Clinical trial NCT06862687: Arteriovenous Fistula Pain and Cold Application
Official title: The Effect of Cold Application Using Two Different Methods on Arteriovenous Fistula Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Fistula Pain
Keywords: Arteriovenous Fistula
cold application
Hemodialysis
Kidney Failure
Pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Level (VAS - Visual Analog Scale)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk Research Hospital
state: Yakutiye
Study officials:
References:
citation: Thompson J, Steinheiser MM, Hotchkiss JB, Davis J, DeVries M, Frate K, Helm R, Jungkans CW, Kakani S, Lau S, Lindell K, Landrum KM, McQuillan KA, Shannon DJ, Wuerz L, Pitts S. Standards of care for peripheral intravenous catheters: evidence-based expert consensus. Br J Nurs. 2024 Nov 21;33(21):S32-S46. doi: 10.12968/bjon.2024.0422.