The Effect of Cold Spray Applied Before Local Anaesthesia (EffectofCold)
The Effect of Cold Spray Applied Before Local Anaesthesia on Pain and Anxiety in Coronary Angiography Procedure: a Randomised Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Van, Turkey, 65080
- Van Yuzuncu Yıl University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain levels recorded with the Visual Analog Scale
Time Frame: 1 minute
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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.
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1 minute
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Özkan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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