Pain, Procedural (During Sternum Dressing on Infants)CRYO-AVFNCT07694271
Cryotherapy for Reducing Fistula Puncture Pain in Hemodialysis Patients
A study testing Cryotherapy (Ice Pack) and Lidocaine/Prilocaine Gel in people with Pain, Procedural (During Sternum Dressing on Infants) and Arteriovenous Fistula, run by Taipei Medical University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Procedural (During Sternum Dressing on Infants), Arteriovenous Fistula, Kidney Failure, Chronic
- What is being tested?
- Cryotherapy (Ice Pack) and Lidocaine/Prilocaine Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Feb 2025to 24 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Usual care: application of a room-temperature water bag to the puncture site for 5 minutes before cannulation.
- 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.
- 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.
- Conditions
- Pain, Procedural (During Sternum Dressing on Infants), Arteriovenous Fistula, Kidney Failure, Chronic
- Being tested
- Usual Care (Room-Temperature Water Bag), Cryotherapy (Ice Pack), Lidocaine/Prilocaine Gel
- Keywords
- Cryotherapy, Hemodialysis, Puncture Pain, Lidocaine-Prilocaine, Anxiety, Arteriovenous Fistula Cannulation
- Medical subject headings
- Pain, Arteriovenous Fistula, Kidney Failure, Chronic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care (Room-Temperature Water Bag)Other
Placement of a room-temperature water bag at the puncture site for 5 minutes before cannulation.
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.
Lidocaine/Prilocaine GelDrug
Topical application of lidocaine/prilocaine gel to two puncture areas under an occlusive dressing for up to 1 hour before cannulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Lidocaine/Prilocaine Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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: 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
Quality 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.
Measured: Measured before dialysis, after dialysis, and before the next dialysis session, up to approximately 1 week
Sympathetic Nervous System Activity
Objective measurement of sympathetic nervous system activity using a heart rate variability (HRV) monitoring device, reflecting physiological stress response.
Measured: Measured before dialysis, after dialysis, and before the next dialysis session, up to approximately 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start25 Feb 2025
- Primary completion24 Jul 2026 (estimated)
- Study completion24 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, Procedural (During Sternum Dressing on Infants)Studies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsai-Wei Huang, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694271
- Sponsor's protocol ID
- Cryotherapy_Hemodialysis
- Other IDs
- IRB Approval Number
- Acronym
- CRYO-AVF
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cryotherapy in Reducing Arteriovenous Fistula Puncture Pain and Anxiety in Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07694271
- Acronym / sponsor ID
- CRYO-AVF / Cryotherapy_Hemodialysis
- Conditions
- Pain, Procedural (During Sternum Dressing on Infants), Arteriovenous Fistula, Kidney Failure, Chronic
- Keywords
- Cryotherapy, Hemodialysis, Puncture Pain, Lidocaine-Prilocaine, Anxiety, Arteriovenous Fistula Cannulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 24 Jul 2026 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Usual care: application of a room-temperature water bag to the puncture site for 5 minutes before cannulation.
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Sham comparator | Other: Usual Care (Room-Temperature Water Bag)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. |
| Cryotherapy | Experimental | 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, over three consecutive hemodialysis sessions. |
| Lidocaine/Prilocaine Gel | Active comparator | Drug: Lidocaine/Prilocaine GelApplication of lidocaine/prilocaine gel to two puncture areas under an occlusive dressing for up to 1 hour before cannulation, over three consecutive hemodialysis sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Care (Room-Temperature Water Bag)Placement of a room-temperature water bag at the puncture site for 5 minutes before cannulation. | Other | Usual Care |
| 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. | Device | Cryotherapy |
| Lidocaine/Prilocaine GelTopical application of lidocaine/prilocaine gel to two puncture areas under an occlusive dressing for up to 1 hour before cannulation. | Drug | Lidocaine/Prilocaine Gel |
Primary outcome
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.
3 secondary outcomes
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
Health-Related Quality of Life
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy (Ice Pack) and Lidocaine/Prilocaine Gel in people with Pain, Procedural (During Sternum Dressing on Infants) and Arteriovenous Fistula, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.