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Cryotherapy for Reducing Fistula Puncture Pain in Hemodialysis Patients

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07694271
Acronym
CRYO-AVF
Enrollment
150
Registered
2026-07-09
Start date
2025-02-25
Completion date
2026-07-24
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Fistula, Kidney Failure, Chronic, Pain, Procedural (During Sternum Dressing on Infants)

Keywords

Cryotherapy, Hemodialysis, Puncture Pain, Lidocaine-Prilocaine, Anxiety, Arteriovenous Fistula Cannulation

Brief 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.

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.

Interventions

OTHERUsual Care (Room-Temperature Water Bag)

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

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.

DRUGLidocaine/Prilocaine Gel

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

Sponsors

Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Data collectors assessing pain, anxiety, and other outcomes were blinded to group allocation; blinding of participants and intervention providers was not feasible due to the visible nature of the interventions (ice pack vs. topical gel vs. usual care).

Intervention model description

Participants were randomly allocated by dice-roll to one of three parallel groups: usual care, cryotherapy, or topical lidocaine/prilocaine gel, with each group receiving its assigned intervention over three consecutive hemodialysis sessions.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Puncture-Related Pain SeverityMeasured at 4 time points (pre-puncture, post-puncture, during dialysis, post-dialysis) over each of 3 consecutive hemodialysis sessions, up to approximately 1 weekPain 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.

Secondary

MeasureTime frameDescription
Symptom DistressMeasured at 4 time points (pre-puncture, post-puncture, during dialysis, post-dialysis) over each of 3 consecutive hemodialysis sessions, up to approximately 1 weekOverall 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.
Health-Related Quality of LifeMeasured before dialysis, after dialysis, and before the next dialysis session, up to approximately 1 weekQuality of life assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L), a standardized instrument measuring 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), converted to a utility index score ranging from approximately -0.024 to 1 (Taiwan value set), where higher scores indicate better health-related quality of life.
Sympathetic Nervous System ActivityMeasured before dialysis, after dialysis, and before the next dialysis session, up to approximately 1 weekObjective measurement of sympathetic nervous system activity using a heart rate variability (HRV) monitoring device, reflecting physiological stress response.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026