Recovery With Virtual Reality for Stress & Pain (ReVRS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Region Skane
- 入组人数
- 140
- 主要终点
- Quality of Postoperative Recovery Measured With QoR-15
研究概览
简要总结
This randomized controlled trial will evaluate whether a brief preoperative virtual reality intervention reduces anxiety and improves early recovery in adults undergoing elective gynecological surgery. Approximately 140 participants will be randomly assigned in a 1:1 ratio to either virtual reality in addition to usual care or usual care alone. The virtual reality intervention will consist of approximately 10-20 minutes of an immersive relaxation experience before surgery. The primary outcome is the change in preoperative anxiety measured before and after the intervention. Secondary outcomes include postoperative quality of recovery, pain, opioid consumption, postoperative nausea and vomiting, and early recovery-related healthcare outcomes.
详细描述
Preoperative anxiety and postoperative pain may negatively affect patients' recovery after surgery. Virtual reality may provide a non-pharmacological method of distraction and relaxation, but its effect on perioperative anxiety and early postoperative recovery requires further evaluation.
This prospective, randomized, parallel-group controlled trial will include approximately 140 adults undergoing elective gynecological surgery. After providing informed consent, participants will be randomized in a 1:1 ratio to one of two groups:
- Virtual reality plus usual perioperative care.
- Usual perioperative care alone.
Participants assigned to the intervention group will use a virtual reality headset for approximately 10-20 minutes before surgery and view an immersive relaxation environment. The intervention may be discontinued at any time if the participant experiences discomfort, nausea, dizziness, anxiety, or other adverse symptoms.
The primary outcome is the change in preoperative anxiety from immediately before to immediately after the intervention period, assessed using the State-Trait Anxiety Inventory-State scale and/or a numerical rating scale for anxiety.
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
盲法说明
Open-label study because participants and clinical staff are aware of whether the preoperative virtual reality intervention is administered.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Scheduled to undergo elective gynecological surgery according to the study protocol at a participating center where virtual reality can be provided.
- •Able and willing to provide informed consent for study participation, 1:1 randomization, and use of virtual reality.
排除标准
- •Increased risk of adverse effects related to virtual reality, including pronounced motion sickness, claustrophobia, or photosensitive epilepsy.
- •Active substance use disorder or active misuse of alcohol or illicit drugs.
- •Severe chronic pain and/or regular preoperative opioid treatment, as defined in the study protocol.
结局指标
主要结局
Quality of Postoperative Recovery Measured With QoR-15
时间窗: 24 hours after surgery
Postoperative recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
次要结局
- Change in Preoperative Anxiety(From immediately before to immediately after the intervention, approximately 10-20 minutes)
- Postoperative Pain Intensity(Up to 72 hours after surgery)
- Postoperative Opioid Consumption(During the first 24 hours after surgery)
- Incidence of Postoperative Nausea and Vomiting(During the first 24 hours after surgery)
- Duration of Stay in the Post-Anesthesia Care Unit(On the day of surgery)
- Quality of Recovery at 72 Hours Measured With QoR-15(72 hours after surgery)
- Quality of Recovery on Postoperative Day 7 Measured With QoR-15(7 days after surgery)
- Quality of Recovery on Postoperative Day 10 Measured With QoR-15(10 days after surgery)