The Effect of Cold Spray Applied Before Local Anaesthesia

NCT ID: NCT06035237

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2023-12-06

Brief Summary

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Coronary angiography is a reliable and valid method used in the diagnosis of Coronary Artery Disease (CAD). Coronary angiography is defined as the process of obtaining cineangiographic images by administering radio-opaque material to the coronary vessels via arterial route. Coronary angiography is frequently performed from brachial, radial and femoral arteries. The aim of coronary angiography is to determine the presence, localisation and extent of cardiovascular lesions.

Invasive interventions cause anxiety and pain in the patient, increase the level of anxiety and cause a number of negative effects such as increased use of sedative drugs, development of post-procedure complications, prolongation of the recovery process and hospitalisation time. It is stated that there is a positive relationship between reducing the anxiety of the patients and meeting the needs of the patients.

Detailed Description

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Conditions

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Pain Anxiety Coronary Artery Disease

Keywords

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Pain, anxiety, cold spray, angiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Experimental Group

Patients in the experimental group were informed that cold spray would be applied to their arm in a supine position to reduce procedure-related pain. For femoral artery angiography, the central part of the inguinal access area was targeted, and for radial angiography, 2 cm above the styloid process of the radial bone was targeted, and cold spray (Chloroethyl spray) was applied for approximately 3 seconds from a height of 10 cm.

Group Type EXPERIMENTAL

Cold Spray

Intervention Type OTHER

Cold Spray: Cold sprays, composed of liquefied gases under high pressure, rapidly evaporate from the applied area, causing a sudden drop in skin temperature. This condition leads to the temporary desensitization of pain receptors or the activation of ion channels, resulting in the brief alleviation of pain sensation. Various medical, non-medical, and surgical methods are employed to manage pain. Cold sprays are among non-medical methods, including massage, cold application, and distraction techniques. Therefore, cold sprays cannot be prescribed like medication. They are used for local anesthesia in cases of acute trauma, injections, blood collection, vein puncture, and similar situations.

Control Group

Pain levels recorded with the VAS were evaluated for patients after the procedure using the state anxiety scale. Pain levels for control group patients were also assessed and recorded within the sheath after intravenous solutions were given. Anxiety levels were recorded after the procedure was completed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cold Spray

Cold Spray: Cold sprays, composed of liquefied gases under high pressure, rapidly evaporate from the applied area, causing a sudden drop in skin temperature. This condition leads to the temporary desensitization of pain receptors or the activation of ion channels, resulting in the brief alleviation of pain sensation. Various medical, non-medical, and surgical methods are employed to manage pain. Cold sprays are among non-medical methods, including massage, cold application, and distraction techniques. Therefore, cold sprays cannot be prescribed like medication. They are used for local anesthesia in cases of acute trauma, injections, blood collection, vein puncture, and similar situations.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being between the ages of 18 and above.
* Not having used any anesthetic substance before the procedure.
* Not having undergone angiography before.
* Having no communication problems.

Exclusion Criteria

* Having previously undergone angiography.
* Having taken analgesics before angiography.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ozkan Sir

OTHER

Sponsor Role lead

Responsible Party

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Ozkan Sir

PhD student

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Van yüzüncü yıl university

Van, Van, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Özkan

Identifier Type: -

Identifier Source: org_study_id