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Pre-Cannulation Ultrasound Vascular Mapping Combined With Handgrip Exercise and Local Cryotherapy in Hemodialysis Patients With Difficult Cannulation

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07842939
Enrollment
69
Registered
2026-09-25
Start date
2025-12-24
Completion date
2026-07-31
Last updated
2026-09-25

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

Conditions

Hemodialysis, Difficult Vascular Access Cannulation

Keywords

Ultrasound Vascular Mapping, Handgrip Exercise, Local Cryotherapy, Cannulation Pain, First-Attempt Cannulation Success

Brief 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. 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.

Interventions

OTHERPre-Cannulation Ultrasound Vascular Mapping

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.

Participants performed handgrip exercise before vascular access cannulation as part of the multicomponent intervention.

Local cryotherapy was applied before vascular access cannulation as part of the multicomponent intervention.

OTHERUsual Care

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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

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

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
VAS Pain ScoreBefore 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 SuccessDuring 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.

Secondary

MeasureTime frameDescription
Pain Perception ScoreBefore cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.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.
Anxiety Perception ScoreBefore cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.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.
Comfort ScoreBefore cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.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.
Overall Care Satisfaction ScoreBefore cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.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.

Countries

Taiwan

Contacts

PRINCIPAL_INVESTIGATORShu-Fen Hsieh

Chang Gung Memorial Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 26, 2026