Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS Study (Virtual Reality and Schedulded Cesarean Section)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluate the feasibility of a pathway involving the use of virtual reality from patient admission to the cesarean section.
研究概览
简要总结
Cesarean deliveries account for 20.7% of all deliveries in France, according to the latest perinatal survey. At Nice University Hospital, the C-section rate over the last 5 years is around 19%.
Caesarean section patients are at greater risk of developing symptoms of anxiety, stress and depression. The post-operative period is also more painful, and there is a positive correlation between immediate post-operative pain and the risk of developing chronic pelvic pain. Numerous attempts to reduce these symptoms have been evaluated, including music therapy, relaxation techniques, acupressure and the use of preoperative melatonin.
Virtual reality has demonstrated its effectiveness in reducing pain and anxiety in other disciplines, notably pediatric surgery and neurosurgery.
In particular, several trials have demonstrated a reduction in anxiety in the paediatric population and, for pelvic procedures under local anaesthetic, during prostate biopsies or hysteroscopy in consultation, with a reduction in anxiety and pain respectively.
It has been used to provide information by showing a film about the caesarean section procedure, and has been shown to be effective in terms of patient satisfaction, but without being able to demonstrate a significant reduction in anxiety (p=0.06).
The use of virtual reality during the entire peri- and intra-operative management process (maternity stay, patient transfer to the operating room, locoregional anesthesia procedure and during the operation) has not been studied in the context of cesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Major woman ;
- •Female volunteer ;
- •Social security affiliation;
- •Admitted for scheduled caesarean section with history of caesarean section and patient's refusal to attempt vaginal delivery;
- •Informed patients who have signed the informed consent form.
排除标准
- •Speaks a language other than French;
- •Unbalanced epilepsy;
- •People unable to understand (language barrier, cognitive difficulties, cerebral palsy, etc.) and/or apply dietary advice (people institutionalized in nursing homes, retirement homes, prisons, etc.);
- •Women claiming to have had a very bad experience during their previous caesarean section.
研究组 & 干预措施
Scheduled caesarean delivery
Use of virtual reality headset during patient admission to the OR for cesarean section.
干预措施: HypnoVR© virtual reality headset (Other)
结局指标
主要结局
Evaluate the feasibility of a pathway involving the use of virtual reality from patient admission to the cesarean section.
时间窗: 18 months
Rate of acceptance of the use of the virtual reality headset during each stage of care (on admission to the maternity ward, in the delivery room before transfer to the operating room, at the patient's request in the caesarean section room after birth (in the absence of skin-to-skin contact with the newborn).
次要结局
- Evaluate patient anxiety throughout treatment(18 months)
- Evaluation of the medical team's satisfaction after surgery(18 months)
- Assessing patients' pain throughout the treatment process(18 months)
- Evaluate patient satisfaction throughout the care process(18 months)
- Assessing the impact on newborns(18 months)
- Assessment feasibility(18 months)
- Evaluation of study refusals(18 months)
- Evaluation of the impact on the course of surgery and the post-operative period(18 months)
- Assessing the impact on newborns by APGAR(18 months)