Abadan University of Medical Sciences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale (VAS) Pain Score
研究概览
简要总结
This study aims to evaluate whether virtual reality (VR) can reduce pain and improve sleep quality during wound dressing changes in burn patients with 25-60% total body surface area (TBSA) burns, compared to standard care.
详细描述
Background:
Burn injuries are extremely painful, especially during wound dressing changes. They also cause severe sleep problems, which can slow down healing. While medicines help, they often have side effects and don't fully solve these issues. Virtual reality (VR) is a new tool that distracts the brain from pain by immersing patients in a calming digital world. This study was designed to assess if VR could help with both pain and sleep in burn patients.
Methods:
We conducted a randomized controlled trial with 60 adult burn patients who had between 25% and 60% of their body burned. All patients were stable and able to understand instructions. We randomly assigned them into two groups: one group used VR headsets during their dressing changes, and the other group received standard care without VR. Pain was measured before and after the procedure using a simple 0-to-10 scale. Sleep quality was assessed using a standard questionnaire (PSQI) before and 24 hours after the treatment.
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
盲法说明
Blinding was not feasible due to the visible nature of the VR headset and the need for participants and care providers to be aware of group assignment during the intervention. However, data collection and analysis were performed by blinded personnel.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Adult patients aged 18 to 60 years.
- •Deep partial-thickness or full-thickness burns covering 25% to 60% of total body surface area (TBSA).
- •Hemodynamic stability (systolic BP ≥90 mmHg, HR 60-100 bpm, no vasopressor use).
- •Ability to understand and comprehend Persian language.
- •Scheduled for at least one standardized, non-sedated wound dressing change procedure.
排除标准
- •- Diagnosed psychiatric or neurological disorder (e.g., schizophrenia, epilepsy).
- •Severe visual impairment (best-corrected visual acuity <20/200) or auditory impairment.
- •History of motion sickness or VR intolerance.
- •Contraindications to VR use (e.g., active vertigo, uncontrolled hypertension).
结局指标
主要结局
Change in Visual Analog Scale (VAS) Pain Score
时间窗: Immediately before and after the dressing change procedure
The primary outcome for pain was the change in the Visual Analog Scale (VAS) score from immediately before to immediately after the wound dressing change procedure. The VAS is a 10-cm scale where 0 represents "no pain" and 10 represents "worst pain imaginable." The change score (post-procedure minus pre-procedure) was calculated, with negative values indicating pain reduction.
Change in Pittsburgh Sleep Quality Index (PSQI) Total Score
时间窗: 24 hours post-intervention
The primary outcome for sleep quality was the change in the total score of the Pittsburgh Sleep Quality Index (PSQI) from baseline to 24 hours post-intervention. The PSQI is a validated self-report questionnaire assessing seven components of sleep quality over the past month. A higher score indicates poorer sleep quality. The change score (post-intervention minus pre-intervention) was calculated, with negative values indicating improvement.
次要结局
- Change in individual components of the Pittsburgh Sleep Quality Index (PSQI)(24 hours post-intervention)
研究者
Rasool Paygozar
PhD student in Health Sciences, Faculty Member, Abadan University of Medical Sciences
Abadan University of Medical Sciences