Cryotherapy for Reducing Fistula Puncture Pain in Hemodialysis Patients
Active, not recruitingNot applicableNCT07694271
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
People on hemodialysis need their arteriovenous fistula (a blood vessel access point) punctured with a needle three times a week, which can cause pain and worry. This study compares three ways of managing that pain: (1) usual care, (2) applying an ice pack to a specific point on the hand before the needle is inserted (cryotherapy), and (3) applying a numbing gel (lidocaine/prilocaine) to the skin before the needle is inserted. Adult hemodialysis patients with a working fistula were randomly assigned to one of these three groups. Over three dialysis sessions, researchers measured each patient's pain, anxiety, and other symptoms right before, right after, during, and after dialysis, as well as their quality of life and a physical stress marker (heart rate variability). The goal is to find out whether the ice pack method works as well as or better than usual care and the numbing gel at reducing pain and anxiety, so that a simple, low-cost, non-drug option could be offered to more patients in the future.
Study details
- Official title
- Efficacy of Cryotherapy in Reducing Arteriovenous Fistula Puncture Pain and Anxiety in Hemodialysis Patients: A Randomized Controlled Trial
- Conditions
- Pain, Procedural (During Sternum Dressing on Infants)
- Arteriovenous Fistula
- Kidney Failure, Chronic
- Interventions
- Other: Usual Care (Room-Temperature Water Bag)
- Device: Cryotherapy (Ice Pack)
- Drug: Lidocaine/Prilocaine Gel
- Sponsor
- Taipei Medical University
- Start date
- 2025-02-25
- Primary completion
- 2026-07-24
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Taiwan
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age 18 years or older * Diagnosed with end-stage renal disease requiring long-term hemodialysis * Receiving hemodialysis with no hospitalization or arteriovenous fistula-related complications (e.g., infection, steal syndrome, aneurysm, pseudoaneurysm) within the past month * Has a functioning arteriovenous fistula access (adequate vessel diameter, elastic and intact vessel wall, no significant stenosis or occlusion, superficial location, healthy surrounding tissue) * Clear consciousness and able to express pain sensation, with no psychiatric symptoms interfering with communication * Able to communicate in Mandarin or Taiwanese Exclusion Criteria: * Not using an arteriovenous fistula for dialysis vascular access * History of stroke or peripheral neuropathy/sensory abnormality (e.g., numbness, tingling) * Confused consciousness, unable to clearly express pain sensation * Dysfunctional fistula, deep vein thrombosis, or cannulation difficulty preventing full use of the arteriovenous fistula
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07694271