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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- VAS Pain Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention Group
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.
干预措施: Pre-Cannulation Ultrasound Vascular Mapping (Other)
Intervention Group
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.
干预措施: Handgrip Exercise (Behavioral)
Intervention Group
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.
干预措施: Local Cryotherapy (Other)
Control Group
Participants in the control group received usual care, including routine visual inspection and palpation before vascular access cannulation, without the multicomponent intervention.
干预措施: Usual Care (Other)
结局指标
主要结局
VAS Pain Score
时间窗: 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
时间窗: 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.
次要结局
- 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.)