Cryotherapy for Reducing Fistula Puncture Pain in Hemodialysis Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Usual Care (Room-Temperature Water Bag): Placement of a room-temperature water bag at the puncture site for 5 minutes before cannulation.

Cryotherapy (Ice Pack): Application of a 200g ice pack wrapped in a single layer of cotton cloth to the LI4 (Hegu) acupoint on the non-fistula hand for 5 minutes before cannulation.

Lidocaine/Prilocaine Gel: Topical application of lidocaine/prilocaine gel to two puncture areas under an occlusive dressing for up to 1 hour before cannulation.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Puncture-Related Pain Severity — Measured at 4 time points (pre-puncture, post-puncture, during dialysis, post-dialysis) over each of 3 consecutive hemodialysis sessions, up to approximately 1 week
  Pain severity related to arteriovenous fistula puncture, assessed using the pain item of the Edmonton Symptom Assessment Scale-revised (ESAS-r), a 0-10 numeric rating scale where higher scores indicate greater pain severity.

Trial sites (1)

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