Progressive Muscle Relaxation and Mindfulness Meditation on Neuropathic Pain, Fatigue and Quality of Life in Type 2 Diabetes Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Change in pain severity
研究概览
简要总结
Patients with painful diabethic peripheral neuropathy will be entered.. Participants will be randomized to one of three study arms: Arm 1: relaxatio; Arm 2:meditation Arm 3: Attention matched control Hypothesis: Progressive muscle relaxation and mindfullness meditation will decrease severity of neuropathc pain and fatigue and improve quality of life.
详细描述
Previous reports have revealed that progressive muscle relaxation and meditation are promising for glycemic control in type 2 diabetes patients. On the other hand, research examining effects of these approaches on painful diabetic peripheral neuropathy, fatigue and quality of life is limited. The present study investigates the effects of progressive muscle relaxation and mindfullness meditation in a single-site, 3-arm, assessor blinded randomized, controlled study of 77 type 2 diabetes patients with painful diabetic peripheral neuropathy. Arm 1: relaxation; Arm 2: mindfulness meditation; Arm 3: Attention matched control. The investigators hypothesize that Progressive muscle relaxation and mindfulness meditation will decrease severity of neuropathic pain and fatigue and improve quality of life.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being diagnosed with painful diabethic peripheral neuropathy ,
- •being at least primary school graduates,
- •not using any other complementary or integrative therapy during the study period
排除标准
- •neuropathy history due to any other causes such as megaloblastic anemia, fibromyalgia, autoimmune diseases, hypothyroidism, and lumbar disc hernia
- •having end-stage of renal failure, chronic obstructive pulmonary disease, advanced cardiac failure, musculoskeletal disorders or depression
- •having a diabetic foot ulcer or amputation.
结局指标
主要结局
Change in pain severity
时间窗: Baseline measurements, at the end of 12th week and two weeks after the completion of the interventions
Pain severity will be measured based on patient report by a visual analog scale. Higher score means increase in pain severity.
次要结局
- Change in Quality of life status(baseline measurements, at the end of 12th week and two weeks after the completion of the interventions)
- Change in fatigue severity(Baseline measurements, at the end of 12th week and two weeks after the completion of the interventions)
研究者
Nur Izgu
Assistant professor
Hacettepe University