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NCT04751799
Virtual Reality: Influence on Satisfaction, Pain, and Anxiety in Patients Undergoing Colposcopy
NA trial testing Virtual reality headset before colposcopy in Cervical Dysplasia in 247 participants. Completed in 10 July 2022.
7 July 2022
Quick facts
| Lead sponsor | Ruhr University of Bochum |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 247 |
| Start date | 25 May 2021 |
| Primary completion | 7 July 2022 |
| Estimated completion | 10 July 2022 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Virtual reality headset before colposcopy
- Virtual reality headset during colposcopy
Conditions studied
- Cervical Dysplasia — all drugs for Cervical Dysplasia →
- Pain — all drugs for Pain →
- Anxiety — all drugs for Anxiety →
Sponsor
Ruhr University of Bochum
Who can join
18 and older, female only, with Cervical Dysplasia or Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04751799
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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Other Ruhr University of Bochum trials
Trials by the same sponsor.
- NCT07432945 — In Vivo Exposure vs. Videochat-Based Vicarious Exposure · NA · recruiting
- NCT06255821 — The Effect of Time on Generalization of Exposure-based Benefit · NA · completed
- NCT05824884 — Self-efficacy Enhancement in a Virtual Reality Training for Fear of Heights · NA · recruiting
- NCT05798078 — The Relationship Between Social Anxiety and Anxious Thinking Styles · NA · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04751799 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ruhr University of Bochum
- Last refreshed: 26 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04751799.
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