HemodialysisNCT07842939
Pre-Cannulation Ultrasound Vascular Mapping Combined With Handgrip Exercise and Local Cryotherapy in Hemodialysis Patients With Difficult Cannulation
A study testing Pre-Cannulation Ultrasound Vascular Mapping, Handgrip Exercise and Local Cryotherapy in people with Hemodialysis and Difficult Vascular Access Cannulation, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This pilot randomized controlled trial evaluated a multicomponent intervention for adult maintenance hemodialysis patients with difficult vascular access cannulation. Participants were randomly assigned to an intervention group or a usual-care control group. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hemodialysis, Difficult Vascular Access Cannulation
- What is being tested?
- Pre-Cannulation Ultrasound Vascular Mapping, Handgrip Exercise and Local Cryotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Dec 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20 years or older.
- Receiving maintenance hemodialysis for at least 3 months.
- Having an arteriovenous fistula or arteriovenous graft for hemodialysis vascular access.
- Having difficult vascular access cannulation, defined as requiring two or more cannulation attempts during at least one of the two most recent hemodialysis sessions.
- Able to understand the study information and provide written informed consent.
Who cannot join
- Newly created vascular access that had not yet matured or was not clinically stable for routine cannulation.
- Acute or clinically unstable medical condition.
- Cognitive or language impairment that prevented completion of the study questionnaires.
- Contraindication to local cryotherapy or handgrip exercise.
- Previous participation in this study or in the study pretest.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pre-Cannulation Ultrasound Vascular Mapping Combined With Handgrip Exercise and Local Cryotherapy on Pain, Anxiety, Comfort, Satisfaction, and Cannulation Success in Hemodialysis Patients With Difficult Cannulation: A Pilot Randomized Controlled Trial
This pilot randomized controlled trial evaluated a multicomponent intervention for adult maintenance hemodialysis patients with difficult vascular access cannulation. Participants were randomly assigned to an intervention group or a usual-care control group. The intervention included pre-cannulation ultrasound vascular mapping, handgrip exercise, and local cryotherapy before vascular access cannulation. The study assessed visual analog scale pain, first-attempt cannulation success, perceived pain, anxiety, comfort, and overall care satisfaction. Participants in the intervention group also evaluated the acceptability of the intervention.
- Being tested
- Pre-Cannulation Ultrasound Vascular Mapping, Handgrip Exercise, Local Cryotherapy, Usual Care
- Keywords
- Ultrasound Vascular Mapping, Handgrip Exercise, Local Cryotherapy, Cannulation Pain, First-Attempt Cannulation Success
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Cannulation Ultrasound Vascular MappingOther
Pre-cannulation ultrasound vascular mapping was performed before vascular access cannulation to assess vessel course, depth, blood flow, and suitable cannulation areas. The vascular map was provided as a reference for the cannulating nurse when selecting the cannulation site. Routine visual inspection and palpation were also performed before cannulation.
Handgrip ExerciseBehavioural
Participants performed handgrip exercise before vascular access cannulation as part of the multicomponent intervention.
Local CryotherapyOther
Local cryotherapy was applied before vascular access cannulation as part of the multicomponent intervention.
Usual CareOther
Participants in the control group received usual care, including routine visual inspection and palpation of the vascular access before cannulation. They did not receive pre-cannulation ultrasound vascular mapping, handgrip exercise, or local cryotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group received pre-cannulation ultrasound vascular mapping, handgrip exercise, and local cryotherapy in addition to routine visual inspection and palpation before vascular access cannulation. Receives: Other: Pre-Cannulation Ultrasound Vascular Mapping; Behavioral: Handgrip Exercise; Other: Local Cryotherapy |
| Control Group | Active comparator | Participants in the control group received usual care, including routine visual inspection and palpation before vascular access cannulation, without the multicomponent intervention. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Pain Score
Pain intensity was assessed using a 0-10 visual analog scale (VAS), with higher scores indicating greater pain. VAS pain was measured before vascular access cannulation and immediately after completion of arterial and venous needle insertion.
Measured: Before cannulation and immediately after completion of arterial and venous needle insertion on the same hemodialysis session.
First-Attempt Cannulation Success
First-attempt cannulation success was defined as successful placement of both arterial and venous needles on the first attempt. If either needle required repeat cannulation and the total number of needle insertions exceeded two, the cannulation was classified as unsuccessful on the first attempt.
Measured: During vascular access cannulation in the same hemodialysis session.
Secondary outcomes (4)
Pain Perception Score
Pain perception was assessed using a 5-item questionnaire. Each item was rated on a 4-point Likert scale, with a total score ranging from 5 to 20. Higher scores indicated greater pain perception. The scale was administered before vascular access cannulation and immediately after completion of arterial and venous needle insertion.
Measured: Before cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.
Anxiety Perception Score
Anxiety perception was assessed using a 5-item questionnaire. Each item was rated on a 4-point Likert scale, with a total score ranging from 5 to 20. Higher scores indicated greater anxiety perception. The scale was administered before vascular access cannulation and immediately after completion of arterial and venous needle insertion.
Measured: Before cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.
Comfort Score
Comfort was assessed using a 4-item questionnaire. Each item was rated on a 4-point Likert scale, with a total score ranging from 4 to 16. Higher scores indicated greater comfort. The scale was administered before vascular access cannulation and immediately after completion of arterial and venous needle insertion.
Measured: Before cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.
Overall Care Satisfaction Score
Overall care satisfaction was assessed using a 6-item questionnaire. Each item was rated on a 4-point Likert scale, with a total score ranging from 6 to 24. Higher scores indicated greater satisfaction with overall care. The scale was administered before vascular access cannulation and immediately after completion of arterial and venous needle insertion.
Measured: Before cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start24 Dec 2025
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Fen Hsieh, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842939
- Sponsor's protocol ID
- 202501448B0
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because data sharing was not included in the original study protocol or informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-Cannulation Ultrasound Vascular Mapping Combined With Handgrip Exercise and Local Cryotherapy on Pain, Anxiety, Comfort, Satisfaction, and Cannulation Success in Hemodialysis Patients With Difficult Cannulation: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07842939
- Acronym / sponsor ID
- 202501448B0
- Keywords
- Ultrasound Vascular Mapping, Handgrip Exercise, Local Cryotherapy, Cannulation Pain, First-Attempt Cannulation Success
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 25 Sep 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.
This pilot randomized controlled trial evaluated a multicomponent intervention for adult maintenance hemodialysis patients with difficult vascular access cannulation. Participants were randomly assigned to an intervention group or a usual-care control group. The intervention included pre-cannulation ultrasound vascular mapping, handgrip exercise, and local cryotherapy before vascular access cannulation. The study assessed visual analog scale pain, first-attempt cannulation success, perceived pain, anxiety, comfort, and overall care satisfaction. Participants in the intervention group also evaluated the acceptability of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Pre-Cannulation Ultrasound Vascular Mapping, Behavioral: Handgrip Exercise, Other: Local CryotherapyParticipants in the intervention group received pre-cannulation ultrasound vascular mapping, handgrip exercise, and local cryotherapy in addition to routine visual inspection and palpation before vascular access cannulation. |
| Control Group | Active comparator | Other: Usual CareParticipants in the control group received usual care, including routine visual inspection and palpation before vascular access cannulation, without the multicomponent intervention. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 20 years or older.
- Receiving maintenance hemodialysis for at least 3 months.
- Having an arteriovenous fistula or arteriovenous graft for hemodialysis vascular access.
- Having difficult vascular access cannulation, defined as requiring two or more cannulation attempts during at least one of the two most recent hemodialysis sessions.
- Able to understand the study information and provide written informed consent.
Key exclusion criteria (5 listed)
- Newly created vascular access that had not yet matured or was not clinically stable for routine cannulation.
- Acute or clinically unstable medical condition.
- Cognitive or language impairment that prevented completion of the study questionnaires.
- Contraindication to local cryotherapy or handgrip exercise.
- Previous participation in this study or in the study pretest.
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 |
|---|---|---|
| Pre-Cannulation Ultrasound Vascular MappingPre-cannulation ultrasound vascular mapping was performed before vascular access cannulation to assess vessel course, depth, blood flow, and suitable cannulation areas. The vascular map was provided as a reference for the cannulating nurse when selecting the cannulation site. Routine visual inspection and palpation were also performed before cannulation. | Other | Intervention Group |
| Handgrip ExerciseParticipants performed handgrip exercise before vascular access cannulation as part of the multicomponent intervention. | Behavioural | Intervention Group |
| Local CryotherapyLocal cryotherapy was applied before vascular access cannulation as part of the multicomponent intervention. | Other | Intervention Group |
| Usual CareParticipants in the control group received usual care, including routine visual inspection and palpation of the vascular access before cannulation. They did not receive pre-cannulation ultrasound vascular mapping, handgrip exercise, or local cryotherapy. | Other | Control Group |
Primary outcome
VAS Pain Score
Time frame: Before cannulation and immediately after completion of arterial and venous needle insertion on the same hemodialysis session.
Pain intensity was assessed using a 0-10 visual analog scale (VAS), with higher scores indicating greater pain. VAS pain was measured before vascular access cannulation and immediately after completion of arterial and venous needle insertion.
First-Attempt Cannulation Success
Time frame: During vascular access cannulation in the same hemodialysis session.
First-attempt cannulation success was defined as successful placement of both arterial and venous needles on the first attempt. If either needle required repeat cannulation and the total number of needle insertions exceeded two, the cannulation was classified as unsuccessful on the first attempt.
4 secondary outcomes
Pain Perception Score
Time frame: Before cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.
Anxiety Perception Score
Time frame: Before cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.
Comfort Score
Time frame: Before cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.
Overall Care Satisfaction Score
Time frame: Before cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because data sharing was not included in the original study protocol or informed consent.
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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.
Shu-Fen Hsieh principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Cannulation Ultrasound Vascular Mapping, Handgrip Exercise and Local Cryotherapy in people with Hemodialysis and Difficult Vascular Access Cannulation, run by Chang Gung Memorial Hospital 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 25 Sep 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VAS Pain Score (time frame: Before cannulation and immediately after completion of arterial and venous needle insertion on the same hemodialysis session.). The study lists 2 primary outcomes in all. 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 25 Sep 2026.