Educational Program Interventions for Patients Suffering From Persistent Pelvic Pain and Their Effects Over Pain and Functionality. A Multi-centered Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
Patients suffering pelvic persistent pain deal with significant pain that affects their quality of life. Often, conservative treatment interventions are scarce for these patients and are therefore not considered. Education has been developed as a relevant tool in the treatment of patients who suffer from chronic pain or any other pain processing alterations, and has the potential to become a powerfull treatment alternative.
详细描述
In this intervention, the effects of implementing educational programs in patients suffering from pelvic persistent pain will be assessed.
Patients with pelvic persistent pain have both problems directly related with their pain and other issues that appear derived from suffering pain over a determined period, such as alterations in the sexuality or overall quality of life. Facing these patients is a challenge for professionals, and many can't find the treatment that properly fits the patient's clinical presentation.
Education, and educating patients on their problem, is an exponentially growing alternative used in Physical Therapy involving patients who suffer from a dysfunctional pain, chronic pain, or any kind of pain presentation that affects the patient's well-being.
This study will assess firstly if the implementation of a pain-related education program is relevant in the treatment of pelvic persistent pain, and will further observe which modality (presential workshops or online-accessed material) is the most effective involving adherence and improvement.
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 (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Due to the nature of the intervention, participants can't be blinded to allocation, but are strongly inculcated not to disclose the allocation their status at the follow up assessments. Care providers will be different from outcome assessors and will be both blinded by an external investigator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years-old suffering from dyspareunia for more than 3 months
排除标准
- •Patients suffering from a previous medical condition that explains logically the presence of pain
研究组 & 干预措施
Workshops
This group will attend face-to-face workshops were the educational program will be developed. These workshops will be available in several sites, and specific care providers will be assigned for each of these sites.
干预措施: Workshops (Other)
Online-accessed material
This group will be granted online access to a platform were the educational program will be uploaded. They will be given autonomy regarding when to enter the platform and view the content.
干预措施: Online-accessed material (Other)
Control group
This group will initially no recieve an intervention and will serve as a control group.
结局指标
主要结局
Visual Analogue Scale
时间窗: Baseline to week 4
Pain intensity assessment instrument. Minimum value 0, maximum value 10. Higher scores mean worse outcome
次要结局
- Pain Catastrophizing Scale(Baseline to week 4)
- Female Sexual Function Index(Baseline to week 4)
- Survey of Pain Attitudes(Baseline to week 4)
研究者
Borja Pérez-Domínguez
Associate Professor
University of Valencia