A Randomized Control Trial for Assessing Virtual Reality for Perioperative Anxiolysis and Postoperative Pain Modulation in Adolescents Undergoing MIRPE Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in anxiety
研究概览
简要总结
In this randomized control trial, investigators would like to assess as primary objective the effectiveness of VR in anxiolysis via using State Trait Anxiety- Inventory test various time during the perioperative period with recorded physiologic data. As a secondary objective they are investigating the use of VR in the postoperative period for pain modulation via using pain numeric rating scales (NRS), monitoring physiologic data, and collecting information on painkiller demand of the patients.
详细描述
This prospective, randomized controlled trial will be conducted with participants from the Paediatric Center, Semmelweis University, a tertiary level health care centre based in Budapest, Hungary. We evaluate the effects of VR immersion on reducing perioperative anxiety and postoperative pain.
Participants will be asked to wear a VR headset for preferably an hour before and after the surgery. Patients will be asked to fill out three anxiety tests meanwhile investigators will record their vital parameters (HR, RR, SpO2, BP): on admission, in the operating room and on the surgical ward on the day after surgery. In the first postoperative day vital parameters, analgesic demand and NRS score will be recorded to follow patients pain status.
Researchers will compare VR group to control group to see if anxiety and pain was different among those who recieved the VR headset.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient between 13-18 years old
- •reported chest deformity (pectus excavatum/ carinatum)
- •patients undergoing MIRPE surgery in general anesthesia
- •Hungarian fluency
- •willing to comply with study procedures.
排除标准
- •gross cognitive impairment that would interfere with the ability to consent or complete study procedures.
- •Head injury
- •Head infection
- •Altered mental status (independently from midazolam)
- •Scabies or louse
- •Dizziness or vertigo
- •Blindness or severe vision loss
- •Lack of parental/ guardian or patient consent
- •Those, who has a head deformity, so VR headset does not fit well
结局指标
主要结局
Change in anxiety
时间窗: 1-2 days
Anxiety assessed by STAI-S and STAI-T questionnaires level of anxiety will be assessed using the State Trait Anxiety-Inventory. The test is composed of 2 parts: STAI-S (How does the patient feel right now?) and STAI-T (How does the patient feel on average?). Both questionnaires contain 20 questions with answers rating from 1 to 4.
次要结局
- Change in pain and vital parameters(1-2 days)
研究者
Agnes Jermendy MD PhD MPH
Professor of Pediatrics
Semmelweis University