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NCT Number: NCT07842939

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

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.

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Key information

Conditions

Hemodialysis Difficult Vascular Access Cannulation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pre-Cannulation Ultrasound Vascular Mapping

Other

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 Exercise

Behavioral

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

Local Cryotherapy

Other

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

Usual Care

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Pain Perception Score

    Time frame: Before 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.

  2. Anxiety Perception Score

    Time frame: Before 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.

  3. Comfort Score

    Time frame: Before 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.

  4. Overall Care Satisfaction Score

    Time frame: Before 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.

Other outcomes

  1. Intervention Acceptability Score

    Time frame: Immediately after completion of the intervention and vascular access cannulation in the same hemodialysis session.

    Acceptability of the multicomponent intervention was assessed in the intervention group 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 acceptability of the intervention.

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Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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