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临床试验/NCT04751799
NCT04751799已完成不适用

Impact of a VR Headset on Pain Perception and Satisfaction During Colposcopic Workup of Cervical Precancerous Lesions: a Multicenter Randomized-controlled Trial.

Ruhr University of Bochum1 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2021年5月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
247
试验地点
1
主要终点
Patient satisfaction

研究概览

简要总结

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 screening smear test at the gynecologist's office and can thus contribute to a 100% chance of cure if they are clarified by a colposcopic examination as part of the dysplasia consultation.

To detect cervical dysplasia during colposcopic examination, the effect of diluted acetic acid on the epithelium of the cervix uteri is utilized. Metaplastic epithelium and low-grade dysplasia are visually noticeable by a slight white staining. Biopsies are then taken from these areas for further diagnosis.

The colposcopy itself and especially the colposcopic targeted biopsy of the cervix are painful. Virtual reality (VR) is a new method for 360° three-dimensional viewing of image content. A number of studies have shown that the use of VR can have a positive impact on the course of medical interventions. Randomized studies on the effectiveness of VR in a collective of women with colposcopically targeted biopsy of the cervix are not available according to a recent literature search (PubMed search of 12/30/2020; search terms: cervical biopsy, colposcopy, pain relief, pain control, virtual reality). In studies of our research group on colposcopy, we found increased pain scores especially in younger patients, but also in obese patients and smokers. A controlled study on the effectiveness of VR in colposcopically targeted biopsy is therefore useful.

In our study, we now want to answer the question under prospective conditions whether the use of VR before the start or before the start and during colposcopy compared to no intervention leads to a significant increase in patient satisfaction and/or a reduction in pain in the context of clarification colposcopy and colposcopically targeted biopsy.

详细描述

HPV and cervical cancer

Human papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide. The prevalence in the population is high. Epidemiological estimates suggest that 75-80% of sexually active adults acquire an HPV infection in the genital area at least once by the age of 50. However, up to 95% of these HPV infections are considered harmless and are spontaneously eliminated within 2 years in terms of immunological HPV clearance [1]. On the other hand, persistent infections with HPV of the high-risk group, e.g. HPV-16 and HPV-18, are the main cause for the development of cervical carcinoma and are also partly responsible for the development of vulvar carcinoma, vaginal carcinoma and anal carcinoma. HPV preferentially infects the epithelial cells of the anogenital region and, through incorporation of HPV DNA into the host genome and subsequent interference with the cell cycle control of the host cell, causes changes in the cervical epithelium that, if left untreated, may develop into precancerous lesions (so-called cervical intraepithelial neoplasia) and consecutively into invasive carcinoma of the cervix (cervical carcinoma). Specifically, the viral protooncogene E6 gene product couples to p53 and promotes its degradation, and the viral protooncogene E7 gene product forms a complex with the retinoblastoma gene product pRB and suppresses its tumor suppressor function [2]. Both the impairment of apoptosis and tumor suppressor function promote immortalization of infected basal cells in the transformation zone of the cervix uteri.

Cervical carcinoma is the third most common cancer in women worldwide, as well as the fourth leading cause of death in women worldwide. Cervical carcinoma accounted for 9% (n=529 800) of all new cancer cases and 8% (n=275 100) of cancer-related deaths in women in 2008 [3].

The precursor of cervical cancer is cervical intraepithelial neoplasia (CIN), which can lead to the development of squamous cell carcinoma (approximately 80% of all cervical cancers). Three grades of expression are distinguished in CIN (CIN1, CIN 2, and CIN 3). Compared with invasive cervical carcinoma, the occurrence of precancerous lesions of the cervix uteri is more widespread. It is estimated that approximately 100,000 women in Germany develop new dysplasias (CIN 1-3) annually, with a point prevalence of >200,000 [3, 4].

Colposcopy as a diagnostic method

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

No masking possible due to the nature of the intervention (using a virtual reality headset vs. not using a VR headset)

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

  • •Written consent to participate in the study
  • •Clinically indicated colposcopy in case of abnormal PAP smear for detection of precancerous lesions of the cervix uteri and/or clinical abnormality of the cervix uteri (e.g. leukoplakia) with biopsy

排除标准

  • •Eye diseases (e.g., glaucoma/cataracts) that impair viewing of VR content.
  • •Claustrophobia/agoraphobia or epilepsy
  • •Patients with insufficient knowledge of the German language

研究组 & 干预措施

Control Group (no VR)

No Intervention

Patients undergoing colposcopy and colposcopically-guided biopsy without further intervention

VR before and during colposcopy

Experimental

Patients undergoing colposcopy and colposcopically-guided biopsy with a VR headset for 15 minutes before colposcopy as well as during colposcopy.

干预措施: Virtual reality headset before colposcopy (Device)

VR before and during colposcopy

Experimental

Patients undergoing colposcopy and colposcopically-guided biopsy with a VR headset for 15 minutes before colposcopy as well as during colposcopy.

干预措施: Virtual reality headset during colposcopy (Device)

VR before colposcopy

Experimental

Patients undergoing colposcopy and colposcopically-guided biopsy with a VR headset for 15 minutes before colposcopy but not during colposcopy.

干预措施: Virtual reality headset before colposcopy (Device)

结局指标

主要结局

Patient satisfaction

时间窗: immediately after procedure

11-item VAS (0 = not satisfied at all, 10 = totally satisfied)

次要结局

  • Surgical complications(72 hours after colposcopy)
  • Patient pain(immediately after the colposcopy)
  • Patient anxiety(during the colposcopy)
  • Patient pain(during the colposcopy)

研究者

发起方
Ruhr University of Bochum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Günther Rezniczek

Principal Investigator

Ruhr University of Bochum

研究点 (1)

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