Clinical trial NCT06418009: Determination of the Effect of Cold Needle on Invasive Pain Cannulation
Official title: Determination of the Effect of Cold Needle Application on Invasive Pain Associated With Fistula Cannulation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hemodialysis Complication
Pain
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Invasive pain
timeFrame: Up to two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Demiroglu Bilim University
Study officials:
affiliation: Istanbul Demiroglu Bilim University
name: Nurten Ozen, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.