The Effect of Cold Spray Applied Before Local Anaesthesia

Pain Clinical Trial

— EffectofCold  

Official title:

The Effect of Cold Spray Applied Before Local Anaesthesia on Pain and Anxiety in Coronary Angiography Procedure: A Randomised Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035237
• Other study ID #: Özkan
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: December 6, 2024

Study information

• Verified date: September 2023
• Source: Yuzuncu Yil University
• Contact: Özkan SIR, PhD
• Phone: +905459072231
• Email: ozkansir[@]yyu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 6, 2024
• Est. primary completion date: March 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Coronary Artery Disease
• Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Van yüzüncü yil university	Van

Sponsors (1)

Lead Sponsor	Collaborator
Ozkan Sir

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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