The Effect of Cold Spray Applied Before Local Anaesthesia

NCT06035237 | Completed

• 1 other identifier: Özkan
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Anxiety; Coronary Artery Disease

Keywords

Pain, anxiety, cold spray, angiography

Outcome Measures

Primary Outcomes (1)

• Pain levels recorded with the Visual Analog Scale

  VAS was used to evaluate the pain of the patients. The scale consists of emotion adjectives in which each emotion experienced by the person at that moment is marked with a vertical line on a plane. A value of zero is considered as not experiencing pain at all, and a value of ten is considered as experiencing pain completely.

  1 minute

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Cold Spray

Control Group

NO INTERVENTION

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.

Interventions

Cold Spray 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.

Experimental Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Having previously undergone angiography.
• Having taken analgesics before angiography.

Sponsors & Collaborators

• Ozkan Sir: lead

Study Sites (1)

Van yüzüncü yıl university

Van, Van, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: January 3, 2023
• Primary Completion: March 5, 2023
• Study Completion: December 6, 2023
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

TU (1)