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Completed

NCT Number: NCT07662564

Thermotherapy for Reducing Pain During Arteriovenous Fistula Cannulation

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nurten Özen

Fatih, İ̇stanbul, 34116, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Thermotherapy application

Other

Heated hot pack was hold for 5 or 10 minutes on the AVF cannulation area.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

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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