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临床试验/NCT05114317
NCT05114317Unknown不适用

Pain Characteristics, Intensity, Patterns, Impact and Quality of Life in Women With Lipoedema: an Online Survey

Glasgow Caledonian University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Brief Pain Inventory - short form

研究概览

简要总结

This observational study will seek to investigate the following questions in women with lipoedema:

  • pain characteristics, intensity and patterns of pain
  • the relationships between the characteristics, intensity and patterns of pain and age, ethnicity, location, employment status, levels of anxiety/depression, walking ability, ability to work, relations with other people, impact on sleep and quality of life.
  • the impact of pain treatments or medications on the intensity of pain. The information will be collected via an online survey and participants will be recruited through social media platforms.

详细描述

Lipoedema is a chronic adipose tissue disorder that occurs almost exclusively in women and affects approximately 11% worldwide. Pain is a recurring feature described by people with lipoedema (pwL) with a recent study reporting 88.3% of patients indicating pain as a clinical feature. It has been suggested, with chronic long-term conditions, that the pain people experience can be moulded by a myriad of elements.This includes biomedical, psychosocial (e.g. patients' beliefs, expectations, and mood), and behavioural factors (e.g. context, responses by significant others). PwL often experience significant impairment in their daily activities and quality of life. It has further been found that psychological and the biomedical consequences of lipoedema can increase the chances of anxiety and depression which can subsequently further impact on quality of life and pain experience.

This observational study will seek to investigate the following questions in women with lipoedema:

  • pain characteristics, intensity and patterns of pain
  • the relationships between the characteristics, intensity and patterns of pain and age, ethnicity, location, employment status, levels of anxiety/depression, walking ability, ability to work, relations with other people, impact on sleep and quality of life.
  • the impact of pain treatments or medications on the intensity of pain. INformation about pain characteristics, demographics, mood, functional ability and quality of life will be collected via an online survey and participants will be recruited through social media platforms.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with lipoedema
  • 16 years and older

排除标准

  • Inability to provide consent

结局指标

主要结局

Brief Pain Inventory - short form

时间窗: Only once at participation, the study duration is approximately 2 years

The Brief Pain Inventory - Short Form is a simple, 9 question self-reporting tool that expands on other questionnaires such as the McGill pain questionnaire which focuses more on the quality of pain. The questionnaire allows the individual to rate the severity of pain and it also looks at how pain affects daily functions and discloses the site of pain in the past 24 hours. Within the questionnaire there are four severity questions looking at pain 'at least', 'at worst' (both in the last 24 hours), 'on average' and 'now' using a Likert scale with 0 = no pain to 10 = pain as bad as you can imagine. Seven pain interference domains are also included in the questionnaire covering general activity, mood, walking ability, normal work, relations with others, sleep and enjoyment of life. These are also measured on a Likert scale with 0 = no interference to 10 = interferes completely.

次要结局

  • Depression, Anxiety and Stress Scale - 21(Only once at participation, the study duration is approximately 2 years)
  • World Health Organization Quality of Life Assessment(Only once at participation, the study duration is approximately 2 years)
  • Symptoms severity scale(During study, only once at participation - 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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