Hess Engström Andrea Hess, Kullinger Merit, Jawad Izabella, Hesselman Susanne, Buhrman Monica, Högberg Ulf, Skalkidou Alkistis
Centre for Clinical Research, Västmanland County Hospital, Västerås, Sweden.
Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
Internet Interv. 2021 Apr 20;25:100396. doi: 10.1016/j.invent.2021.100396. eCollection 2021 Sep.
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.
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.
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.
NCT02809612.
外阴痛被定义为持续至少3个月且无明确病因的外阴疼痛。据我们所知，尚无试验研究使用包含接纳与承诺疗法（ACT）成分的认知行为疗法（CBT）进行网络治疗对患有外阴痛的女性的效果。本研究的目的是检验这种基于网络的引导式干预在临床治疗等待期对诱发性外阴疼痛的影响。
我们将把52名患者随机分为两组，一组在等待常规治疗期间接受包含ACT成分的基于网络的引导式CBT干预，另一组不接受干预。在基线、治疗后以及9个月后的随访时进行在线评估。主要结局指标是诱发性外阴疼痛。次要结局指标包括抑郁、焦虑、性功能和生活质量。将使用线性混合效应模型，通过意向性分析方法评估基于网络的干预随着时间推移对外阴疼痛、疼痛接纳、抑郁、焦虑、性功能和生活质量的影响。连续数据将使用一般线性模型，采用意向性分析和符合方案分析方法来评估干预在不同时间点的效果。有序数据和二元数据将分别使用曼-惠特尼检验、费舍尔精确检验和多变量逻辑回归进行分析。
作为一项具有短期和长期随访点的随机对照试验，EMBLA研究旨在对外阴痛的治疗以及基于网络的治疗作为外阴痛女性标准护理补充的作用提供新的、更好的理解。研究了外阴痛对疼痛、性功能、生活质量、抑郁和焦虑的影响。预计该研究结果在医疗领域临床护理规划中具有价值。在类似研究中，高辍学率和与使用该平台相关的技术困难很常见。
NCT02809612。
