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

NCT07842939 | Completed

• 1 other identifier: 202501448B0
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Difficult Vascular Access Cannulation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  During vascular access cannulation in the same hemodialysis session.

Secondary Outcomes (4)

• Pain Perception Score

  Before cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.

• Anxiety Perception Score

  Before cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.

• Comfort Score

  Before cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.

• Overall Care Satisfaction Score

  Before cannulation and immediately after completion of arterial and venous needle insertion in the same hemodialysis session.

Other Outcomes (1)

• Intervention Acceptability Score

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

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

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.

Intervention Group

Handgrip Exercise BEHAVIORAL

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

Intervention Group

Local Cryotherapy OTHER

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

Intervention Group

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.

Control Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Study Officials

• Shu-Fen Hsieh

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: December 24, 2025
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)