Pain in Patients With Chronic Leg and Foot Ulcers - a Cross Sectional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Pain intensity - Numeric Rating Scale (NRS)
研究概览
简要总结
Leg ulcers are a significant cause of impaired functional ability and quality of life for approximately 1-2 percent of the population in western countries. Although pain seems to be one of the most devastating aspects of living with a chronic ulcer, research is limited and there is a lack of knowledge about wound-related pain characteristics. Little is known about prevalence, pain intensity, qualities, location, temporal fluctuations, to witch degree pain impact on physical- and psychosocial functioning, as well as relieving and exacerbating factors.
The overall purpose of this study is to investigate the prevalence and characteristics of wound related pain in patients with chronic leg ulcers. More specific research questions are: 1) What is the prevalence and characteristics of wound related pain in patients suffering from various types of persistent ulcers, 2) How do patients with different ulcer diagnoses report the quality of the wound related pain, 3) Is there any differences in wound pain characteristics among patients with different etiology leg ulcers, 4) How is the pain temporal pattern in patients with chronic leg- and foot ulcers, 5) What is the reported quality of life in patients with different ulcer diagnosis, and 6) Is there any association among pain characteristics, sleep and quality of life in patients with chronic leg/foot ulcers? The study has a non-experimental, explorative and descriptive approach. A cross-sectional questionnaire design will be used to explore patient's experience of wound-related pain.
The patients will be recruited at the outpatient clinic appointment and home-care nursing in Norway. Participants will fill out self-report questionnaires. The battery of questionnaires will obtain information about demographic data, pain characteristics, quality of life and sleep. Pain characteristics, quality of life and sleep will be assessed by using different questionnaires that has demonstrated high validity and reliability. In addition, the temporal pattern of pain will be assessed by asking the participants to fill out a form stating subjective level of pain (NRS) every hour during a typical day, and to mark times that they rest and sleep. Relevant information about the diagnosis/classification of ulcer, comorbidities, the ulcer management and pain management will be collected in a clinical examination.
详细描述
Design: The study has a non-experimental, explorative and descriptive approach. A cross-sectional questionnaire design, that provides quantitative data, will be used to explore patient's experience of wound-related pain.
Recruitment: Patients will be recruited from outpatient clinics and home-care nursing in Norway. Written informed consent will be obtained from all eligible patients who agree to participate.
The patients will be recruited at the outpatient clinic appointment. Those willing to participate will complete the questionnaire independently and return the questionnaire by mail in a pre-paid envelope. Furthermore, relevant information about the diagnosis/classification of ulcer, comorbidities, the ulcer management and pain management will be collected in a clinical examination, and by talking to the participants. The clinical examination will take place in relation to already scheduled dressing-change, in order to minimize the burden of participating in the study.
Based on clinical experience, and expert opinion, the research group have reason to believe that the ulcers can be classified in three main categories; ulcers with venous insufficiency as main perpetuating factor, ulcers with arterial insufficiency as main perpetuating factor, and ulcers with diabetes as the main perpetuating factor.
This study will not look at the effect-size of an intervention, or test a hypothesis. Therefore, the sample size is calculated based on the need to carry out the planed regression analysis to look at predictors of quality of life for patient with different etiology leg ulcers. In this study, quality of life will be a dependent variable, whereas pain, sleep, age, gender, wound area and possibly social status will be independent variables.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Leg- or foot ulcer that has persisted for more than 6 weeks
排除标准
- •Psychological and cognitive restrictions that prohibit from providing informed consent, reading or writing disabilities
- •Inability to participate due to physical/psychological challenges, and inability to differentiate wound-related pain from other types of pain in the lower extremities.
- •The following ulcer-diagnosis will be excluded: Burn-ulcer, cancer-ulcer, radiation-ulcer, immunological ulcers and vasculitis ulcers.
结局指标
主要结局
Pain intensity - Numeric Rating Scale (NRS)
时间窗: Through study completion, an average of 3 years
One-dimensional measure of pain intensity.
次要结局
- Sleep assessment - The Insomnia Severity Index (ISI)(Through study completion, an average of 3 years)
- Quality of life - The EuroQol-5D (EQ-5D)(Through study completion, an average of 3 years)
- Quality of pain - The Short Form McGill Pain Questionnaire (SF-MPQ)(Through study completion, an average of 3 years)
- Brief Pain Inventory (BPI)(Through study completion, an average of 3 years)
- Localization of pain, Body map for localization of pain(Through study completion, an average of 3 years)
- Temporal pattern of pain(Through study completion, an average of 3 years)
- Variation of pain intensity throughout the day(Through study completion, an average of 3 years)