跳至主要内容
临床试验/NCT06180317
NCT06180317已完成不适用

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

Kırklareli University2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Introductory Information Form

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • -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

排除标准

  • 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

结局指标

主要结局

Introductory Information Form

时间窗: between one to six months

The form consists of questions about socio-demographic and endometrial biopsy

次要结局

  • The State/Trait Anxiety Inventory (STAI)(between one to six months)
  • Visual Anolag Scale (VAS)(between one to six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayca Solt Kirca

Associate Professor

Kırklareli University

研究点 (2)

Loading locations...

相似试验

The Effect of Virtual Reality on Anxiety and Pain... | 临床试验