upon reasonable request to the corresponding author, following approval of a methodologically sound proposal, for the purpose of achieving the aims outlined in the approved proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şeymanur Gökce ÇIŞAN study director
Adnan Menderes Bulvarı (Vatan Cad.) P.K. 34093 Fatih / İstanbul
Gülsün Özdemir Aydın, PhD principal investigator
Istanbul University Faculty of Nursing
Türkinaz Aştı, Professor study chair
Esentepe Mahallesi, Silahtarağa Caddesi No:189 (İğdaş Genel Müdürlüğü Karşısı) Eyüpsultan / İSTANBUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Post-Procedural TR Band Care and Cold Application in people with Coronary Artery Disease, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity at the radial access site (NRS, 0-10) (time frame: Hourly, from ICU admission after the procedure until TR band removal (up to 6 hours)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07797179, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.