NCT06811259

The Effect of Virtual Reality on Pain and Anxiety During Colposcopic Biopsy: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mersin University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The study was planned as a prospective, two-arm (1:1) randomized controlled experimental study to determine the effect of virtual reality applied during colposcopic biopsy on pain and anxiety. The research hypothesis of the research are as follows; H1a: There is a difference between the pain levels of the virtual reality group and the control group after colposcopic biopsy. H1b: There is a difference between the anxiety levels of the virtual reality group and the control group after colposcopic biopsy.

Detailed description

Methods: In the study, 82 women who underwent colposcopic biopsy at Mersin University Hospital Gynecological Oncology Polyclinic were randomly assigned to experimental and control groups. Before the application, new protective covers will be attached to the headset parts of the virtual reality (VR) glasses that the researchers already have for each woman in the experimental group. Videos with forest and sea views will be presented to the woman's preference through the VR program loaded on the phone, the video selected by the woman will be opened and the phone will be inserted into the VR glasses. After the woman is positioned for the gynecological surgical procedure, the VR glasses will be put on and will remain on during the procedure. The VR application will be terminated after the colposcopic biopsy is completed. The Visual Analog Scale (VAS) will be filled in during the procedure and 15 minutes after the colposcopic biopsy, and the State-Trait Anxiety Inventory (STAI-S) will be filled in before and 15 minutes after the colposcopic biopsy. Only standard care will be given to women in the control group during colposcopy. The primary expected outcome of the study is the effect of virtual reality on pain in women undergoing colposcopic biopsy. The secondary expected outcome of the study is to determine the effect of virtual reality on anxiety.

Conditions

• Pain and Anxiety

Interventions

Type	Name	Description
OTHER	Virtual reality (in experimental group)	Virtual reality application is performed with virtual reality glasses. Virtual reality glasses are a simulation model that provides participants with the opportunity to communicate with a dynamic environment created by computers and gives them a sense of reality. Virtual reality glasses, which have a mechanism compatible with smart phones, allow videos downloaded to mobile phones or watched directly via the internet to be viewed at a 360-degree angle. The two lenses on the device provide panoramic viewing by dividing the image into two equal parts. The bands on the front of the device that fits the face are flexible and prevent the device from slipping from the face. The buckles on the back are adjustable and provide ease of use. Thanks to the proximity sensor on the device, images can be zoomed in and out to obtain a clearer image. Thanks to the device holder on the sides, the phone can be easily placed and removed from the device. Again, videos can be advanced or changed with the tou
OTHER	Standart care	Women in the control group will receive only standard care during colposcopy

Timeline

• Start date: 2025-01-28
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2025-02-06
• Last updated: 2026-02-10

Locations

1 site across 1 country: Turkey (Türkiye)