The Effect of Reflexology Massage Applied to Diabetic Neuropathic Pain on Patients Quality of Life
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- life quality
研究概览
简要总结
Reflexology massage, applied by applying pressure to any point on the feet, is one of the most popular complementary treatments in the world. Given the negative impact of neuropathic pain on quality of life and the limited effectiveness of traditional medicines, it is important to investigate the effects of various complementary therapies available, including reflexology massage. Therefore, the study was planned as a prospective randomized controlled experimental study with a pre-test and post-test design aiming to investigate the effect of reflexology massage for neuropathic pain on pain intensity and quality of life in diabetic individuals.
详细描述
Pressure will be applied to the relevant reflex areas of the foot based on the individual's pain area. In order to standardize the application, the procedure will start with the left foot and end with the right foot. Both feet will be massaged using petroleum jelly for 5 minutes of relaxation movements, 5 minutes of general foot massage and 5 minutes of standing and reflex area corresponding to the painful body area. 5 more minutes will be applied to the left foot in order to increase the endorphin secretion and reduce the pain by activating the parasympathetic system. Reflexology massage will be applied for a total of 35 minutes in one session. Each reflexology area will be stimulated 15 times, as less than 10 stimulation to a particular reflexology area does not produce any therapeutic effect and more than 20 stimulations will be excessive. A total of 3 follow-ups will be done throughout the study. In the follow-up sessions; Visual Analogue Scale (VAS), Douleur Neuropathique 4 (DN4), The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) , Neuropathic Pain Impact on Quality-of-Life questionnaire (NePIQoL) scales will be applied, foot assessment and SWMI test will be applied. The 1st follow-up will be done before any intervention in the 1st session, the 2nd follow-up will be done after the reflexology application in the 5th session, and the 3rd follow-up will be done after the reflexology application at the 10th session . There will be a break of at least one day between two sessions to relax the body and eliminate toxins.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those over the age of 18,
- •Literate,
- •A diagnosis of neuropathic pain associated with Type 2 diabetes,
- •Defined pain of at least 4 severity according to the Visual Analogue Scale (VAS),
排除标准
- •A diagnosis of disease causing neuropathy (uremia, malnutrition, liver failure, alcoholism, kidney failure, dialysis treatment, oncology patients, vitamin deficiency),
- •have a pacemaker,
- •Diabetic foot diagnosis,
- •who are pregnant,
- •Having vision, hearing, cognitive ability disorders and psychosis, Reflexology massage in the last month,
- •Receiving medical treatment with an effect that conceals neuropathic pain symptoms,
- •Disc herniation,
- •Any infectious skin disease (shingles, fungus, etc.),
- •Individuals with open lesions / wounds, scar tissue, fractures, dislocations, amputation, edema, hematoma, thrombophlebitis, inflamed and degenerative joint diseases in the lower extremities will not be included in the sample.
结局指标
主要结局
life quality
时间窗: 5 Months
Change of quality of life score higher than 42 points according to the Neuropathic Pain Impact on Quality-of Life Questionnaire (NePIQoL) scale
pain intensity
时间窗: 5 Months
According to the Douleur Neuropathique 4 Questions (DN4) questionnaire, neuropathic pain score changes to less than 4 points.
次要结局
未报告次要终点
研究者
Nesibe Simsekoglu
Principal Investigator
Istanbul Saglik Bilimleri University