Thermotherapy for Reducing Pain During Arteriovenous Fistula Cannulation

June 17, 2026 updated by: Nurten Ozen, Istanbul University

Optimal Time of Thermotherapy for Reducing Arteriovenous Fistula Cannulation Related Pain: A Three-Arm, Placebo-Controlled, Randomized Trial

Arteriovenous fistula (AVF) cannulation is a routine procedure for people receiving haemodialysis and is frequently associated with pain. Thermotherapy has been reported as an effective non-pharmacological intervention for reducing AVF cannulation-related pain; however, the optimal application duration remains unclear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thermotherapy is the therapeutic application of any substance to the body that adds heat to the body resulting in increased tissue temperature. Thermotherapy increases tissue tem-perature, blood flow, metabolism, and connective tissue extensibility. Some of the benefits provided by topical heat therapy may be mediated di¬rectly in the brain. Functional brain imag¬ing research has revealed central ef¬fects of non-noxious skin warming with increased activation of the thalamus and posterior insula of the brain. In addition, innocuous tactile stimulation of the skin activates the thalamus and S2 region of the cerebral cortex. These direct effects on the brain may mitigate the sensation of pain in the brain, thereby providing pain relief. Two studies were found in the literature evaluating the effect of thermotherapy on fistula-related cannulation pain. In both studies, thermotherapy treatment was found to be effective in reducing pain. Although it is stated in the literature that thermotherapy can be applied for 5-30 minutes , research shows that it is applied for 15 minutes, 10 minutes and 20 minutes. Thermotherapy was administered in three sessions, and in one session. This randomized controlled trial was conducted to evaluate the effectiveness of different application durations (5 and 10 minutes) of thermotherapy on reducing pain during AVF cannulation for long period (12 dialysis sessions). We hypothesized that the 5 minutes thermotherapy is the optimal time to alleviate the patients' fistula cannulation related pain.

Study Type

Interventional

Enrollment (Actual)

51

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 (Türkiye)
    • İ̇stanbul
      • Fatih, İ̇stanbul, Turkey (Türkiye), 34116
        • Nurten Özen

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:

  • Patients aged 18 years and older
  • Patients who received hemodialysis (HD) treatment with an arteriovenous fistula (AVF) for at least 3 months
  • Patients receiving HD treatment 3 days a week for 4 hours each session
  • Patients with a pain score of ⩾1 during AVF cannulation, measured by a visual analog scale (VAS)
  • Patients able to communicate in Turkish
  • Patients without psychiatric disorders that impair communication
  • Patients who agreed to participate in the study

Exclusion Criteria:

  • Patients who were known to present difficulties with fistula cannulation (requiring multiple cannulations)
  • Patients with a history of hematoma or stenosis in the arteriovenous fistula (AVF)
  • Patients with an infection at the fistula site
  • Patients who took painkillers within 3 hours prior to treatment
  • Hypersensitivity reactions and circulatory disorders due to thermotherapy
  • Sensory or cognitive impairment preventing a proper assessment of pain
  • Patients who did not wish to participate in the study

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group 1
Heated hot pack was hold for 5 minutes on the AVF cannulation area. After 5 minutes the area was cleaned with a disinfection and cannulation was done by the nurse.
Other: Thermotherapy application
Heated hot pack was hold for 5 or 10 minutes on the AVF cannulation area.
Experimental: Experimental Group 2
Heated hot pack was hold for 10 minutes on the AVF cannulation area. After 10 minutes the area was cleaned with a disinfection and cannulation was done by the nurse.
Other: Thermotherapy application
Heated hot pack was hold for 5 or 10 minutes on the AVF cannulation area.
No Intervention: Placebo Group
Not heated hot pack was hold for 10 minutes on the AVF cannulation area. After 10 minutes the area was cleaned with a disinfection and cannulation was done by the nurse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Fistula Cannulation Related Pain
Time Frame: Up to 2 weeks (3 hemodialysis sessions in a week)
It will be assessed six times at the end of the dialysis session with Visual Analogue Scale. Visual Analogue Scale ranging from 0 (no pain) to 10 (worst pain). Pain increases the score increases. The high point describes bad outcome
Up to 2 weeks (3 hemodialysis sessions in a week)

Collaborators and Investigators

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

Sponsor

Istanbul University

Investigators

  • Principal Investigator: NURTEN ÖZEN, Professor, Istanbul 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)

April 6, 2026

Primary Completion (Actual)

May 15, 2026

Study Completion (Actual)

June 15, 2026

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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