Kaarbø Mette Bøymo, Danielsen Kristine Grimen, Haugstad Gro Killi, Helgesen Anne Lise Ording, Wojniusz Slawomir
Faculty of Health Sciences, Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway.
Unit for Psychosomatics/CL Outpatient Clinic for Adults, Acute Psychiatric Department, Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway.
Pilot Feasibility Stud. 2022 Mar 23;8(1):68. doi: 10.1186/s40814-022-01022-2.
Provoked vestibulodynia (PVD) is a prevalent chronic pain condition especially among young women. Pain is localized to the vulvar vestibule and is provoked by touch or pressure, such as penetrative intercourse. PVD can have profound consequences, adversely affecting a woman's sexual life, relation to her partner, and her psychological health. There is an urgent need for well-designed randomized clinical trials (RCTs) to identify the most effective interventions for this neglected women's health condition.
The primary aim of this study is to assess the feasibility of undertaking a full-scale RCT of somatocognitive therapy (SCT), a multimodal physiotherapy intervention, for women with PVD. The secondary aim is to evaluate the implementation and acceptability of SCT and its potential treatment effectiveness in PVD. In the full-scale RCT, SCT will be compared to standard PVD treatment.
A multimethod feasibility study with a single-arm before-after trial and qualitative interviews. Ten women with PVD, aged 18-33 were recruited from the Vulva Clinic at Oslo University Hospital. The intervention took place at Oslo Metropolitan University. Participants were assessed at baseline, post-treatment, and the 8-month follow-up with the tampon test and self-report questionnaires. The main feasibility outcomes were evaluation of recruitment rate, adherence to assessment tools, and follow-up rate. The participants' experiences with the primary outcome and the intervention were explored with semi-structured interviews.
Ten out of 18 eligible patients were recruited over 11 weeks. None were lost to follow-up. Adherence to self-report questionnaires was excellent. Adherence to tampon tests and to the reporting of treatments was good, whereas adherence to the 14-day diary was poor. No adverse events were reported. The tampon test was suboptimal as a primary outcome. SCT was found to be an acceptable treatment, based on Global Perceived Effect scores and the participants' experiences.
The findings suggest that it is feasible to deliver a full-scale RCT of the SCT intervention for women with PVD. Some changes are suggested to optimize the protocol, such as increasing recruitment sites, change of primary outcome measures, and adding a booster session.
ClinicalTrials.gov NCT04208204 . Retrospectively registered on December 23, 2019.
诱发性前庭痛（PVD）是一种常见的慢性疼痛病症，在年轻女性中尤为普遍。疼痛局限于外阴前庭，可由触摸或压力引发，如性交时。PVD可能产生深远影响，对女性的性生活、与伴侣的关系以及心理健康产生不利影响。迫切需要设计完善的随机临床试验（RCT）来确定针对这种被忽视的女性健康状况的最有效干预措施。
本研究的主要目的是评估对PVD女性进行全面的体认知疗法（SCT，一种多模式物理治疗干预）随机对照试验的可行性。次要目的是评估SCT的实施情况、可接受性及其对PVD的潜在治疗效果。在全面的随机对照试验中，将SCT与标准的PVD治疗进行比较。
采用单臂前后试验和定性访谈的多方法可行性研究。从奥斯陆大学医院外阴诊所招募了10名年龄在18 - 33岁的PVD女性。干预在奥斯陆城市大学进行。在基线、治疗后以及8个月随访时，通过棉塞试验和自我报告问卷对参与者进行评估。主要的可行性结果是评估招募率、对评估工具的依从性和随访率。通过半结构化访谈探讨参与者对主要结局和干预措施的体验。
在11周内从18名符合条件的患者中招募了10名。无人失访。对自我报告问卷的依从性极佳。对棉塞试验和治疗报告的依从性良好，而对14天日记的依从性较差。未报告不良事件。棉塞试验作为主要结局并不理想。根据总体感知效应评分和参与者的体验，发现SCT是一种可接受的治疗方法。
研究结果表明，对PVD女性进行SCT干预的全面随机对照试验是可行的。建议进行一些改变以优化方案，如增加招募地点、改变主要结局指标并增加一次强化治疗。
ClinicalTrials.gov NCT04208204。于2019年12月23日进行回顾性注册。
