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

NCT04751799 | Completed

• 1 other identifier: VR-1
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Dysplasia; Pain; Anxiety

Keywords

colposcopy; virtual reality; cervical dysplasia; pain; anxiety

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

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

  immediately after procedure

Secondary Outcomes (4)

• Patient pain

  during the colposcopy

• Patient pain

  immediately after the colposcopy

• Patient anxiety

  during the colposcopy

• Surgical complications

  72 hours after colposcopy

Study Arms (3)

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.

Device: Virtual reality headset before colposcopy; Device: Virtual reality headset during colposcopy

VR before colposcopy

EXPERIMENTAL

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

Device: Virtual reality headset before colposcopy

Interventions

Virtual reality headset before colposcopy DEVICE

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

VR before and during colposcopy; VR before colposcopy

Virtual reality headset during colposcopy DEVICE

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

VR before and during colposcopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Marien Hospital Herne

Herne, North Rhine-Westphalia, 44625, Germany

Location

Related Publications (1)

• Hecken JM, Halagiera P, Rehman S, Tempfer CB, Rezniczek GA. Virtual Reality for Anxiety Reduction in Women Undergoing Colposcopy: A Randomized Controlled Trial. J Low Genit Tract Dis. 2023 Jul 1;27(3):223-229. doi: 10.1097/LGT.0000000000000745. Epub 2023 May 11.

  PMID: 37166026 RESULT

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Clemens B Tempfer, MD

  Ruhr-Universität Bochum / Marien Hospital Herne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking possible due to the nature of the intervention (using a virtual reality headset vs. not using a VR headset)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized open interventional study

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 12, 2021
• Study Start: May 25, 2021
• Primary Completion: July 7, 2022
• Study Completion: July 10, 2022
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)