Clinical trials

After screening (including parts of the Mini-DIPS), participants will receive a pre-assessment with a baseline heartrate measurement, self-report measures and two BATs (with the treated spider and the non-treated spider). All participants receive a brief psychoeducation \& video demonstration of exposure steps. Participants are randomly assigned to the three study arms and are then set to receive a single session of either in vivo exposure (IVET), videochat based vicarious exposure (VicET) or neither (Waiting List Control, WLC). Approximately 24 hours later, the two BATs with both spiders, a slightly reduced set of self-report measures and an interview will conduct the post-assessment. The order of all BATs, the spider individuals (treated vs. non-treated spider) and assignment to study arms will be randomized using a list that will be worked through in a sequence determined using "www.random.org". At a six-week follow-up, another long-term assessment will be conducted. Here, participants will receive a brief online questionnaire related to their experiences with spiders and self-report measures that were previously administered. Participants previously assigned to the waiting list control (WLC) will be invited to participate in an in-vivo exposure session. A set of questionnaires including demographic information, VAS scales on the current psychological state and wellbeing (administered at the start and end of the first and second assessment day), the BDI-II, the STAI-T and STAI-S, FEE, SPQ, SBQ, FSQ, GSE, SEQ-SP, TC/E for treatment credibility and the "positive attitudes towards technology subscale" of the MTUA will be used. BDI-II, STAI and MTUA are only administered at pre-assessment. The SAS is used for initial screening.

Cervical cancer is one of the most common cancers in women and one of the leading causes of death in women worldwide. Pre-cancerous lesions (dysplasias) are detected by the preventive smear test at the gynecologist and can thus contribute to a 100% chance of cure if they are clarified by a colposcopic examination as part of the dysplasia consultation and dysplastic lesions are then surgically removed if necessary (conization). There are few data in the literature on the influence of the menstrual cycle on the bleeding pattern during and after conization. Hormonal variations during the menstrual cycle affect both the extent of blood flow to reproductive organs and hemostasis. In the follicular phase, there is a decrease in local blood flow in the uterus and pelvic organs and an increase in coagulability. Conversely, in the luteal phase there is an increase in local blood supply and a decrease in coagulability. Therefore, it seems reasonable to perform conization in the follicular phase to possibly reduce the extent and incidence of bleeding and bleeding complications. This assumption is supported by clinical observations. For example, there is evidence from other specialties that selection of the timing of surgery, taking into account the menstrual phase, may influence the risk of bleeding. Another factor of interest in menstruation-based surgical planning is psychological vulnerability, which may also vary with the menstrual cycle. Until now, consideration of the menstrual cycle in surgical planning for conization has not been standard practice and there is no recommendation in this regard in the current S3 guideline of the German Society of Gynecology and Obstetrics. Therefore, this study now aims to answer the question under prospective randomized conditions whether LLETZ conization performed during the follicular phase results in lower blood loss and higher patient satisfaction and lower anxiety scores compared to LLETZ conization performed during the luteal phase.

Cervical dysplasia is the precursor of cervical cancer. LEEP and LLETZ are standard surgical procedures to treat cervical dysplasia. There is no direct head-to-head comparison between LEEP and LLETZ in the literature regarding oncologic safety, for which complete resection of the dysplastic lesion (so-called 'in-sano resection') is the most appropriate postoperative surrogate parameter. Further clinical studies are therefore useful to optimize surgical therapy for cervical dysplasia. The primary objective of the present study is to compare LLETZ (resection of the dysplastic lesion including the transformation zone) with targeted resection of the colposcopically conspicuous lesion only (LEEP) and to compare it with regard to oncological safety (defined as non-in-sano rate).