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

NCT ID: NCT06811259

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-28
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental (VR) group

For the women in the experimental group, new protective covers will be placed on the headset parts of the VR glasses that the researchers already have before the application. Videos with forest and sea views will be presented to the woman's preference via the VR program loaded onto the phone, the video selected by the woman will be opened and the phone will be inserted into the virtual reality glasses. After the woman is positioned for the gynecological surgical procedure, the virtual reality glasses will be put on and will remain on throughout the procedure. The virtual reality application will be terminated after the colposcopic biopsyis 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 the colposcopic biopsyand 15 minutes after the colposcopic biopsy.

Group Type: EXPERIMENTAL

Virtual reality (in experimental group)

Intervention Type: OTHER

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

Control group

Women in the control group will receive only standard care during colposcopic biopsy. The Visual Analog Scale (VAS) will be completed during the procedure and 15 minutes after the colposcopic biopsy, and the State-Trait Anxiety Inventory (STAI-S) will be completed before and 15 minutes after the colposcopic biopsy.

Group Type: OTHER

Standart care

Intervention Type: OTHER

Women in the control group will receive only standard care during colposcopy

Interventions

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

Intervention Type: OTHER

Standart care

Women in the control group will receive only standard care during colposcopy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women over the age of 18,
• Subjected to colposcopic biopsy,
• Not using a medication that directly affects vital signs,
• Not using antidepressants, anxiolytics or sedatives,
• Not using analgesics or anesthetics 24 hours before the procedure,
• Not having any psychiatric illness,
• Not having vision, hearing or perception problems,
• Not having communication problems (can speak Turkish),
• Women who agree to participate in the study verbally and in writing.

Exclusion Criteria

• Women under the age of 18,
• Those who have not undergone colposcopic biopsy,
• Those who are taking a medication that directly affects vital signs,
• Those who are taking antidepressants, anxiolytics and sedatives,
• Those who are taking analgesics or anesthetics 24 hours before the procedure,
• Those who have any psychiatric illness,
• Those who have vision, hearing and perception problems,
• Those who have communication problems (cannot speak Turkish),
• Those who have diseases that cause movement sensitivity,
• Those who cannot watch the entire video,
• Women who do not accept to participate in the research verbally or in writing.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Ahu AKSOY

Asst. Prof, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mersin University

Yenişehir, Mersin, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Schmid BC, Marsland D, Jacobs E, Rezniczek GA. A Preparatory Virtual Reality Experience Reduces Anxiety before Surgery in Gynecologic Oncology Patients: A Randomized Controlled Trial. Cancers (Basel). 2024 May 17;16(10):1913. doi: 10.3390/cancers16101913.

Reference Type: RESULT

PMID: 38791991 (View on PubMed)

Oz T, Demirci N. The Effect of Virtual Reality, Music Therapy, and Stress Ball Application on Pain and Anxiety During Outpatient Gynecological Procedures: A Randomized Controlled Trial. J Perianesth Nurs. 2024 Dec;39(6):1034-1041. doi: 10.1016/j.jopan.2024.01.022. Epub 2024 May 25.

Reference Type: RESULT

PMID: 38795085 (View on PubMed)

Other Identifiers

002

Identifier Type: -

Identifier Source: org_study_id