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

Sponsor

Duzce University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05511675

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radial Artery Pain Local Application / Packing Too Cold Hemostasis Angiography	Device: cold application	N/A

Detailed Description

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

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Jan 15, 2023

Anticipated Study Completion Date :

Jan 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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.	Device: cold application ISO-BALL
Experimental: 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.	Device: cold application ISO-BALL

Arm

Intervention/Treatment

No Intervention: control group

Experimental: 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.

Device: cold application

ISO-BALL

Experimental: 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.

Device: cold application

ISO-BALL

Outcome Measures

Primary Outcome Measures

pain levels [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 [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.

Secondary Outcome Measures

Time of Terumo band usage [one day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Duzce University

Investigators

Principal Investigator: atiye erbas, PhD, Duzce University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duzce University

ClinicalTrials.gov Identifier:

NCT05511675

Other Study ID Numbers:

DuzceU-ismail-01

First Posted:

Aug 23, 2022

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 23, 2022