Thermotherapy for Reducing Pain During Arteriovenous Fistula Cannulation

NCT07662564 | Completed

• 1 other identifier: 2026/22
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Dialysis; Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Fistula Cannulation Related Pain

  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)

Study Arms (3)

Experimental Group 1

EXPERIMENTAL

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

Experimental Group 2

EXPERIMENTAL

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

Placebo Group

NO INTERVENTION

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.

Interventions

Thermotherapy application OTHER

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

Experimental Group 1; Experimental Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Nurten Özen

Fatih, İ̇stanbul, 34116, Turkey (Türkiye)

Location

Related Publications (2)

• Abramson DI, Chu LS, Tuck S Jr, Lee SW, Richardson G, Levin M. Effect of tissue temperatures and blood flow on motor nerve conduction velocity. JAMA. 1966 Dec 5;198(10):1082-8. No abstract available.

  PMID: 5953385 BACKGROUND

• Back Y, Lee Y. Optimal Time of Thermotherapy for Reducing Pain, Anxiety, and Side Effects in Arteriovenous Fistula Puncture Patients: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Sep 29;17(19):7147. doi: 10.3390/ijerph17197147.

  PMID: 33003591 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• NURTEN ÖZEN, Professor

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: April 6, 2026
• Primary Completion: May 15, 2026
• Study Completion: June 15, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)