## Protocol Section
### Identification Module
**NCT ID:** NCT06418009

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2024/50
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Demiroglu Bilim University
### Status Module
#### Completion Date
**Date:** 2024-05-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-05-05

**Type:** ACTUAL

#### Start Date
**Date:** 2024-04-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istanbul Demiroglu Bilim University

#### Responsible Party

**Investigator Affiliation:** Istanbul Demiroglu Bilim University

**Investigator Full Name:** Nurten Ozen

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hemodialysis Complication

- Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Pain assessment will be made by a nurse independent of the study

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 35

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Label:** Not cold needle application

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** 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 Names:**

- Procedure: Cold needle application

**Label:** Cold needle application

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cold needle application

**Description:** 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.

**Name:** Cold needle application

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Invasive pain

**Time Frame:** Up to two weeks

### Eligibility Module

**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

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Demiroglu Bilim University

**Zip:** 34384

#### Overall Officials

**Official 1:**

**Affiliation:** Istanbul Demiroglu Bilim University

**Name:** Nurten Ozen, Assoc. Prof.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 36068183

**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.

**PMID:** 37645007

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M8532

- Name: Fistula

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
