Arteriovenous Fistula Pain and Cold Application

NCT ID: NCT06862687

Last Updated: 2025-03-11

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arteriovenous Fistula Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single Group Assignment

Three different interventions (cooling spray, aloe vera gel, and standard procedure) were applied to participants in sequence

Group Type ACTIVE_COMPARATOR

Cooling Spray

Intervention Type 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

Intervention Type 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)

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ataturk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mehtap KAVURMACI

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Atatürk Research Hospital

Erzurum, Yakutiye, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 39585227 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B.30.2.ATA.0.01.00/300

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.