Determination of the Effect of Cold Needle on Invasive Pain Cannulation

Pain Clinical Trial

Official title:

Determination of the Effect of Cold Needle Application on Invasive Pain Associated With Fistula Cannulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06418009
• Other study ID #: 2024/50
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: May 20, 2024

Study information

• Verified date: May 2024
• Source: Istanbul Demiroglu Bilim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In studies evaluating the methods used to reduce invasive pain associated with cannulation, it is seen that pharmacological and non-pharmacological methods are used. Pharmacological treatment is considered risky as it may cause drug addiction in the patient and may cause side effects and complications. On the other hand, the use of non-pharmacological methods is preferred because they are cheaper and cause fewer side effects and complications.

Description:

Cold application, one of the non-pharmacological methods used, is effective in relieving pain by slowing down or blocking the conduction of peripheral nerves. Apart from this effect, it stimulates touch receptors by activating the Door-Control mechanism; It increases the release of endogenous opioids and stops pain by ensuring the nerve impulses caused by cold are transmitted to Delta fibers. Although studies conducted on hemodialysis patients have shown that cold application is effective in reducing pain; Due to the small number of sample groups and deficiencies in the methodology, it was suggested that further studies be conducted. In these studies, cold application; It was applied to the area one cm above the fistula or between the thumb and index finger of the opposite arm, using an ice pack and an ice-filled glove for 2-10 minutes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: May 20, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients aged 18 years and older

• had been treated with HD for at least 3 months, thrice a week, and for 4 hours per session

• did not have a psychiatric disorder that would prevent communication

• volunteered to participate in the study

Exclusion Criteria:

• Patients who were known to present difficulties when entering the fistula (requiring multiple cannulations)

• had a history of hematoma or stenosis in the AVF

• had an infection at the fistula site

• took painkillers within 3 hours of treatment

• did not want to participate in the study

Related Conditions & MeSH terms

• Hemodialysis Complication
• Pain

Intervention

Procedure:
• Cold needle application
Before use, the needle will be removed from the refrigerator and kept on the nurse's table. When the temperature of the needle reaches 0-2 °C, the patient will be cannulated.

Locations

Country	Name	City	State
Turkey	Demiroglu Bilim University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Demiroglu Bilim University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Ozen N, Tosun B, Sayilan AA, Eyileten T, Ozen V, Ecder T, Tosun N. Effect of the arterial needle bevel position on puncture pain and postremoval bleeding time in hemodialysis patients: A self-controlled, single-blind study. Hemodial Int. 2022 Oct;26(4):503-508. doi: 10.1111/hdi.13044. Epub 2022 Sep 6. — View Citation

Sadeghpour Marvi H, Baloochi Beydokhti T, Sajjadi M, Khaleghimanesh B. Comparing Effects of Rhythmic Breathing and Lidocaine Spray on Pain Intensity During Needle Insertion Into Arteriovenous Fistula in Hemodialysis Patients: A Randomized Controlled Trial. Anesth Pain Med. 2023 Apr 17;13(2):e126384. doi: 10.5812/aapm-126384. eCollection 2023 Apr. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive pain	It will be assessed three times at the end of the dialysis session with Visual Analogue. Pain intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. Pain increases as the score increases. The high point describes bad outcome	Up to two weeks