nctId: NCT06328751 id: 76043823.0.0000.0004 briefTitle: Meditation With Virtual Reality for Cancer Pain Relief in the Pain Therapy and Palliative Care Service overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2025-06-30 date: 2025-08-30 date: 2024-03-25 date: 2024-03-25 name: Emily Santos Montarroyos class: NETWORK name: AC Camargo Cancer Center briefSummary: Cancer is a disabling, challenging and growing global disease. Although early diagnosis and adequate treatment of oncological disease have been developing rapidly, a large part of the population remains without access to specialized services and routinely evolve to symptoms and sequelae with uncontrolled pain, worse quality of life and suffering. Complementary therapies to control pain and improve the well-being of cancer patients are fundamental tools of integrative oncology medicine. This study proposes to use immersive virtual reality to encourage cancer patients to carry out the regular practice of meditation, as an effective tool in pain management and in the search for a better quality of life, based on a structured intervention that encourages autonomy as important part of your treatment. Two studies will be carried out at the Pain Therapy and Palliative Care Service of the Amazonas State Oncology Control Center Foundation (FCECON). Study 1 will be a cross-sectional study to describe the variables associated with the diagnosis and treatment of patients' pain and Study 2 will be a Randomized Controlled Trial that will analyze the impact of an intervention performed with meditation through immersive virtual reality for pain relief. pain in these patients. It is expected that the regular practice of meditation through immersive virtual reality will promote pain relief and improve the quality of life of cancer pain patients. conditions: Cancer Pain conditions: Quality of Life conditions: Palliative Medicine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, experimental, longitudinal, randomized controlled trial (RCT), carried out in three stages. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Randomization will be carried out using a specific application called Randomizer ® for Clinical Trial Lite, which is a secure and validated application that works with encrypted network traffic using Transport Layer Security (TLS), a strong encryption. There will be 3 groups which will be divided into the Case Group, the Active Control Group and the Passive Control Group. Each patient will be seen individually wearing a Samsung® smartwatch and will not know about the other patients' meditation. The case group will watch a 7-minute immersive virtual reality video of mindfulness meditation with image and sound in the Oncology Control Center Foundation (FCECON) office, using Samsung® gear VR virtual reality glasses. The active control group will watch a 7-minute mindfulness meditation video presented via cell phone with image and sound at the office. The passive control group will perform breathing exercises based on the healthcare professional's instructions for 4 minutes in the office. whoMasked: PARTICIPANT count: 129 type: ESTIMATED name: Case group name: Active control group name: Passive control group measure: Brief Pain Inventory (Reduced version) measure: McGill Quality of Life Questionnaire measure: Hospital Anxiety and Depression Scale (HADS) measure: The Edmonton Symptom Assessment Scale (ESAS) measure: The National Comprehensive Cancer Network® (NCCN) Distress Thermometer sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False