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首页> 外文学位 >Feasibility Study of a Randomized Controlled Trial Protocol to Examine the Effectiveness of Auriculotherapy (AT) in Improving Sleep Condition and Glycaemic Control in Clients with Type 2 Diabetes.
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Feasibility Study of a Randomized Controlled Trial Protocol to Examine the Effectiveness of Auriculotherapy (AT) in Improving Sleep Condition and Glycaemic Control in Clients with Type 2 Diabetes.

机译：一项随机对照试验方案的可行性研究，以检查耳穴疗法（AT）改善2型糖尿病患者睡眠状况和血糖控制的有效性。

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摘要

There is increasing evidence to suggest the possibly negative impact of poor sleep condition on glycemic control among patients suffering from type 2 diabetes. As maintaining an optimal glycemic control is the goal of treatment for type 2 patients, such a relationship between sleep and glycemic control suggests the possible beneficial effect of auriculotherapy for promoting sleep on disease management for type 2 diabetes.;The purpose of this study is two-fold. First, it aimed to explore the relationship between quality of sleep and glycemic control among patients with type 2 diabetes. Second, the study examined the feasibility and preliminary effects of sleep-inducing auriculotherapy on sleep quality and glycemic control among patients with type 2 diabetes.;The study was conducted in two phases. Phase 1 was a cross-sectional descriptive study to assess the association of sleep condition and glycemic control among patients with type 2 diabetes. The subjects were recruited from one general hospital and five family medicine clinics in Hong Kong. The sleep quality and glycemic control were measured by the Chinese version of Pittsburgh Sleep Quality Index (CPSQI) and hemoglobin A1c respectively. Data analysis was performed using the Statistical Package for Social Sciences version 18. Multivariable regression was used to assess the association between hemoglobin A1c and CPSQI with adjustment for demographics and medical condition, including age, sex, time since diagnosis of the diabetes and anti-diabetic treatment received.;Phase 2 was a three-arm experimental study comparing the effects of three interventions including: i) sleep-inducing auriculotherapy using magnetic pellets, ii) attention-placebo using semen vaccariae, and iii) no-treatment control on the sleep quality and quantity as well as glycemic control in patients with type 2 diabetes. A total of 60 eligible patients recruited from the hospital were randomly assigned to the three study groups. Same measurement as Phase 1 was used to measure the study outcomes in 4 time-points including baseline, post-treatment, 1 month and 3 months after treatment. Actiwatch was also used to measure the total sleep time and sleep efficiency. Generalized estimating equations (GEE) models were employed to adjust demographic characteristics and other possibly confounding variables for comparing the changes on various outcomes across the time points. The feasibility of auriculotherapy, in terms of acceptability to patients and appropriateness to apply in the clinical setting, was also assessed.;A total of 548 subjects were recruited in Phase 1 with mean age as 63 +/- 10.8 years and 46% were male. The mean diabetes duration was 9 years. Majority of them (77%) were using oral anti-diabetic drugs as the treatment modality. The mean hemoglobin A1c level was 7.3% and mean PSQI at 5.9. After adjusting for the clinical and demographic factors, poor sleep condition was found to be significantly associated with higher A1c level (p<0.05). For Phase 2 study, 60 eligible subjects were recruited. Significant improvement in CPSQI score was detected immediately after completion of auriculotherapy with magnetic pellet and semen vaccariae. The positive effect remained after 3 months of treatment. As for HbA1c, the study only indicated a non-significant trend of reduction after the treatment. Apart from the treatment effect, sleep-inducing auriculotherapy was well received by the subjects and no serious adverse effect and complaint were received. Moreover, auriculotherapy was a simple and not time-consuming procedure.;The study has advanced knowledge on the role of lifestyle factor, particularly sleep quality, on disease control among Chinese patients with type 2 diabetes. Using Traditional Chinese Medicine (TCM) approach, such as the well-known auriculotherapy, is a supplement intervention to improve the sleep condition of diabetic patients. This intervention also has a beneficial effect on their glycemic control. Results of this feasibility study indicated that the auriculotherapy was a safe and appropriate clinical practice for both the patients and the nursing practice environment. The findings also imply the grounds to conduct a more stringent evaluation on the effects of sleep-inducing auriculotherapy on glycemic control in a study with adequate power.
机译：越来越多的证据表明，不良睡眠条件可能对2型糖尿病患者的血糖控制产生负面影响。由于维持最佳血糖控制是2型糖尿病患者的治疗目标，因此睡眠与血糖控制之间的这种关系表明，耳针疗法促进睡眠对2型糖尿病的疾病治疗可能具有有益的作用。本研究的目的是两个-折。首先，它旨在探讨2型糖尿病患者的睡眠质量与血糖控制之间的关系。其次，本研究探讨了诱导睡眠的耳穴疗法对2型糖尿病患者的睡眠质量和血糖控制的可行性和初步效果。该研究分两个阶段进行。第1阶段是一项横断面描述性研究，旨在评估2型糖尿病患者的睡眠状况与血糖控制之间的关系。这些受试者是从香港的一家综合医院和五家家庭医学诊所招募的。睡眠质量和血糖控制分别通过中文版的匹兹堡睡眠质量指数（CPSQI）和血红蛋白A1c进行测量。使用《社会科学统计软件包》第18版进行数据分析。多变量回归用于评估血红蛋白A1c和CPSQI之间的关联，并调整人口统计学和医学状况，包括年龄，性别，自诊断糖尿病以来的时间和抗糖尿病药第2阶段是一项三臂实验研究，比较了三种干预措施的效果，这些干预措施包括：i）使用磁丸的睡眠诱导耳穴疗法； ii）精液疫苗治疗注意安慰剂； iii）对睡眠的无治疗控制2型糖尿病患者的质量和数量以及血糖控制。从医院招募的总共60名合格患者被随机分配到三个研究组中。与第1阶段相同的测量用于测量4个时间点的研究结果，包括基线，治疗后，治疗后1个月和3个月。 Actiwatch还用于测量总睡眠时间和睡眠效率。使用广义估计方程（GEE）模型来调整人口统计特征和其他可能混淆的变量，以比较各个时间点上各种结果的变化。从患者的可接受性和适用于临床环境的角度，评估了耳腔疗法的可行性。;第一阶段共招募了548名受试者，平均年龄为63 +/- 10.8岁，男性为46％ 。平均糖尿病病程为9年。他们中的大多数（77％）使用口服抗糖尿病药作为治疗方式。平均血红蛋白A1c水平为7.3％，平均PSQI为5.9。在调整了临床和人口统计学因素后，发现不良的睡眠状况与较高的A1c水平显着相关（p <0.05）。对于2期研究，招募了60名合格受试者。在完成磁性颗粒和精液的耳穴治疗后，立即发现CPSQI评分有显着改善。治疗3个月后仍保持阳性效果。至于HbA1c，研究仅表明治疗后血红蛋白的减少趋势不明显。除了治疗效果外，受试者还接受了诱导睡眠的耳穴疗法，没有出现严重的不良反应和抱怨。此外，耳蜗疗法是一种简单且不费时的方法。该研究对生活方式因素，尤其是睡眠质量，对中国2型糖尿病患者的疾病控制具有重要的了解。使用中药（TCM）方法，例如著名的耳穴疗法，是改善糖尿病患者睡眠状况的补充干预措施。这种干预对他们的血糖控制也有有益的作用。这项可行性研究的结果表明，耳涂疗法对于患者和护理实践环境都是安全且适当的临床实践。这些发现还暗示有理由在一项具有足够功效的研究中对诱导睡眠的耳穴疗法对血糖控制的效果进行更严格的评估。

著录项

  • 作者

    Kwan, Yee Mei.;

  • 作者单位

    The Chinese University of Hong Kong (Hong Kong).;

  • 授予单位 The Chinese University of Hong Kong (Hong Kong).;
  • 学科 Health Sciences Nursing.
  • 学位 D.Nursing
  • 年度 2013
  • 页码 205 p.
  • 总页数 205
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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