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

Mersin University

Status: Invitation-only

Conditions: Pain and Anxiety

Treatments: Other: Standart care; Other: Virtual reality (in experimental group)

Study type: Interventional

Funder types: Other

Identifiers

NCT06811259

002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Experimental (VR) group

Experimental group

Description:

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.

Treatment:

Other: Virtual reality (in experimental group)

Control group

Other group

Description:

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.

Treatment:

Other: Standart care