realtà Aumentata Generatrice di Ansia Zero
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- anxiety level
研究概览
简要总结
This study, titled "R.A.G.A.Z.: Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery," aims to see if using virtual reality (VR) can help children feel less anxious and experience less pain during minor orthopedic surgeries. The research will compare the effects of VR to the usual pre-surgery sedative medication.
**Study Hypotheses**
The researchers hypothesize that using VR will:
1. Reduce anxiety levels in children before and after surgery compared to standard sedative medication.
**Who can participate?**
- Children aged 7 to 12 years
- Undergoing minor orthopedic surgery lasting less than 60 minutes
- Eligible for regional anesthesia
**Study Process**
Participants will be randomly assigned to one of two groups:
- VR Group: Children will use VR headsets to immerse themselves in calming virtual environments before and during the surgery.
- Standard Care Group: Children will receive standard sedative medication before surgery.
The study will measure:
- Levels of anxiety before and after surgery using a specific anxiety meter (CAM-S).
- Stress hormone levels (cortisol, adrenaline, noradrenaline) from blood samples.
- Pain levels at different times after surgery.
- How well children cooperate during medical procedures.
- Satisfaction levels of children, parents, and surgeons.
The study is being conducted by IRCCS - Istituto Ortopedico Rizzoli in Bologna, Italy. It is a non-profit study funded by donations.
The goal is to find out if VR can reduce the need for sedatives, decrease anxiety and pain, and improve the overall surgical experience for children.
详细描述
**Detailed Description**
This study, titled "R.A.G.A.Z.: Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery," aims to evaluate the effectiveness of virtual reality (VR) in reducing perioperative anxiety and pain in children undergoing minor orthopedic surgeries. The study will compare the use of VR headsets to the traditional method of pre-surgery sedation with medication.
**Purpose of the Study**
The primary objective of this study is to determine whether VR can provide better control of anxiety in pediatric patients before and after anesthetic and surgical procedures. The study will also assess whether VR can reduce the need for sedative and pain-relief medications, thereby minimizing potential side effects and improving recovery times.
**Study Hypotheses**
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
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 7 to 12 years.
- •Scheduled for minor orthopedic surgery with a duration of less than 60 minutes.
- •Eligible for regional anesthesia.
- •Able to understand and cooperate with the study procedures.
- •Consent from both the child and their parent or legal guardian.
排除标准
- •Facial trauma that prevents the use of VR headsets.
- •Blindness or significant visual impairment.
- •Deafness or significant hearing impairment.
- •Cognitive impairments or intellectual disabilities.
- •Inability to understand the language used in the VR content.
- •Poor fit of the VR headset on the child's face.
- •Inability to understand Italian.
- •Current use of analgesics or sedatives at home.
- •Certified psychiatric diagnosis.
- •Epilepsy or history of seizures.
- •Recent head trauma, severe headaches, or vertigo.
- •Any condition deemed by the anesthesiologist to be unsafe for VR use.
- •Failure to properly apply topical anesthetics before invasive procedures.
- •Allergy to local anesthetics.
- •Surgery duration expected to exceed 60 minutes.
- •Anticipated need for general anesthesia or deep sedation requiring advanced airway management.
- •Predicted difficult venous access (DIVA)
研究组 & 干预措施
control
pre-surgery sedation
VR
virtual reality sedation
干预措施: hypno VR (Device)
结局指标
主要结局
anxiety level
时间窗: 24 hours
level of anxiety with cam-s
次要结局
- or time occupation(intraoperative)
- adverse event(24 hours)
- hormons levels(preoperative)
- pain level(24 hours)
- compliance during induction(during induction)
- drugs dosage(intraoperative)
- surgeons satisfaction(immediately after the intervention)
- parents satisfaction(immediately after the intervention)