Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- visual analog scale (EVA)
研究概览
简要总结
Compare the maximum pain and anxiety experienced between the group using a virtual reality headset and the control group in an adult woman during a hysterosalpingography examination
详细描述
In France, 1 couples out of 5 consults for suspected infertility. Hysterosalpingography is the first line diagnostic examination in this course and can sometimes be therapeutic. This gynecological examination is invasive in nature, this exam requires an administration of iodinated contrast product by the endocavitary route.
Hysterosalpingography is the most painful examination in this treatment path and pain's assessment is classified as strong by the French National Authority for Health (Haute Autérité de Santé) and anxiety-inducing. For these patients, drug analgesic treatments remain ineffective or contraindicated in outpatient mode. Ionizing irradiation is a constraint that makes hypnosis unsuitable.
Several studies show the contribution of a virtual reality headset in reducing pain and anxiety by inducing patients in an hypnotic environment. This tool standardizes interventions based on changes in consciousness. It is an easy-to-use, non-drug analgesia with few side effects and inexpensive.
The environment offered by this medical device is based on evidence to peacefully escort patients on a journey of natural elements. Calm music is made up of key elements of musical therapy. A medical anesthesiologist and hypnotherapist wrote the hypnotic induction. And, the voice is the one of an experienced sociologist in practice. A simple meditation modeled on heart synchronization sets a persistent goal during this immersion.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients over 18 years old
- •patients with a prescription for hysterosalpingography
- •patients able to answer the questionnaire independently (French-speaking or understanding French)
- •informed consent, signed by the patient
- •patients benefiting from a social security scheme or benefiting through a third party
排除标准
- •patients with a contraindication to virtual reality headset.
- •refusal to participate in the study
- •Contraindication to the realization of hysterosalpingography (pregnancy / lactation or infection)
- •patient under guardianship, curatorship or subordination
结局指标
主要结局
visual analog scale (EVA)
时间窗: through study completion, an average of 1 year
The patient rates her pain level between 0 and 10. The standard question is: "From 0 to 10, with 0 absence of pain and 10 maximum pain, how much will you rate the maximum pain experienced during your examination?"
次要结局
- - Cybersickness evaluation(through study completion, an average of 1 year)
- Dosimetry(through study completion, an average of 1 year)
- Time of exam(through study completion, an average of 1 year)
- anxiety assessment(through study completion, an average of 1 year)