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Clinical Trials/NCT04751799
NCT04751799CompletedNot Applicable

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 site in 1 country247 target enrollmentStarted: May 25, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
247
Locations
1
Primary Endpoint
Patient satisfaction

Study Overview

Brief 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.

Detailed 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Masking Description

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

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: 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.

Intervention: 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.

Intervention: Virtual reality headset before colposcopy (Device)

Outcomes

Primary Outcomes

Patient satisfaction

Time Frame: immediately after procedure

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

Secondary Outcomes

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

Investigators

Sponsor
Ruhr University of Bochum
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Günther Rezniczek

Principal Investigator

Ruhr University of Bochum

Study Sites (1)

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