Background

Vulvodynia is defined as vulvar pain for at least 3 months without a clear cause. To the best of our knowledge, there are no trials investigating the effects of internet treatment using CBT (Cognitive behavioural therapy) treatment with Acceptance and Commitment Therapy (ACT) components for women with vulvodynia. The aim of this study is to examine the effects of such a guided internet-based intervention on provoked vulvar pain during the waiting period before clinical treatment.

Methods

We will randomise 52 patients to either guided internet-based intervention with CBT with (ACT) components or no intervention during the waiting period for treatment as usual. Online assessments are conducted at baseline, posttreatment, and at follow-up after 9 months. The primary outcome measure is provoked vulvar pain. Secondary outcomes are depression, anxiety, sexual function, and quality of life. Linear-mixed effect models will be used to assess the effect of the internet-based intervention on vulvar pain, pain acceptance, depression, anxiety, sexual function, and quality of life over time, by applying the intention-to-treat approach. Continuous data will be analysed with general linear models using intention-to-treat and also per protocol approaches to assess the effects of the intervention at different time points. Ordinal and binary data will be analysed with Mann Whitney's test, Fischer's exact test and multivariate logistic regression, respectively.

Discussion

As a randomised controlled trial with short- and long-term follow-up points, the EMBLA study intends to provide a novel and better understanding regarding the treatment of vulvodynia and the role of internet-based treatment as a complement to standard care for women suffering from vulvodynia. The effects of vulvodynia on pain, sexual function, quality of life, depression, and anxiety are investigated. The study's results are expected to be of value in the planning of clinical care in the medical area. High dropout rates and technical difficulties associated with using the platform are common in similar studies.

Trial registration number

NCT02809612

中文翻译：

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基于互联网的外阴痛治疗 (EMBLA) – 随机对照研究的研究方案

背景

外阴痛被定义为至少 3 个月没有明确原因的外阴疼痛。据我们所知，没有试验调查使用 CBT（认知行为疗法）和接受和承诺疗法 (ACT) 组件对患有外阴痛的女性进行互联网治疗的效果。本研究的目的是检查这种基于互联网的指导干预对临床治疗前等待期间诱发的外阴疼痛的影响。

方法

我们将随机安排 52 名患者接受基于互联网的引导式干预，使用带有 (ACT) 成分的 CBT 进行干预，或者在等待治疗期间像往常一样不进行干预。在基线、治疗后和 9 个月后的随访中进行在线评估。主要结果测量是诱发外阴疼痛。次要结果是抑郁、焦虑、性功能和生活质量。线性混合效应模型将通过应用意向治疗方法，用于评估基于互联网的干预对外阴疼痛、疼痛接受、抑郁、焦虑、性功能和生活质量的影响。连续数据将使用意向治疗的一般线性模型进行分析，并根据方案方法评估不同时间点的干预效果。

讨论

作为一项具有短期和长期随访点的随机对照试验，EMBLA 研究旨在就外阴痛的治疗以及基于互联网的治疗作为对受苦女性标准护理的补充的作用提供一个新的和更好的理解。从外阴痛。研究了外阴痛对疼痛、性功能、生活质量、抑郁和焦虑的影响。该研究的结果有望在医疗领域的临床护理规划中具有价值。与使用该平台相关的高辍学率和技术困难在类似研究中很常见。

试用注册号

NCT02809612