The Effect of Cold Application on the Hemostasis, Extremity Pain And Terumo Band Usage After Transradial Angiography

NCT ID: NCT05511675

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2024-11-15

Brief 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. 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.

Conditions

Radial Artery; Pain; Local Application / Packing Too Cold; Hemostasis; Angiography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

experimental group I

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.

Group Type: EXPERIMENTAL

cold application

Intervention Type: DEVICE

ISO-BALL

experimental group II

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.

Group Type: EXPERIMENTAL

cold application

Intervention Type: DEVICE

ISO-BALL

Interventions

cold application

ISO-BALL

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duzce University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

atiye erbas, PhD

Role: PRINCIPAL_INVESTIGATOR

Duzce University

Central Contacts

ismail asatir, assistant

Role: CONTACT

ismailasatir@duzce.edu.tr

5325613681

atiye erbas, PhD

Role: CONTACT

atiyeerbas@duzce.edu.tr

5057285837

Other Identifiers

DuzceU-ismail-01

Identifier Type: -

Identifier Source: org_study_id