Virtual Reality in Elective Caesarean Births Study (VREC)- A Feasibility Study for a Virtual-reality Based Tool to Improve Patient Reported Outcomes Following Elective Caesarean Section.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- patient feedback questionnaire after watching virtual reality education film
研究概览
简要总结
This study will establish the safety of a known intervention in a novel setting. It will assess how maternal anxiety during the peri-operative period of an elective cesarean section (eCS) is affected by the introduction of a virtual reality (VR) tool. A cesarean section is the most common operation performed in the world. Indeed, locally, we perform approximately 450 eCS annually, equating to 10% of all births. High maternal anxiety in the peri-operative period is well recognised. Although anxiety is considered to be an emotional response it has many physiological consequences which can confer significant morbidity. These include an increased pain perception (with higher analgesic requirement), increased length of hospital stay and a higher risk of infection. Providing high-quality pre-operative information to help patients reduce their anxiety has been used in other medical fields. The use of VR to deliver this information to paediatric populations has been shown to be particularly effective. VR has had limited scope outside of this population and we wish to change this.
Women booked for an eCS at the Royal United Hospital (RUH) will be eligible to participate. A bespoke VR tool (a video of a woman's journey through the process of an elective section at the RUH) will be shown to one group of women prior to eCS whilst another group will receive the standard preoperative information.
A series of quantitative and qualitative data points will be collected across both groups assessing their anxiety and satisfaction with the birthing process throughout the peri-operative period. The two groups will then be compared.
Recruitment will occur prior to the birth during scheduled appointments with the Midwifery team. If proven to be a safe intervention, we hope to run a larger study aiming to determine the efficacy and role of VR in improving maternal outcomes in cesarean births.
详细描述
The Royal College of Obstetrics and Gynaecology (RCOG) has a well-defined framework for involving pregnant women in research studies (clinical governance document 6a). They promote research in obstetrics but stress the key is that research should be completed 'with women, not on women'. For each step of the study, the RCOG framework will be adhered to.
Overview of the study and why it is important
An elective caesarean section (eCS) can be a very anxiety inducing time. Prior to the research project commencing, we developed a questionnaire that all women at Royal United Hospital, Bath (RUH) completed prior to their eCS. This demonstrated consistently high anxiety levels across obstetric populations, including those who had previous emergency caesarean sections. The main source of anxiety was often a fear 'of the unknown' and not knowing what to expect.
Although anxiety is considered to be an emotional response it has many physiological consequences which can confer significant morbidity. These include an increased pain perception (with higher analgesic requirement), increased length of hospital stay and a higher risk of post-operative wound infection.
The purpose of this study is to assess the safety of a virtual reality education film (VREF). The VR will provide a 360degree, 3-dimensional virtual tour demonstrating what will happen on their day of delivery, from entering Bath Birthing Centre through to being on the postnatal ward with their new baby. They will be able to watch this, if they choose, using a head set to make the experience more realistic. The ultimate purpose of the film is to reduce that fear of the unknown by giving patients and their families a detailed view of their upcoming journey.
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
- •Have had the decision for elective LSCS by 38 weeks gestation.
- •Has never had an emergency or elective section previously
- •Have a procedure planned and performed as a category 4 LSCS (an elective LSCS booked at a time that suits both the woman and obstetric team)
- •Have use of an android or iOS operating system smartphone or tablet device.
- •Have access to the internet.
- •Have an active email address.
- •Have capacity to consent to participate in the study.
排除标准
- •Patient <18 years of age
- •Patient refusal
- •Patients who have had an emergency or elective LSCS previously.
- •Patients with a history of anxiety disorders
- •Patients with medical or obstetric co-morbidities requiring pre-determined admission to maternity HDU care
- •Congenital structural abnormalities requiring pre-determined admission to NICU
- •Patients where spinal anaesthesia is contra-indicated
- •Women who have English of an insufficient standard to comprehend the consent and assessment process
- •Prisoners
研究组 & 干预措施
Virtual reality educational film
The intervention arm will receive the standard antenatal care and pre-operative education plus will view the Virtual Reality Educational Film
干预措施: Virtual Reality Educational Film (Other)
Control arm
The control arm will receive all standard antenatal care and pre-operative education
结局指标
主要结局
patient feedback questionnaire after watching virtual reality education film
时间窗: from enrollment up to 1 weeks post cesarean section
Patients will complete a feedback questionnaire to assess if a pre-operative virtual reality education film is safe, feasible and acceptable intervention in women who have had an elective Cesarean section.
次要结局
- State Trait Anxiety Inventory Scale 5(from enrollment up to 48 hours post cesarean section)
- Visual Analogue Scale for Anxiety(from enrollment up to 48 hours post delivery)
- Serum cortisol(From enrollment up to 48 hours post delivery)
- Patient satisfaction scores(enrollment up to 48 hours post cesarean section)
- Visual Analogue Scores (VAS) for pain(up to 48 hours post cesarean section)
- Analgesia consumption(from delivery up to 48hours post delivery)
研究者
Rebecca Leslie
Consultant in Anaesthesia
Royal United Hospitals Bath NHS Foundation Trust