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The Effect of Cold Spray Applied Before Local Anaesthesia (EffectofCold)

Primary Purpose

Pain, Anxiety, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cold Spray
Sponsored by
Ozkan Sir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Pain, anxiety, cold spray, angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Van yüzüncü yıl universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2023
Last Updated
September 13, 2023
Sponsor
Ozkan Sir
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1. Study Identification

Unique Protocol Identification Number
NCT06035237
Brief Title
The Effect of Cold Spray Applied Before Local Anaesthesia
Acronym
EffectofCold
Official Title
The Effect of Cold Spray Applied Before Local Anaesthesia on Pain and Anxiety in Coronary Angiography Procedure: A Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
March 5, 2023 (Actual)
Study Completion Date
December 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ozkan Sir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Coronary Artery Disease
Keywords
Pain, anxiety, cold spray, angiography

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cold Spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain levels recorded with the Visual Analog Scale
Description
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.
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Özkan SİR, PhD
Phone
+905459072231
Email
ozkansir@yyu.edu.tr
Facility Information:
Facility Name
Van yüzüncü yıl university
City
Van
ZIP/Postal Code
65080
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Özkan SİR
Email
ozkansir@yyu.edu.tr

12. IPD Sharing Statement

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The Effect of Cold Spray Applied Before Local Anaesthesia

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