The Effect of Neuropathic Pain on Self-Care Ability and Quality of Life in Type II Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Neuropathic pain
研究概览
简要总结
Diabetes Mellitus (DM) is a common metabolic disease characterized by hyperglycemia resulting from insufficiency, deficiency or absence of the insulin hormone. Chronic hyperglycemia, secondary metabolic and microvascular changes resulting in diabetic neuropathy are among the most common complications encountered in DM patients.
Diabetic neuropathy is called peripheral, autonomic or spinal depending on the region of involvement. Peripheral involvement is more common than other region involvement and its prevalence in DM patients is observed to be 16-87%. Diabetic peripheral neuropathy (DPN) presents with numbness, tingling, paresthesia, muscle weakness and pain. These symptoms can start from the toes and progress to the leg and even the upper extremities.
In diabetic peripheral neuropathy, pain is seen as burning, electric shock or sharp cold pain, increases at night and affects sleep quality. In these patients, daily living activities such as walking, climbing stairs, and sleeping are negatively affected by progressive DPN and pain, falls are observed, mood disorders are experienced, and the quality of life decreases.
详细描述
In the study, the Data Descriptive Characteristics Form, Diabetes Quality of Life Scale, Self-Care Efficacy Scale, Neuropathic Symptoms and Signs Self-Assessment Scale and Visual Analog Scale will be used. Data will be collected using face-to-face interview technique with patients who apply to the Internal Medicine Outpatient Clinic and are diagnosed with Type II Diabetes. The researchers will conduct the data collection process between 09:00-16:00 on weekdays. After the patients are informed about the research, their informed consent will be obtained and they will be included in the study.
The Descriptive Characteristics Form was developed by the researchers by reviewing the relevant literature. It consists of 17 questions including information such as age, gender, chronic diseases, and medications used.
The original version of the Diabetes Quality of Life Scale, Diabetes Quality of Life (DQOL) scale was developed in 1988 by the Diabetes Control and Complications Study group.The Turkish culturally compatible version of the DQOL scale consists of four sub-dimensions and a total of 45 questions. The Cronbach α coefficient of the Turkish version of the DQOL scale translated by Yıldırım is 0.89.
Self-Care Agency Scale: The Self-Care Agency Scale was developed in 1979 and was adapted to Turkish in the Republic of Turkey and its validity and reliability were performed. The scale, which focuses on individuals' self-assessment of their involvement in self-care actions, consists of 35 items. The Cronbach Alpha Internal Consistency Coefficient of the scale was found to be 0.89.
VAS-Visual Analog Scale It is a scale divided into equal distances on a 10 cm horizontal plane with no pain on one side and "unbearable" pain on the other side. The patient is asked to mark the point on this line that best expresses the intensity of his/her pain. This distance, measured in millimeters, is interpreted as a "score". For pain intensity, 0 points are evaluated as "no pain" and 10 points as "the worst unbearable pain".
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older,
- •Diagnosed with type II diabetes,
- •Reading and writing,
- •No physical or psychological communication barriers,
- •Can read and speak Turkish,
- •Volunteers
排除标准
- •Diagnosed with type I diabetes
结局指标
主要结局
Neuropathic pain
时间窗: 15/12/2024-30/07/2025
Self-Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS) will be used to assess neuropathic pain types. When the score obtained from this scale consisting of 7 items is \>12, neuropathic pain is diagnosed.
the pain severity
时间窗: 15/12/2024-30/07/2025
As the first outcome of the study, the patients' neuropathic pain status and pain intensity will be determined. The following scales will be used for this. VAS-Visual Analog Scale will be used to assess pain. Scoring will be between 0-10.
次要结局
- Quality of life will be measured with the Diabetes Quality of Life (DQOL) scale(15/12/2024-30/07/2025)
- the Self-Care Agency Scale(15/12/2024-30/07/2025)