Effects of a Web-based Therapeutic Educational Intervention About Pain and Poor Sleep Quality in Women Diagnosed With Fibromyalgia: a Mixed Methods Research With Sequential Exploratory Design
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pain Intensity
研究概览
简要总结
Fibromyalgia is the most common central sensitivity syndrome and one of the principal causes of chronic widespread pain among the adult population worldwide. Recent studies indicated that poor sleep quality is highly prevalent and a troublesome symptom among patients with fibromyalgia. Psychosocial and behavioral factors have been demonstrated to be intimately related with the symptomatic experience of fibromyalgia patients. Pain catastrophizing and dysfunctional beliefs and attitudes about sleep are involved in the perpetuation of those symptoms and affecting other spheres of the syndrome Objective: The aim of this project is to evaluate the cognitive and behavioral factors related with pain and poor sleep quality in women diagnosed with fibromyalgia so as to develop and test the effects of a web-based therapeutic educational intervention about pain and sleep on pain intensity, pain catastrophizing, sleep quality, dysfunctional beliefs and attitudes about sleep, and quality of life and health status related with fibromyalgia Methods: A mixed methods research with sequential exploratory design will be applied. For the qualitative phase, a snowballing sampling technique will be used. The participants will be invited to participate in a personal semi-structured interview. For the quantitative phase a sample of 64 adult women with fibromyalgia will be recruited from primary care centers of the city of Lleida and randomized into either the intervention or the control group Discussion: There is an imperative necessity of taking patients' symptoms experience as essential for the development of effective symptom management strategies from a biopsychosocial perspective. In the era of the internet, our web-based therapeutic educational intervention could open a new window for the treatment of women with fibromyalgia as part of current FM management treatments in primary care.
Our hypotheses are:
- Cognitive and behavioral factors related to pain and poor sleep quality in women diagnosed with fibromyalgia act as perpetuating factors and aggravate the general health status and the quality of life of these patients.
- A web-based therapeutic educational intervention about pain and poor sleep quality in women diagnosed with FM is better than the conventional approach for the treatment of pain intensity, pain catastrophizing, sleep quality, dysfunctional beliefs and attitudes about sleep, and general health status and quality of life-related with FM.
详细描述
Study design Mixed method research with a sequential exploratory design.
A three-stage procedure will be used:
- Qualitative phase: collection and analysis of qualitative data.
- Connection phase: based on the results obtained in the previous stage the content of the educational intervention will be developed.
- Quantitative phase: the resulting educational intervention will be tested in a sample of the target population and subsequently the quantitative data will be collected and analyzed.
Qualitative Phase Objective To explore the evaluation (cognitive factors) and response (behavioral factors) associated with pain and poor sleep quality in Spanish women diagnosed with Fibromyalgia.
Methodological orientation and Theory Generic qualitative study Sampling, Sample Size, and Method of Approach In this phase, a non-probabilistic snowball sampling technique will be used. The inclusion of participants will stop when new ideas or data about the research topic stop appearing, that is, until the information is saturated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
the participants and the study researchers will not know the group assigned to each subject. In fact, the evaluations will be carried out through the website.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Fibromyalgia based on the 2016 criteria of the American College of Rheumatology
- •Women in adulthood: between 18 and 65 years of age
- •Understand and speak Spanish and/or Catalan
- •Accept and sign the informed consent
排除标准
- •Be receiving or having received interventions similar to this study
结局指标
主要结局
Pain Intensity
时间窗: 4 weeks
Visual Analogue Scale: It was developed in the second half of the seventies and is considered the most sensitive test for the measurement of pain intensity. It is a user-friendly tool which consists of a numerically graduated line from 0-100, with 0 "no pain" and 100 "unbearable pain". Based on the research of Dworkin et al. it is established that a decrease of between 10 and 20% of pain intensity as the minimum clinically important difference, a change of ≥30% as a moderate clinical difference and, finally, a reduction in pain intensity ≥ 50% reflects substantial changes.
次要结局
- Pain Catastrophizing(4 weeks)
- Health status and quality of life associated with fibromyalgia(4 weeks)
- Sleep quality(4 weeks)
- Dysfunctional Beliefs and Attitudes about Sleep(4 weeks)
研究者
Carolina Climent-Sanz
Pre-doctoral fellow
Universitat de Lleida