Determination of the Effect of Cold Needle on Invasive Pain Cannulation

NCT06418009 | Active Not Recruiting

• 1 other identifier: 2024/50
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Not cold needle application

NO INTERVENTION

Fistül girişimi için kullanılan iğne kendi torbasında durdurulur ve hastalığın takılacağı zaman Resmi tarafından deponun içinden çıkarılarak kullanılacaktır

Cold needle application

EXPERIMENTAL

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.

Procedure: Cold needle application

Interventions

Cold needle application PROCEDURE

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.

Cold needle application

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Demiroglu Bilim University: lead

Study Sites (1)

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

Location

Related 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.

  PMID: 36068183 BACKGROUND

• 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.

  PMID: 37645007 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nurten Ozen, Assoc. Prof.

  Istanbul Demiroglu Bilim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pain assessment will be made by a nurse independent of the study
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: April 20, 2024
• Primary Completion: May 5, 2024
• Study Completion: May 20, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)