Clinical trial NCT06180317: The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy
Official title: The Effect of Virtual Reality on Anxiety and Pain During Endometrial Biopsy: A Randomised Controlled Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Biopsy
Keywords: Endometrial Biopsy
Virtual Reality
Anxiety
Pain
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* -Volunteering to participate in the research
* Answering questionnaire and scale forms completely
* Ability to read and understand Turkish
* 18 years of age or older
* STAI score of 35 and above

Exclusion Criteria:

* Unwilling to continue working
* Having any problem that prevents communication (such as impaired hearing, speech, comprehension skills),
* Having used a pharmacological agent with analgesic or anxiolytic effect or a non-pharmacological method 24 hours before the procedure
* Having any psychiatric illness
* Vertigo, vision, hearing, perception problems
* Pregnancy
* Acute pelvic inflammatory disease, acute cervical and vaginal infection

Primary outcomes:
measure: Introductory Information Form
timeFrame: between one to six months
Secondary outcomes:
measure: The State/Trait Anxiety Inventory (STAI)
timeFrame: between one to six months
measure: Visual Anolag Scale (VAS)
timeFrame: between one to six months
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: 1.Murat State Hospital
Study officials:
affiliation: 1. Murat state hospital
name: meltem yavuz, Midwife
role: PRINCIPAL_INVESTIGATOR
References: