The Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Labor Induction: a Randomized Controlled Trial (VIRTUALMAG)
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
- maximum pain felt during balloon placement
研究概览
简要总结
The labor induction concerns 22% of births in France. In the event of labor induction, in almost two thirds of cases, a cervical ripening method is used and the use of mechanical methods is observed for 8% of cervical ripening. Intra-cervical balloon placement is generally well tolerated but is frequently associated with pain and acute anxiety. There are few options for pain relief. Virtual reality, a relatively new intervention, has been studied as a distraction technique for pain relief, but never in the context of the induction of childbirth.
详细描述
It's prospective single-center, randomized, single-blind, prospective study (1:1, 2 group randomization) comparing a group of patients who benefited from the use of the virtual reality headset to a group of patients who received standard care during balloon insertion. Two groups of patients will be formed: a "standard care" group and a "standard care + virtual reality" group.
The study will take place at the Saint-Etienne University Hospital Center in the gynecology-obstetrics department.
The principal objective is to evaluate the effectiveness of the use of a virtual reality helmet on the reduction of pain during the insertion of an intra-cervical balloon for childbirth induction versus the use of standard care.
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
- 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
- •Any pregnant woman presenting to the Gynecology-Obstetrics Department of the Saint-Etienne University Hospital for an induction by Cook's balloon.
- •Patients affiliated or entitled to a social security system
- •Patients having given their agreement to participate and after signing the consent form
排除标准
- •Woman refusing to participate in the study (lack of consent)
- •Non French-speaking woman (impossibility of carrying out a good quality interview of the pregnant woman)
- •Women suffering from blindness, deafness or epilepsy against the use of the virtual reality helmet.
- •Participation in another interventional study.
- •Patient under guardianship or curatorship
- •Patient subject to a legal protection measure or unable to express their consent
研究组 & 干预措施
standard care (control group)
Patient benefit the standard care during the placement of Cook's balloon (standard care).
standard care and virtual reality (experimental group)
Patient benefit the standard care during placement of Cook's balloon (standard care) with the use of a virtual reality.
干预措施: Virtual Reality Headset (Device)
结局指标
主要结局
maximum pain felt during balloon placement
时间窗: Day: 0
Measurement of the maximum pain experienced during the placement of the intra-cervical balloon using a numerical scale from 0 to 10: 0 = no pain, 10 = maximum pain.
次要结局
- Nociception Level Index (NOL™) during balloon placement(Day: 0)
- patient's satisfaction with the use of the virtual reality headset.(Day: 0)
- Anxiety felt during balloon placement(Day: 0)
- difficulty of balloon placement by the midwife during induction of labor(Day: 0)
- average pain felt during balloon placement(Day: 0)
- midwife's satisfaction with the use of the virtual reality headset.(Day: 0)
- tolerance of the virtual reality helmet by the patient.(Day: 0)