Arteriovenous Fistula Pain and Cold Application

March 6, 2025 updated by: Mehtap KAVURMACI, Ataturk University

The Effect of Cold Application Using Two Different Methods on Arteriovenous Fistula Pain

TThis study was designed as a single-group comparative prospective intervention study. The aim of the study was to assess the effectiveness of different pain management interventions during AVF cannulation. The effects of pain management methods such as cooling spray, aloe vera gel, and the standard procedure on pain levels, and which intervention was more effective in reducing pain compared to the standard procedure, were investigated.

The study included patients over 18 and under 65 years old, undergoing hemodialysis, having an AVF, literate, without an aloe vera allergy, and without communication barriers or psychiatric disorders.

The main research questions were defined as follows: Did different pain management methods (cooling spray, aloe vera gel, and standard procedure) affect pain levels during AVF cannulation? Which intervention was more effective in reducing pain levels? The primary hypotheses were defined as The application of cooling spray and aloe vera gel would reduce pain levels more than the standard procedure.

The researchers compared pain levels after each intervention to determine which one was more effective. Three different interventions (cooling spray, aloe vera gel, and standard procedure) were applied to participants in sequence, and pain levels were assessed after each intervention using the Visual Analog Scale (VAS). Additionally, feedback from participants regarding each intervention was collected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey, 25000
        • Atatürk Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Over 18 and under 65 years old
  • Literate
  • Have an arteriovenous fistula (AVF)
  • Undergoing hemodialysis (HD) treatment at least twice a week
  • No allergy to aloe vera
  • No communication barriers and/or psychiatric disorders

Exclusion Criteria:

  • Diagnosed with malignancy
  • Having any sensory problems that prevent the assessment of perception and pain
  • Using any analgesic preparations
  • Having a vascular access other than AVF
  • Patients in whom AVF cannulation is not successful in a single attempt

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single Group Assignment
Three different interventions (cooling spray, aloe vera gel, and standard procedure) were applied to participants in sequence
Other: Cooling Spray

A cooling spray containing propan-butane-pentane was applied 25 cm from the cannulation site until mild whitening/frosting appeared.

The standard AVF cannulation procedure was performed. Pain levels were measured immediately after the procedure using VAS.

Other: Cold Aloe Vera Gel Application
1 ml of cold aloe vera gel was applied to a 5x5 cm area over the fistula site. The standard AVF cannulation procedure was conducted. Pain levels were assessed post-procedure using VAS.
Other: Standard Procedure (Control Condition)

No additional pain-relief intervention was applied. The nurse performed the standard AVF cannulation procedure, including hand hygiene, thrill assessment, and site disinfection.

Pain levels were assessed immediately after cannulation using the Visual Analog Scale (VAS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Level (VAS - Visual Analog Scale)
Time Frame: 3 months

The pain level experienced by patients after AVF cannulation was assessed using the VAS (0-10 scale).

Pain scores were recorded and compared across all three interventions. Lower VAS scores indicate greater effectiveness of the intervention in pain reduction. n this scale, patients are asked to describe their pain using numbers, where "0" represents no pain and "10" indicates the highest, unbearable pain.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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