Cryotherapy for Reducing Fistula Puncture Pain in Hemodialysis Patients (CRYO-AVF)

July 2, 2026 updated by: Tsai-Wei Huang, Taipei Medical University

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Patients undergoing chronic hemodialysis require repeated arteriovenous fistula (AVF) cannulation, typically three times per week, resulting in over 300 needle punctures per year. Puncture-related pain and anxiety are common and can contribute to treatment avoidance and reduced quality of life. Cryotherapy has been proposed in prior literature as a simple, inexpensive, non-pharmacological method to reduce puncture-related pain by slowing nerve conduction velocity, but its comparative effectiveness against topical anesthetic gel and usual care has not been well established in clinical practice.

Objective: To compare the effectiveness of cryotherapy, topical lidocaine/prilocaine gel, and usual care in reducing AVF puncture-related pain and anxiety among hemodialysis patients, and to evaluate their effects on quality of life and physiological stress response.

Design: This is a randomized controlled trial with three parallel arms. Eligible participants were randomly assigned by dice-roll allocation to one of three groups:

  1. Usual care: application of a room-temperature water bag to the puncture site for 5 minutes before cannulation.
  2. Cryotherapy: 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.
  3. Topical anesthetic: application of lidocaine/prilocaine gel to two puncture areas under an occlusive dressing for up to 1 hour before cannulation.

All participants underwent the same cannulation procedure performed by the same operator using a 16Fr fistula needle, over three consecutive dialysis sessions (three times per week). Outcome assessors collecting data were blinded to group assignment.

Outcome Measures: Pain and symptom distress were assessed using the Edmonton Symptom Assessment Scale-revised (ESAS-r, 10 items) at four time points (pre-puncture, post-puncture, during dialysis, post-dialysis) across all three sessions. Quality of life was assessed using the EQ-5D-5L before dialysis, after dialysis, and before the next dialysis session. Heart rate variability (HRV), as an objective marker of sympathetic nervous system activity, was measured at the same time points as the EQ-5D-5L. Vital signs, dialysis blood flow rate, and pre/post-dialysis body weight were also recorded.

Statistical Analysis: Descriptive statistics (means, standard deviations, frequencies, percentages) were used to summarize demographic and clinical characteristics. Between-group comparisons were conducted using t-tests, chi-square tests, and two-way ANOVA to evaluate the effects of the interventions on pain, anxiety, and quality-of-life outcomes.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Municipal Wanfang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Usual Care
Application of a room-temperature water bag to the puncture site for 5 minutes before cannulation, over three consecutive hemodialysis sessions. This condition matches the application procedure of the cryotherapy arm without a cooling effect.
Other: Usual Care (Room-Temperature Water Bag)
Placement of a room-temperature water bag at the puncture site for 5 minutes before cannulation.
Experimental: Cryotherapy
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, over three consecutive hemodialysis sessions.
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.
Active Comparator: Lidocaine/Prilocaine Gel
Application of lidocaine/prilocaine gel to two puncture areas under an occlusive dressing for up to 1 hour before cannulation, over three consecutive hemodialysis sessions.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Puncture-Related Pain Severity
Time Frame: 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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Distress
Time Frame: 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
Overall symptom distress assessed using the 10-item Edmonton Symptom Assessment Scale-revised (ESAS-r), covering symptoms such as anxiety, fatigue, and other physical and emotional distress, each rated 0-10, with higher scores indicating greater distress.
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
Health-Related Quality of Life
Time Frame: Measured before dialysis, after dialysis, and before the next dialysis session, up to approximately 1 week
Quality of life assessed using the EQ-5D-5L, a standardized instrument measuring 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) plus a visual analogue scale for overall health state; higher index scores indicate better quality of life.
Measured before dialysis, after dialysis, and before the next dialysis session, up to approximately 1 week
Sympathetic Nervous System Activity
Time Frame: Measured before dialysis, after dialysis, and before the next dialysis session, up to approximately 1 week
Objective measurement of sympathetic nervous system activity using a heart rate variability (HRV) monitoring device, reflecting physiological stress response.
Measured before dialysis, after dialysis, and before the next dialysis session, up to approximately 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cryotherapy_Hemodialysis
  • IRB Approval Number (Other Identifier: TMU-JIRB N202410073)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Failure, Chronic

Clinical Trials on Usual Care (Room-Temperature Water Bag)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe