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

NCT05511675 | Not Yet Recruiting

• 1 other identifier: DuzceU-ismail-01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  one day

Secondary Outcomes (1)

• Time of Terumo band usage

  one day

Study Arms (3)

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.

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.

Device: cold application

Interventions

cold application DEVICE

ISO-BALL

experimental group I; experimental group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duzce University: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• atiye erbas, PhD

  Duzce University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ismail asatir, assistant

CONTACT

5325613681; ismailasatir@duzce.edu.tr

atiye erbas, PhD

CONTACT

5057285837; atiyeerbas@duzce.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 23, 2022
• Study Start: April 15, 2024
• Primary Completion: April 15, 2024
• Study Completion: November 15, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share