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Completed

NCT Number: NCT06862687

Arteriovenous Fistula Pain and Cold Application

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.

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Key information

Conditions

Arteriovenous Fistula Pain Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Signs and Symptoms Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk Research Hospital

Erzurum, Yakutiye, 25000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cooling Spray

Other

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.

Cold Aloe Vera Gel Application

Other

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.

Standard Procedure (Control Condition)

Other

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).

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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