Cancer Paine-NatBlueNCT07053228
e-Natureza Blue Care: Nature-based Virtual Reality and Pain Perception
A study testing Nature-based virtual reality and Standard Pain Management in people with Cancer Pain and Palliative Care, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Palliative Care
- What is being tested?
- Nature-based virtual reality and Standard Pain Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Aug 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital Albert Einstein
São Paulo, São Paulo
Eliseth R Leão, PhD, eliseth.leao@einstein.br
Cibele T Souza, BSN, cibele.teixeira@einstein.br
About this study
Official title: e-Natureza Blue Care - Impact of Virtual Reality on Pain Perception, Mood States, and Analgesic Use in Patients With Cancer Pain: Randomized Clinical 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.
Read the detailed description
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.
- Conditions
- Cancer Pain, Palliative Care
- Being tested
- Nature-based virtual reality, Standard Pain Management
- Keywords
- Cancer Pain, Palliative care, Virtual reality
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-based virtual realityBehavioural
Also called Non-pharmacological pain relief
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.
Standard Pain ManagementDrug
Also called Pharmacological pain relief
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard Pain Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours post-intervention
Secondary 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).
Measured: Immediately post-intervention for an unique virtual reality intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliseth Ribeiro Leao, Hospital Israelita Albert Einstein
- Investigators
- Eliseth R Leão, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053228
- Sponsor's protocol ID
- 86844425.5.0000.0071
- Acronym
- e-NatBlue
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35078545Britton 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.
PubMed 30561661
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-Natureza Blue Care - Impact of Virtual Reality on Pain Perception, Mood States, and Analgesic Use in Patients With Cancer Pain: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07053228
- Acronym / sponsor ID
- e-NatBlue / 86844425.5.0000.0071
- Conditions
- Cancer Pain, Palliative Care
- Keywords
- Cancer Pain, Palliative care, Virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention - Nature-based Virtual Reality | Experimental | Behavioral: Nature-based virtual realityParticipants 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. |
| Control | Active comparator | Drug: Standard Pain ManagementParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nature-based virtual realityAlso: Non-pharmacological pain reliefParticipants 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. | Behavioural | Intervention - Nature-based Virtual Reality |
| Standard Pain ManagementAlso: Pharmacological pain reliefParticipants 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. | Drug | Control |
Primary outcome
Visual Analogic Scale for Pain
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
The Positive and Negative Affect Schedule (PANAS)
Time frame: Immediately post-intervention for an unique virtual reality intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 35078545Kelleher 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.
- Background: PubMed 30561661Britton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eliseth R Leão, PhD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature-based virtual reality and Standard Pain Management in people with Cancer Pain and Palliative Care, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eliseth R Leão, PhD (+5511996186489, eliseth.leao@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogic Scale for Pain (time frame: Immediately post-intervention for an unique virtual reality intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07053228, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.