Radial ArteryNCT05511675
The Effect of Cold Application on the Hemostasis, Extremity Pain And Terumo Band Usage After Transradial Angiography
A study testing cold application in people with Radial Artery and Pain, run by Duzce University.
Trial summary
According to the World Health Organization data, approximately 17.9 million people die every year due to heart disease. 85% of these deaths are due to heart attack and blocked blood vessels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radial Artery, Pain, Local Application / Packing Too Cold
- What is being tested?
- cold application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2024to 15 Nov 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First time receivers of transradial angiography
- Neurovascular extremities must be healthy,
- Must be conscious,
- For the angiography 5 french arterial sheath hydrophylic catheter must be used
- Patients for the study must be voluntary
Who cannot join
- Unconscious,
- Patients who have unstable Diabetes mellitus,
- Patients who have chronic pain,
- Patients who have carpel tunnel syndrome,
- Patients who have rheumatoid - arthritis,
- Patients who have upper extremity physical disability
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- Patients who have any cancer,
- Patients who have bleeding disorders, for example: haemophilia
- Patients who decline to participate in the study.
- Patient criteria for study rejection
- Patients who have current chest pain and whose specialist doctor considers their condition too serious for them to participate.
Trial locations and contacts
No sites are listed yet.
About this study
According to the World Health Organization data, approximately 17.9 million people die every year due to heart disease. 85% of these deaths are due to heart attack and blocked blood vessels. The Turkish Statistical Institute reports that circulatory system diseases took the first place among the causes of death with 38.4%, while ischemic heart diseases constituted 39.7% of these deaths in 2018. Transradial angiography is used for the purpose of scanning and treatment of coronary arteries both in Turkey and in other countries of the world.
Aim: After transradial angiography, Terumo (TR) band is used as a common device which is provides pneumatical hemostasis. This study aims to reduce usage time of the TR band, a decrease of hematoma formation and a reduction in the level of extremities pain experienced as a result of transradial angiography, thanks to using the TR band together with cold application.
Read the detailed description
According to the World Health Organization data, approximately 17.9 million people die every year due to heart disease. 85% of these deaths are due to heart attack and blocked blood vessels. The Turkish Statistical Institute reports that circulatory system diseases took the first place among the causes of death with 38.4%, while ischemic heart diseases constituted 39.7% of these deaths in 2018. Transradial angiography is used for the purpose of scanning and treatment of coronary arteries both in Turkey and in other countries of the world.
Aim: After transradial angiography, Terumo (TR) band is used as a common device which is provides pneumatical hemostasis. This study aims to reduce usage time of the TR band, a decrease of hematoma formation and a reduction in the level of extremities pain experienced as a result of transradial angiography, thanks to using the TR band together with cold application.
Method: This study is planned to be carried out among the patients who apply for transradial angiography between 15.09.2022 and 15.01.2023 at Düzce University Health Application and Research Center. This study will consist of a control and two experimental groups. This study is planned to be done as a single blind randomised control trial and will use equal samples block randomisation design. The study is planned to comprise of 120 patients, 40 patients in each group, taking into account possible losses. Samples number is to be calculated via G-power 3.1.9.7 programme.
Patients who are in the control group will receive standard clinical care and pain level and hematoma condition will be recorded. In addition usage time of the TR band will be in accordance with the manufacturer's guidelines and will be recorded with the help of a chronometer.
Study group I and group II patients will have cold application twice for a twenty minute period each time. For study group I extremity pain and hematoma will be followed and the TR band will be removed after one and a half hours.
Whereas, for study group II extremity pain and hematoma will be followed but the TR band will be removed in accordance with manufacturer's guidelines as in the control group.
Data accumulation methods: socio-demographic patient information form, the McGill pain measurement questionnaire and research tracking form will be used.
For pain the McGill pain measurement, for hematoma single use paper tape, for the TR band usage time will be recorded via a chronometer.
For study group I and II patients, cold ball (ISO BALL) application intervention will be carried out.
- Being tested
- cold application
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold applicationDevice
ISO-BALL
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients who are in the control group will receive standard clinical care and pain level and hematoma condition will be recorded. In addition usage time of the TR band will be in accordance with the manufacturer's guidelines and will be recorded with the help of a chronometer. |
| experimental group I | Experimental | Study group I patients will have cold application twice for a twenty minute period each time. For study group I extremity pain and hematoma will be followed and the TR band will be removed after one and a half hours. Receives: Device: cold application |
| experimental group II | Experimental | Study group II patients will have cold application twice for a twenty minute period each time and extremity pain and hematoma will be followed but the TR band will be removed in accordance with manufacturer's guidelines as in the control group. Receives: Device: cold application |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain levels
pain measurement will be made by McGill Pain Survey Short Form. The survey includes visual analog score. The intensity of pain will measure the area in which the individual mark between 0 (no pain) and 10 (worst pain i felt in my life). The pain level will be asked Three times in approximately three hours for all groups patients after transradial angiography
Measured: one day
hematoma
hematoma formation condition will be recorded by single use paper tape measurement for all groups patients. It will be measured three times in approximately three hours after transradial angiography.
Measured: one day
Secondary outcomes (1)
Time of Terumo band usage
time of Terumo band usage will be recorded by chronometer after transradial angiography for all groups patients. Because we want to measure terumo band usage time differences among groups.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start15 Apr 2024 (estimated)
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial ArteryStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- atiye erbas, PhD, Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511675
- Sponsor's protocol ID
- DuzceU-ismail-01
- Status last verified
- Mar 2024
- First submitted
- 18 Aug 2022
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Application on the Hemostasis, Extremity Pain And Terumo Band Usage After Transradial Angiography
- ClinicalTrials.gov ID
- NCT05511675
- Acronym / sponsor ID
- DuzceU-ismail-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 23 Aug 2022 (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.
According to the World Health Organization data, approximately 17.9 million people die every year due to heart disease. 85% of these deaths are due to heart attack and blocked blood vessels. The Turkish Statistical Institute reports that circulatory system diseases took the first place among the causes of death with 38.4%, while ischemic heart diseases constituted 39.7% of these deaths in 2018. Transradial angiography is used for the purpose of scanning and treatment of coronary arteries both in Turkey and in other countries of the world.
Aim: After transradial angiography, Terumo (TR) band is used as a common device which is provides pneumatical hemostasis. This study aims to reduce usage time of the TR band, a decrease of hematoma formation and a reduction in the level of extremities pain experienced as a result of transradial angiography, thanks to using the TR band together with cold application.
Detailed description
According to the World Health Organization data, approximately 17.9 million people die every year due to heart disease. 85% of these deaths are due to heart attack and blocked blood vessels. The Turkish Statistical Institute reports that circulatory system diseases took the first place among the causes of death with 38.4%, while ischemic heart diseases constituted 39.7% of these deaths in 2018. Transradial angiography is used for the purpose of scanning and treatment of coronary arteries both in Turkey and in other countries of the world.
Aim: After transradial angiography, Terumo (TR) band is used as a common device which is provides pneumatical hemostasis. This study aims to reduce usage time of the TR band, a decrease of hematoma formation and a reduction in the level of extremities pain experienced as a result of transradial angiography, thanks to using the TR band together with cold application.
Method: This study is planned to be carried out among the patients who apply for transradial angiography between 15.09.2022 and 15.01.2023 at Düzce University Health Application and Research Center. This study will consist of a control and two experimental groups. This study is planned to be done as a single blind randomised control trial and will use equal samples block randomisation design. The study is planned to comprise of 120 patients, 40 patients in each group, taking into account possible losses. Samples number is to be calculated via G-power 3.1.9.7 programme.
Patients who are in the control group will receive standard clinical care and pain level and hematoma condition will be recorded. In addition usage time of the TR band will be in accordance with the manufacturer's guidelines and will be recorded with the help of a chronometer.
Study group I and group II patients will have cold application twice for a twenty minute period each time. For study group I extremity pain and hematoma will be followed and the TR band will be removed after one and a half hours.
Whereas, for study group II extremity pain and hematoma will be followed but the TR band will be removed in accordance with manufacturer's guidelines as in the control group.
Data accumulation methods: socio-demographic patient information form, the McGill pain measurement questionnaire and research tracking form will be used.
For pain the McGill pain measurement, for hematoma single use paper tape, for the TR band usage time will be recorded via a chronometer.
For study group I and II patients, cold ball (ISO BALL) application intervention will be carried out.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients who are in the control group will receive standard clinical care and pain level and hematoma condition will be recorded. In addition usage time of the TR band will be in accordance with the manufacturer's guidelines and will be recorded with the help of a chronometer. |
| experimental group I | Experimental | Device: cold applicationStudy group I patients will have cold application twice for a twenty minute period each time. For study group I extremity pain and hematoma will be followed and the TR band will be removed after one and a half hours. |
| experimental group II | Experimental | Device: cold applicationStudy group II patients will have cold application twice for a twenty minute period each time and extremity pain and hematoma will be followed but the TR band will be removed in accordance with manufacturer's guidelines as in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First time receivers of transradial angiography
- Neurovascular extremities must be healthy,
- Must be conscious,
- For the angiography 5 french arterial sheath hydrophylic catheter must be used
- Patients for the study must be voluntary
Key exclusion criteria (11 listed)
- Unconscious,
- Patients who have unstable Diabetes mellitus,
- Patients who have chronic pain,
- Patients who have carpel tunnel syndrome,
- Patients who have rheumatoid - arthritis,
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 |
|---|---|---|
| cold applicationISO-BALL | Device | experimental group I, experimental group II |
Primary outcome
pain levels
Time frame: one day
pain measurement will be made by McGill Pain Survey Short Form. The survey includes visual analog score. The intensity of pain will measure the area in which the individual mark between 0 (no pain) and 10 (worst pain i felt in my life). The pain level will be asked Three times in approximately three hours for all groups patients after transradial angiography
hematoma
Time frame: one day
hematoma formation condition will be recorded by single use paper tape measurement for all groups patients. It will be measured three times in approximately three hours after transradial angiography.
1 secondary outcome
Time of Terumo band usage
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
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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.
atiye erbas, PhD principal investigator
Duzce University
Questions about this trial
What is this clinical trial studying?
A study testing cold application in people with Radial Artery and Pain, run by Duzce University.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ismail asatir, assistant (5325613681, ismailasatir@duzce.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain levels (time frame: one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2024.