Determination of the Effect of Cold Needle on Invasive Pain Cannulation

NCT ID: NCT06418009

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-20

Study Completion Date

2024-05-20

Brief Summary

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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

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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.

Conditions

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Hemodialysis Complication Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Pain assessment will be made by a nurse independent of the study

Study Groups

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Not cold needle application

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Cold needle application

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Demiroglu Bilim University

OTHER

Sponsor Role lead

Responsible Party

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Nurten Ozen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nurten Ozen, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Istanbul Demiroglu Bilim University

Locations

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Demiroglu Bilim University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 36068183 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37645007 (View on PubMed)

Other Identifiers

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2024/50

Identifier Type: -

Identifier Source: org_study_id

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