Effect of Virtual Reality on Anxiety and Pain During Trans-vaginal Ultrasound for Endometriosis: A Prospective Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Change in anxiety level measured by State Anxiety Inventory (STAI-S)Anxiety levels are assessed using the Stating
研究概览
简要总结
The goal of this study to evaluate whether virtual reality (VR)-based technology, designed to promote relaxation and support pain self-management, can reduce anxiety and pain during trans-vaginal ultrasound (TVUS) for endometriosis.
Participants, women undergoing TVUS for endometriosis will be randomly assigned to either VR distraction group (VR-TVUS) or a standard examination group (control).
Anxiety and pain levels will be assessed immediately before and after the TVUS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 50 years.
- •Confirmed or suspected diagnosis of endometriosis.
- •Scheduled to undergo transvaginal ultrasound examination.
- •Ability to understand the study procedures and independently complete study questionnaires.
- •Provided written informed consent.
排除标准
- •History of epilepsy or seizure disorders.
- •History of migraines.
- •Visual or hearing impairment.
- •Diagnosed anxiety disorders.
- •Claustrophobia.
- •Current symptoms of dizziness or nausea.
- •Active respiratory tract infection.
- •Any contraindication to transvaginal ultrasound examination.
研究组 & 干预措施
VR- TVUS Group
Participants undergo TVUS while using immersive virtual reality distraction
干预措施: Virtual reality - based distraction (Behavioral)
Contro Group - Standard TVUS
Participants undergo standard TVUS, without virtual reality or any additional distraction intervention.
结局指标
主要结局
Change in anxiety level measured by State Anxiety Inventory (STAI-S)Anxiety levels are assessed using the Stating
时间窗: From immediately before the TVUS to immediately after completion of the examination.
Anxiety levels are assessed using the State Anxiety Inventory (STAI-S). It includes 20 items such as "I feel calm " and "I am tense ". Participates were instructed to circle the number that best describes how they felt at that moment from 1 to 4 (from "Not at all" to "Very much so"). The STAI-S questionnaire is scored by summing the responses to the individual items and the possible scores ranges from 20 to 80, where 20-37 refers to "no or low anxiety", 38-44 to "moderate anxiety", and 45-80 to "high anxiety" (45-80). The outcome measure is the change in STAI-S score from before to immediately after the TVUS examination
次要结局
- Change in pain intensity measured by Visual Analog scale (VAS)(From immediately before the TVUS to immediately after completion of the examination.)
- Change in heart rate and blood pressure '(including mean arterial pressure) during TVUS(The outcome measure is the change in the heart rate and blood pressure from immediately before to immediately after the TVUS examination.)
研究者
Michal Zajicek
MD
Sheba Medical Center