e-Natureza Blue Care - Impact of Virtual Reality on Pain Perception, Mood States, and Analgesic Use in Patients With Cancer Pain: Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Visual Analogic Scale for Pain
研究概览
简要总结
This randomized clinical trial aims to evaluate the effectiveness of immersive nature-based virtual reality in managing chronic pain among oncology patients. The study seeks to expand non-pharmacological treatment options and contribute to the therapeutic arsenal available for chronic pain management in cancer care.The intervention utilizes immersive videos of diverse Brazilian natural environments to promote analgesic and emotional relief.
详细描述
Pain is a global health issue and remains the most feared symptom among cancer patients. With over 14 million new cancer diagnoses annually and projections suggesting this number will triple by 2030. The majority of patients are diagnosed at an advanced stage, where pain is the predominant complaint. The concept of total pain, as described in palliative care, highlights the need for a multidimensional approach that addresses physical, psychological, social, and spiritual aspects.
In the management of chronic pain, complementary therapies such as acupuncture, meditation, and massage have gained prominence for offering holistic benefits without the side effects associated with pharmacological treatments. Another promising complementary approach involves exposure to natural environments. Immersive Virtual Reality (VR) is an innovative strategy that provides distraction and reduces pain perception by transporting patients to engaging, nature-based virtual settings.
This study is a randomized, controlled, parallel-group clinical trial designed to investigate the impact of an immersive virtual reality (VR) intervention with nature-themed content (blue spaces) on pain and emotional well-being in hospitalized cancer patients. The research will be conducted in three oncology units of a large private hospital in São Paulo, Brazil.
A total of 130 adult oncology inpatients experiencing chronic pain will be randomly assigned to either the intervention or control group. Participants in the control group will receive standard pain management as provided by the hospital's pain control team, guided by electronic medical records, and institutional pain protocols. The intervention group will receive the same standard care, plus a VR session using the Oculus Go headset and 360-degree nature videos with synchronized natural sounds (e.g., beach, waterfall, birdsong), lasting approximately 8 minutes.
Data will be collected using the following validated instruments:
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
- Single (Outcomes Assessor)
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
- •hospitalized oncological patients with chronic pain.
- •both sexes
- •aged 18 years or older
- •preserved clinical condition and communication abilities that allow participation in the study
- •report pain documented in the electronic medical record
排除标准
- •Patients who are unable to tolerate wearing the virtual reality (VR) headset for at least 8 minutes
- •blind patients
- •patients who experience any side effects or worsening clinical condition during the interview/intervention period
- •patients undergoing other complementary treatments
研究组 & 干预措施
Intervention - Nature-based Virtual Reality
Participants will view an 8-minute 360° 3D immersive video featuring natural Brazilian blue environments (beach, waterfall) developed using the Oculus Go. Pre- and post-intervention assessments will include: Visual Analog Scale (VAS), The Positive and Negative Affect Schedule (PANAS), After 24h, the Analgesic Experience Form will be completed. A sociodemographic/clinical questionnaire and Connectedness to Nature Scale (CNS) will be applied only pre-intervention.
干预措施: Nature-based virtual reality (Behavioral)
Control
Participants in the control group will receive standard care. They will undergo standard pain management as per institutional pain protocols. The same outcomes assessment will occur at the same time intervals as in the intervention group.
干预措施: Standard Pain Management (Drug)
结局指标
主要结局
Visual Analogic Scale for Pain
时间窗: Immediately post-intervention for an unique virtual reality intervention
Change from Baseline in self-reported pain intensity using a 0-10 Visual Analog Scale at post intervention. Will be applied the Visual Analogue Scale - VAS. It is one of the most used instruments for pain assessment with a score from 0 to 10 that allows the patient to evaluate the pain of the procedure through a visual analogue scale numbered from zero to ten, with zero no pain, ten being the worst pain ever felt in life.
Frequency of analgesic administration Frequency of analgesic administration Frequency of analgesic administration
时间窗: 24 hours post-intervention
This outcome will assess the number of doses of analgesics administered to participants in the control and experimental groups within 24 hours following each intervention session. Analgesics include opioids, non-opioids, and adjuvant medications. Data will be collected from medical records.
Total dosage of analgesics administered
时间窗: 24 hours post-intervention
This outcome will assess and compare the total dosage (in milligrams) of analgesics administered to participants in the control and experimental groups within 24 hours after each intervention session. The analysis will include opioids, non-opioids, and adjuvant medications. Data will be extracted from medical records.
Type of analgesics administered
时间窗: 24 hours post-intervention
This outcome will identify and compare the types of analgesics (opioids, non-opioids, and adjuvant medications) used by participants in the control and experimental groups within 24 hours following each intervention session. Medication classes will be categorized based on pharmacological criteria.
次要结局
- The Positive and Negative Affect Schedule (PANAS)(Immediately post-intervention for an unique virtual reality intervention)
研究者
Eliseth Ribeiro Leao
Nurse Scientist
Hospital Israelita Albert Einstein