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Thermotherapy for Reducing Pain During Arteriovenous Fistula Cannulation

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07662564
Enrollment
51
Registered
2026-06-23
Start date
2026-04-06
Completion date
2026-06-15
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis, Pain

Brief summary

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.

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). Investigators hypothesized that the 5 minutes thermotherapy is the optimal time to alleviate the patients' fistula cannulation related pain.

Interventions

OTHERThermotherapy application

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

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline Fistula Cannulation Related PainUp 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

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORNURTEN ÖZEN, Professor

Istanbul University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026