e-Natureza Blue Care: Nature-based Virtual Reality and Pain Perception
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Israelita Albert Einstein
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nature-based virtual reality
BehavioralParticipants 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 between uses according to hospital infection control protocols.
Standard Pain Management
DrugParticipants 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.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Intervention - Nature-based Virtual RealityExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analogic Scale for Pain
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.
Time frame
Immediately post-intervention for an unique virtual reality intervention2
Frequency of analgesic administration Frequency of analgesic administration Frequency of analgesic administration
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.
Time frame
24 hours post-intervention3
Total dosage of analgesics administered
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.
Time frame
24 hours post-intervention4
Type of analgesics administered
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.
Time frame
24 hours post-interventionSecondary outcomes
1
The Positive and Negative Affect Schedule (PANAS)
Change from Baseline Affective States at post-intervention. PANAS is a 20-item self- report measure to assess positive affect (PA) and negative affect (NA). It is one of the most used instruments in the investigation of affective states composed of 20 questions and each item can be rated on a likert type frequency scale of sensations, ranging from 0 (not at all) to 5 (extremely).
Time frame
Immediately post-intervention for an unique virtual reality interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: