The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization: a Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Treatment satisfaction and immersion
研究概览
简要总结
Ultrasound-guided oocyte retrieval (OR) is a short, but oftentimes painful procedure, during which the follicles are punctured trans-vaginally to obtain oocytes for in vitro fertilization (IVF). Conscious sedation is the most commonly used method of pain relief, yet several studies have shown that more than half of women report moderate to high levels of pain and up to 7% of women report extreme or unacceptable levels of pain during OR. Adjuvant virtual reality (VR) therapy has been explored to reduce psychological stress during dental procedures, burn wound care, colonoscopy, as well as other minor procedures. Hence, the purpose of this study is to evaluate the use of VR technology during IVF treatment, particularly with respect to tolerability, patient satisfaction, and pain reduction during oocyte retrieval.
详细描述
Background / Rationale
Ultrasound-guided oocyte retrieval (OR) is a short, but oftentimes painful procedure, during which the follicles are punctured trans-vaginally to obtain oocytes for in vitro fertilization (IVF). Conscious sedation is the most commonly used method of pain relief, yet several studies have shown that more than half of women report moderate to high levels of pain and up to 7% of women report extreme or unacceptable levels of pain during OR. Psycho-social factors such as anxiety, previous negative experiences with gynecological examinations, and perceived lack of control are important predictors of OR-related pain. This finding is consistent with the multidimensionality of the pain experience. Although several adjuvant therapies have been proposed to reduce psychological stress during ART (assisted reproductive technology) therapy, their impact on the OR experience has been mixed.
Virtual reality (VR) allows users to engage in a fully immersive simulated environment using an advanced visual and auditory system. Multimodal stimuli contribute to a sense of actual presence/immersion in the virtual world, thus making the VR experience distinct from passive visual or auditory stimuli. The utility of VR therapy has been explored for numerous health applications, showing positive outcomes in clinical conditions such as dental procedures, burn wound care, colonoscopy, as well as other minor procedures. A recent systematic review of 39 RCTs (randomized clinical trials) concluded that VR's immersive, entertaining effects are useful for redirecting a patient's attention away from painful treatment experiences and reducing anxiety, discomfort, and unpleasantness. Several studies have shown a significant decrease in pain perception and anxiety scores when treated with VR, as measured by anxiety questionnaires, pulse rate reduction, and electroencephalogram changes compared with controls. To the best of our knowledge, there are no published studies that examine the application of VR technology during IVF treatment, particularly with respect to tolerability, patient satisfaction, and pain reduction during oocyte retrieval.
Purpose
The primary objectives of this pilot study are to evaluate patient acceptance, perceived utility, and adverse effects of VR technology during the oocyte retrieval procedure as measured by validated VR-engagement and anxiety-related questionnaires
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All adults undergoing their first oocyte retrieval
排除标准
- •severe visual impairment
- •contraindications to using VR technology according to manufacturer specifications including:
- •severe motion sickness
- •epilepsy/previous seizure
- •claustrophobia
- •current migraine
- •heart disease
- •use of medical devices such as cardiac pacemaker or hearing aids
结局指标
主要结局
Treatment satisfaction and immersion
时间窗: 10 minutes
measured by the IGroup Presence Questionnaire (IPQ) -Scaled 14-item questionnaire administered post-OR
Adverse events
时间窗: 20 minutes
measured by the Simulator Sickness Questionnaire (SSQ) - Scaled 16-itemquestionnaire administered pre-OR and post-OR.
Procedural anxiety
时间窗: 20 minutes
measured by the State-Trait Anxiety Inventory (STAI) Questionnaire -Scaled 20-item questionnaire administered at recruitment, pre-OR, and post-OR.
次要结局
- Pain intensity(10 minutes)
- Total opioid and benzodiazepine use(20 minutes)
- Duration of procedure(20 minutes)
- Total number of oocytes retrieved / peak E2(20 minutes)
- Total number of MII oocytes retrieved / number of follicles ≥ 17mm on day of trigger(20 minutes)
研究者
Claire Jones
Associate Professor
University of Toronto