Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Impact of a virtual reality
研究概览
简要总结
Patients at high risk of preterm birth are hospitalized with an high stress for their child's future. In order to better prepare the patient to a possible preterm delivery we use to propose her a visit of the neonatology unit. However, as a result of their obstetrical condition and of the pediatric staff disponibility, this visit is not always possible. Virtual Reality (VR) is well known to provide an immersive experience while staying in a unique place. Our project is to propose a virtual visit of the delivery room, neonatology unit and intensive care unit to all hospitalized patients at risk of preterm delivery in order to prepare and decompress them.
详细描述
Most of the future parents are unprepared to outcomes of their premature child and the neonatology unit visit has a demonstrated anxiolytic effect on them (decrease of 6.7 points on the State Trait Anxiety Inventory-form Y scale (STAI-Y1)) unfortunately, as a result of their obstetrical condition and of the pediatric staff disponibility, the visit of the neonatology unit is not always possible in time.
Furthermore VR is known to be an immersive experience wich had already proved its comforting interest during delivery or to prepare patient to a planned caesarean.
In this study we propose to all hospitalized and high risk of delivery early patients a virtual visit of the neonatology unit from their sit in the calm space of their room. If the patient doesn't tolerate or has some VR contraindication : a virtual visit is possible on digital tablet. The visit is presented after the foetal lung maturation by 48h of Betamethasone. Patients complete a STAI-Y-A survey before and after the experience and a Simulator Sickness Questionnaire (SSQ) questionary to evaluate their tolerance. All medical informations can be found in the medical record.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Hospitalized patient
- •Patient with high risk of preterm delivery
- •> 24 Week of Gestation (WG) et ≤ 34 WG
- •Patient who received corticosteroids for fetal lung maturation in the previous 24h
- •Patient > 18 years old
排除标准
- •Patient no speak french
- •no read french
- •Guardianship, curatorship, or under the protection of a conservator
- •Foetus vital prognosis engaged
- •Medical contraindication to virtual reality: Epilepsy, bipolarity, severe motion sickness ( evaluated by the patient herself : history of nausea, sweat, emesis during car, boat or airplane transportation … +/- preventive therapy)
研究组 & 干预措施
Virtual reality
干预措施: Virtual reality (Other)
结局指标
主要结局
Impact of a virtual reality
时间窗: Day 1
evaluation of the impact of a virtual reality visit on the anxiety of hospitalized patients with a risk of preterm delivery with the STAI-YA questionary
次要结局
- Number of deliveries(Hours 12)
- Consumption of anxiolytics and analgesics(Day 2)
- overall satisfaction(through study completion, a maximum 18 weeks)
- % of patients wtih Visit on tablet(Hours 2)
- Average length of visit in VR(through study completion, a maximum of 18 weeks)
- Number of patients experiencing an increase in uterine contractions(Hours 12)
- Number of patients with rupture of membranes(Hours 12)
- % of patients with difficulty falling asleep(Day 2)
- % of patients with Arterial hypotension(Day 2)
- Evolution of Heart rate kinetics(Day 2)
- % of patients wtihCybercinetosis(Hours 2)
- % of patients wtih Renewal of the visit in VR(through study completion, a maximum of 18 weeks)
- % of patients wtih Visit interruption(Hours 2)