e-Natureza Blue Care: Nature-based Virtual Reality and Pain Perception

Официальное название

e-Natureza Blue Care - Impact of Virtual Reality on Pain Perception, Mood States, and Analgesic Use in Patients With Cancer Pain: Randomized Clinical Trial.

Обзор

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.

Подробное описание

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:

Visual Analog Scale (VAS) for pain intensity,

PANAS for positive and negative affect,

Nature Connectedness Scale (NCS),

Sociodemographic and clinical questionnaire,

Analgesic Use Form, developed by researchers to quantify medication use and pharmacological class.

Ethical approval was obtained (CAAE: 86844425.5.0000.0071), and all participants will provide written informed consent. If the results are positive, the intervention will be made available to the hospital's pain management team for broader implementation in clinical practice.

Вмешательства

• Поведенческое Nature-based virtual reality
  Participants in this group will receive standard pain management care plus one session of immersive virtual reality (VR) using Oculus Go headsets. The session consists of viewing a nature-themed 360º video (e.g., beach, waterfall, songbirds) for approximately 8 minutes, accompanied by synchronized natural sounds. The VR experience is designed to promote distraction, relaxation, and emotional engagement with nature to support pain relief and emotional regulation. The equipment is sanitized betwe
• Препарат Standard Pain Management
  Participants in this group will receive the institution's standard pharmacological pain management, monitored and adjusted by the Pain Control Team using the hospital's electronic medical record system. This may include opioid and non-opioid analgesics according to clinical evaluation. No complementary interventions will be provided during the study period.

Первичные конечные точки

• Visual Analogic Scale for Pain [Срок оценки: Immediately post-intervention for an unique virtual reality intervention]
• Frequency of analgesic administration Frequency of analgesic administration Frequency of analgesic administration [Срок оценки: 24 hours post-intervention]
• Total dosage of analgesics administered [Срок оценки: 24 hours post-intervention]
• Type of analgesics administered [Срок оценки: 24 hours post-intervention]

Вторичные конечные точки (1)

• The Positive and Negative Affect Schedule (PANAS) [Срок оценки: Immediately post-intervention for an unique virtual reality intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Бразилия · 1 центр

• Hospital Albert Einstein — São Paulo

Публикации

• Kelleher SA, Fisher HM, Winger JG, Miller SN, Amaden GH, Somers TJ, Colloca L, Uronis HE, Keefe FJ. Virtual reality for improving pain and pain-related symptoms in patients with advanced stage colorectal cancer: A pilot trial to test feasibility and acceptability. Palliat Support Care. 2022 Aug;20(4):471-481. doi: 10.1017/S1478951521002017. PMID 35078545
• Britton E, Kindermann G, Domegan C, Carlin C. Blue care: a systematic review of blue space interventions for health and wellbeing. Health Promot Int. 2020 Feb 1;35(1):50-69. doi: 10.1093/heapro/day103. PMID 30561661

Идентификаторы

NCT: NCT07053228 · 86844425.5.0000.0071

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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