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

NCT07053228 | Not Yet Recruiting DMC

• 1 other identifier: 86844425.5.0000.0071
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Pain; Palliative Care

Keywords

Cancer Pain; Palliative care; Virtual reality

Outcome Measures

Primary Outcomes (4)

• 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.

  Immediately post-intervention for an unique virtual reality intervention

• 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.

  24 hours post-intervention

• 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.

  24 hours post-intervention

• 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.

  24 hours post-intervention

Secondary Outcomes (1)

• The Positive and Negative Affect Schedule (PANAS)

  Immediately post-intervention for an unique virtual reality intervention

Study Arms (2)

Intervention - Nature-based Virtual Reality

EXPERIMENTAL

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.

Behavioral: Nature-based virtual reality

Control

ACTIVE COMPARATOR

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.

Drug: Standard Pain Management

Interventions

Nature-based virtual reality BEHAVIORAL

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 between uses according to hospital infection control protocols.

Also known as: Non-pharmacological pain relief

Intervention - Nature-based Virtual Reality

Standard Pain Management DRUG

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.

Also known as: Pharmacological pain relief

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Albert Einstein

São Paulo, São Paulo, Brazil

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eliseth R Leão, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliseth R Leão, PhD

CONTACT

+5511996186489; eliseth.leao@einstein.br

Cibele T Souza, BSN

CONTACT

+5511981974214; cibele.teixeira@einstein.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Scientist

Model Details: This is a randomized clinical trial, an experimental study involving human subjects aimed at evaluating the effect of a health-related intervention. After signing the informed consent form, participants will be randomly assigned via the Randomizer software to either the control or intervention group. Patients in the control group will receive standard pain management, which includes pharmacological treatment and monitoring through electronic medical records (EMRs). When pain is not adequately controlled, the institutional Pain Management Team conducts an in-depth EMR review to tailor care, ensuring effective and continuous pain relief. The intervention group will receive standard care plus immersive nature-based virtual reality therapy. Five tools will be used for data collection: a Sociodemographic and Clinical Questionnaire, the Visual Analogue Scale , the Positive and Negative Affect Schedule , the Nature Connectedness Scale (NCS), and the Analgesic Experience Questionnaire

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 8, 2025
• Study Start: August 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: March 30, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)