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Virtual Reality: Influence on Satisfaction, Pain, and Anxiety in Patients Undergoing Colposcopy

NCT04751799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2024-04-26

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Virtual reality headset before colposcopy

Patients wear a virtual headset presenting 360° 3D views of relaxing environments

DEVICE

Virtual reality headset during colposcopy

Patients wear a virtual headset presenting 360° 3D views of distracting environments

Sponsors & Collaborators

  • Ruhr University of Bochum

    lead OTHER

Principal Investigators

  • Clemens B Tempfer, MD · Ruhr-Universität Bochum / Marien Hospital Herne

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2022-07-07
Completion
2022-07-10

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04751799 on ClinicalTrials.gov