Clinical Trials Directory

Trials / Completed

CompletedNCT06180317

The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy

The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy: A Randomised Controlled Experimental Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Kırklareli University · Academic / Other
Sex
Female
Age
18 Years – 85 Years
Healthy volunteers
Accepted

Summary

The aim of this study was to reduce the anxiety and pain felt during endometrial biopsy procedure.

Detailed description

Endometrial cancers are among the most common gynaecological cancers globally, while abnormal uterine bleeding is a common gynaecological problem.Endometrial biopsy is a safe method frequently used in gynaecology to evaluate abnormal or postmenopausal uterine bleeding. It is a rapid and cost-effective medical procedure performed to examine the endometrium to detect the presence of endometrial hyperplasia, malignancy or other pathological conditions. Since early diagnosis and correct treatment can affect the prognosis of the disease, endometrial biopsy is considered an important diagnostic and screening tool for women's health. Although endometrial biopsy is a painless or mildly painful procedure, approximately half of the patients experience pain of different intensity during the procedure.Endometrial biopsy, which is an invasive procedure, can trigger anxiety in women and increase the perceived pain experience and severity by reducing pain tolerance during the procedure. Effective management of anxiety, which can also exacerbate the pain experienced during endometrial biopsy procedure, can increase women's comfort and satisfaction. Therefore, anxiety management may be effective in helping women cope with the problems experienced during the endometrial biopsy procedure. While many alternative methods are used to reduce anxiety in the literature (acupressure, meditation, laughter therapy, art therapy), the therapeutic effect of virtual reality has also been reported in studies. Virtual reality (VR) is an interactive virtual environment dating back to the 1960s, where the user experiences the virtual world by feeling "there" in the virtual world thanks to computer technologies. It represents complex technologies in which visual, auditory and tactile multisensory inputs are integrated into a 3D environment. It is a virtual space that can include hand or body tracking sensors with a VR headset and expands up to 360 degrees, offering users experiences similar to those in the real world. In addition, VR is frequently used in various sectors such as education, gaming, simulation and design, as well as in the field of health. A randomised clinical trial by Chiu et al. showed that virtual reality was effective in reducing anxiety in patients. The results of another study conducted by Yamashita et al. revealed that virtual reality improved anxiety and pain. When the studies in the literature were examined, no study on the effect of virtual reality on anxiety and pain that may be experienced during endometrial biopsy procedure was found. In this study, it was aimed to determine the effect of virtual reality use on anxiety and pain during endometrial biopsy.

Conditions

Interventions

TypeNameDescription
OTHERVirtual realityParticipants will view a specific relaxing and distracting scenario using virtual reality (VR) for approximately 7-8 minutes from one minute before the procedure until the end of the procedure. Assessment will be performed with STAI and VAS just before the endometrial biopsy procedure, VAS during the procedure and again with STAI and VAS after the procedure.

Timeline

Start date
2024-03-01
Primary completion
2024-11-25
Completion
2024-11-28
First posted
2023-12-22
Last updated
2025-01-09

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06180317. Inclusion in this directory is not an endorsement.

The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy (NCT06180317) · Clinical Trials Directory