Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas Street, MSC 160, Charleston, SC 29425, USA.
Medical University of South Carolina, College of Nursing, 99 Jonathan Lucas Street, MSC 160, Charleston, SC 29425, USA.
Int J Nurs Stud. 2018 Oct;86:1-10. doi: 10.1016/j.ijnurstu.2018.04.015. Epub 2018 Apr 26.
Individuals with chronic venous disease (CVeD) frequently experience associated leg pain that may influence disease management self-efficacy.
To evaluate the influence of a cooling intervention on leg pain associated with more severe stages of CVeD and self-efficacy. This was a secondary aim of the trial.
Randomized, blinded, comparator-controlled, multisite trial.
Three wound clinics and an academic medical research center in the United States of America.
276 participants (54.3% female, 46.7% male) with stage 4 and 5 CVeD were randomly assigned by computer generated tables to the cooling intervention group (n = 138) or control group (n = 138).
Participants received either a cooling (intervention) leg cuff or placebo cuff (control) to apply topically over the affected skin area. Both groups performed standard of care including wearing compression wraps and elevating legs for 30 min during the intervention. Study visits occurred at baseline, and months 1, 3, 6, and 9.
Visit measures included: Numeric Rating Scale (NRS) for short term pain; VEINES-QOL/Sym questionnaire for long-term pain; and, the Self Efficacy for Managing Chronic Disease Scale (SEMCD-6) for self-efficacy. Data were collected from September 2010 to December 2015 and analyzed using pooled t-tests, Chi-square tests, and mixed effects models. Observed 9-month patient retention rates were 94/138 (68.1%) in the intervention group and 91/138 (65.9%) in the control group. The primary analysis was based on the intention-to-treat principle.
Both the cooling intervention and control group experienced statistically significant decreases in unadjusted and adjusted mean NRS pain scores of 1.2 (95% CI: (-1.82, -0.64); p < 0.0001) and 1.8 (95% CI: (-2.31, -1.24); p < 0.0001) respectively from baseline, however, no statistically significant differences in change scores were observed between groups. The unadjusted mean VEINES-QOL/Sym pain scores had statistically significant decreases of 0.9 ((95% CI: (-1.07, -0.62) p < 0.0001 cooling)) and 0.8 (95% CI: (-1.09, -0.55) p < 0.0001 - control) points. When adjusting the scores for demographic and clinical features, both cooling and control groups maintained statistically significant decreases (p < 0.001 for both). No statistically significant differences in change scores were observed between groups. The unadjusted and adjusted mean self-efficacy scores had no statistically significant improvements from baseline to month 9 within and between the cooling and control groups.
Pain was reduced in both groups while self-efficacy did not change. Findings suggest that strictly implemented standard of CVeD care in each study group, with or without cooling, improved pain while there were no effects on self-efficacy.
患有慢性静脉疾病（CVeD）的个体经常会出现腿部疼痛，这可能会影响疾病管理的自我效能。
评估冷却干预对更严重阶段的 CVeD 相关腿部疼痛和自我效能的影响。这是该试验的次要目的。
随机、盲法、对照、多中心试验。
美国三个伤口诊所和一个学术医学研究中心。
276 名患有 4 期和 5 期 CVeD 的参与者（54.3%女性，46.7%男性）通过计算机生成的表格随机分配到冷却干预组（n=138）或对照组（n=138）。
参与者接受冷却（干预）腿套或安慰剂腿套（对照），在受影响的皮肤区域局部应用。两组均接受标准护理，包括在干预期间 30 分钟内穿戴压缩包裹和抬高腿部。研究访视在基线时以及第 1、3、6 和 9 个月进行。
访视测量包括：短期疼痛的数字评分量表（NRS）；长期疼痛的 VEINES-QOL/Sym 问卷；以及慢性疾病管理自我效能量表（SEMCD-6）的自我效能。数据于 2010 年 9 月至 2015 年 12 月收集，并使用 pooled t 检验、卡方检验和混合效应模型进行分析。观察到 9 个月的患者保留率为干预组 94/138（68.1%）和对照组 91/138（65.9%）。主要分析基于意向治疗原则。
冷却干预组和对照组的未经调整和调整后的平均 NRS 疼痛评分均有统计学意义的降低，分别为 1.2（95%置信区间：（-1.82，-0.64）；p<0.0001）和 1.8（95%置信区间：（-2.31，-1.24）；p<0.0001），但组间变化评分无统计学意义。未经调整的 VEINES-QOL/Sym 疼痛评分有统计学意义的降低，分别为 0.9（95%置信区间：（-1.07，-0.62）；p<0.0001-冷却）和 0.8（95%置信区间：（-1.09，-0.55）；p<0.0001-对照）点。在调整人口统计学和临床特征的评分后，冷却组和对照组均保持统计学意义的降低（均为 p<0.001）。组间无统计学意义的变化评分。未经调整和调整后的平均自我效能评分在冷却组和对照组的基线至第 9 个月之间均无统计学意义的改善。
两组的疼痛均有所减轻，而自我效能感则没有变化。结果表明，在每个研究组中严格实施 CVeD 标准护理，无论是否使用冷却，都可以改善疼痛，而对自我效能感没有影响。
