Cryotherapy for Reducing Fistula Puncture Pain in Hemodialysis Patients

NCT07694271 | Active Not Recruiting

• 2 other identifiers: Cryotherapy_HemodialysisIRB Approval Number
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Puncture-Related Pain Severity

  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 Outcomes (3)

• Symptom 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

  Measured before dialysis, after dialysis, and before the next dialysis session, up to approximately 1 week

• Sympathetic Nervous System Activity

  Measured before dialysis, after dialysis, and before the next dialysis session, up to approximately 1 week

Study Arms (3)

Usual Care

SHAM COMPARATOR

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)

Cryotherapy

EXPERIMENTAL

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)

Lidocaine/Prilocaine Gel

ACTIVE COMPARATOR

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

Interventions

Usual Care (Room-Temperature Water Bag) OTHER

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

Usual Care

Cryotherapy (Ice Pack) DEVICE

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.

Cryotherapy

Lidocaine/Prilocaine Gel DRUG

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

Lidocaine/Prilocaine Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Pain; Arteriovenous Fistula; Kidney Failure, Chronic; Anxiety Disorders

Interventions

Cryotherapy; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Nursing

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: February 25, 2025
• Primary Completion: July 24, 2026
• Study Completion: July 24, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)