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ACTIVE NOT RECRUITING
NCT07694271
NA

Cryotherapy for Reducing Fistula Puncture Pain in Hemodialysis Patients

Sponsor: Taipei Medical University

View on ClinicalTrials.gov

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.

Official title: Efficacy of Cryotherapy in Reducing Arteriovenous Fistula Puncture Pain and Anxiety in Hemodialysis Patients: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-02-25

Completion Date

2026-06-30

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

OTHER

Usual Care (Room-Temperature Water Bag)

Placement of a room-temperature water bag at the puncture site for 5 minutes before cannulation.

DEVICE

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.

DRUG

Lidocaine/Prilocaine Gel

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

Locations (1)

Taipei Municipal Wanfang Hospital

Taipei, Taiwan