Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04751799 |
| Other study ID # |
VR-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 25, 2021 |
| Est. completion date |
July 10, 2022 |
Study information
| Verified date |
April 2024 |
| Source |
Ruhr University of Bochum |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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
Dysplasia of the cervix typically becomes conspicuous during the gynecological screening
examination at the gynecologist. In this case, smears are taken from the ectocervix and
endocervix and assessed by the cytologist after a Papanicolaou stain has been performed with
regard to dysplastic cells and the quality of the smear. For further clarification of
dysplastic changes, presentation to a specialized dysplasia consultation is recommended.
During colposcopic examination, histological confirmation of dysplastic areas is performed by
means of biopsy.
Colposcopy (visual examination of the vagina and the entrance to the uterus with optical
magnification) is an integral part of early cervical cancer detection. It is used to
visualize dysplastic areas on the cervix uteri and to determine their spatial expression. The
magnifying glass allows a multilevel (3.5 to 30x) two-dimensional magnification. After visual
identification of suspicious areas using 5% acetic acid (dysplasias become acetic white) and
classification into "minor" (grade 1) or "major" (grade 2) changes according to the
internationally used RIO classification, a targeted biopsy for exact determination of the
degree of dysplasia is possible [4]. Only in this way is further individual therapy planning
possible.
Pain sensation during colposcopic examination.
Colposcopy itself and especially colposcopic targeted biopsy of the cervix are painful [4,
5]. General practice is to use local analgesics, oral analgesics, or no analgesics during a
colposcopically targeted biopsy of the cervix [5]. The use of nonpharmacologic methods to
positively influence patient pain perception and satisfaction has been investigated in a
number of studies. For example, in a prospective randomized study, our group demonstrated
that classical music (Mozart, Symphony No. 40 in G minor, KV 550) [6] had no positive
influence on satisfaction and pain perception. Similarly, in another randomized study, we
found no positive influence on satisfaction and pain perception by using video colposcopy
[7]. 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 effect on the
course of medical interventions. For example, in a systematic review and meta-analysis of 8
randomized trials with a total of 723 subjects, Ding et al showed lower postoperative pain
scores after the application of VR in the context of various surgeries such as dental, knee,
hemorrhoid surgery, and obstetric injury care [8].
Randomized trials of the effectiveness of VR in a collective of women undergoing
colposcopy-targeted cervical biopsy are not available according to a recent literature search
(PubMed search as 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 [7, 9].
Therefore, a controlled study on the effectiveness of VR in colposcopy-targeted biopsy is
reasonable.
Aim of the study
Our study now aims to answer the question under prospective conditions whether the use of VR
before initiation or before initiation 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.
References
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3. Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer
statistics, 2012. CA Cancer J Clin. 2015;65:87-108. doi:10.3322/caac.21262.
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doi:10.1007/s00292-011-1480-9.
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Theoretische Grundlagen und Handlungsanweisungen. Weinheim: Beltz; 1981.
11. Bornstein J, Bentley J, Bösze P, Girardi F, Haefner H, Menton M, et al. 2011 colposcopic
terminology of the International Federation for Cervical Pathology and Colposcopy.
Obstet Gynecol. 2012;120:166-72. doi:10.1097/AOG.0b013e318254f90c.
12. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data
capture (REDCap)--a metadata-driven methodology and workflow process for providing
translational research informatics support. J Biomed Inform. 2009;42:377-81.
doi:10.1016/j.jbi.2008.08.010.
