EffectofCold: The Effect of Cold Spray Applied Before Local Anaesthesia

Sponsor

Ozkan Sir (Other)

Overall Status

Recruiting

CT.gov ID

NCT06035237

Collaborator

(none)

Enrollment

Location

Arms

23.1

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Anxiety Coronary Artery Disease	Other: Cold Spray	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 3, 2023

Actual Primary Completion Date :

Mar 5, 2023

Anticipated Study Completion Date :

Dec 6, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Pain levels recorded with the Visual Analog Scale [1 minute]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Van yüzüncü yıl university	Van		Turkey	65080

Sponsors and Collaborators

Ozkan Sir

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ozkan Sir, PhD student, Yuzuncu Yıl University

ClinicalTrials.gov Identifier:

NCT06035237

Other Study ID Numbers:

Özkan

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 15, 2023

Last Verified:

Sep 1, 2023

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

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

Keywords provided by Ozkan Sir, PhD student, Yuzuncu Yıl University

Pain, anxiety, cold spray, angiography

Additional relevant MeSH terms:

Coronary Artery Disease

Anxiety Disorders

Study Results

No Results Posted as of Sep 15, 2023