Clinical trial NCT06811259: The Effect of Virtual Reality on Pain and Anxiety During Colposcopic Biopsy: a Randomized Controlled Trial
Official title: The Effect of Virtual Reality on Pain and Anxiety During Colposcopic Biopsy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pain and Anxiety
Keywords: Colposcopy, biopsy, virtual reality, anxiety and pain, nursing
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 82
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, two arm, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Pain
timeFrame: change from during the intervention, at the end of 15 minutes
Secondary outcomes:
measure: Anxiety
timeFrame: change from before the intervention, at the end of 15 minutes
Other outcomes:
Locations:
city: Yenişehir
country: Turkey
facility: Mersin University
state: Mersin
Study officials:
References:
citation: 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.
citation: 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.